In-Depth Technical Overview of Veeva Vault eTMF

Introduction

Veeva Vault eTMF is a cloud-based electronic trial master file system designed specifically for managing clinical trial documentation with a high degree of efficiency, control, and compliance (eTMF Overview | Vault Help) (Veeva eTMF | Improve Trial Efficiency & Inspection Readiness | Veeva). Part of Veeva’s Vault Clinical Operations suite, Vault eTMF provides real-time access to TMF content for sponsors, CROs, sites, and auditors throughout a trial’s setup, execution, and archival phases (eTMF Overview | Vault Help). It fully supports the latest Trial Master File Reference Model (TMF RM) standards to ensure that all essential documents are properly categorized and managed according to industry taxonomy (eTMF Overview | Vault Help). As the leading eTMF application in the life sciences industry, Veeva Vault eTMF is used to ensure the quality, timeliness, and completeness of TMF records (Veeva eTMF | Improve Trial Efficiency & Inspection Readiness | Veeva). This comprehensive report delves into the technical architecture, system design, and key capabilities of Veeva Vault eTMF – including document lifecycle management, metadata and taxonomy controls, security and compliance features, and integration and scalability – to illustrate how the platform enables active TMF management and constant inspection readiness (Link).

Platform Architecture and Technical Stack

Veeva Vault eTMF is built on the multi-tenant Vault Platform, an enterprise cloud platform architected from the ground up to manage both content and data for life sciences applications (Veeva Vault Platform | Veeva). In a multi-tenant architecture, all customers operate on a shared infrastructure and codebase, benefiting from the same updates and performance optimizations, while strict partitioning ensures each customer’s data remains isolated and secure (Link). The Vault Platform’s technical stack follows a modular approach: a relational database layer stores application metadata, configurations, and structured object data; a content-addressable file store backed by cloud storage (AWS S3) holds the documents and files; and a full-text index supports fast searching (Link). For example, document metadata and configurations are stored in the database, whereas the large binary files (PDFs, Word documents, etc.) are stored in an encrypted file system and S3 buckets, with the database maintaining pointers to those files (Link). This separation of metadata and content allows efficient querying and integrity control on metadata while handling large files via the scalable cloud storage.

The web-based application tier provides a unified interface to both data and documents through the Vault user interface and APIs. Vault eTMF leverages modern web technologies and a service-oriented architecture to deliver a responsive user experience in the browser, without requiring any client-side installation. The platform supports high concurrency and global access by distributing load across multiple application servers (referred to as “PODs” or points of delivery) in geographically dispersed data centers (Veeva Vault POD Details | Veeva Vault Release Notes). In practice, Vault PODs are hosted in multiple regions (e.g. East and West US, Europe, and Asia-Pacific) so that each customer’s Vault can reside in a region optimal for their operations and regulatory needs (Veeva Vault POD Details | Veeva Vault Release Notes). This global, cloud-native architecture not only provides low-latency access for users around the world, but also facilitates seamless scaling – Veeva can dynamically allocate computing resources across the multi-tenant environment to handle increasing numbers of users or documents without performance degradation. The Vault Platform has been proven in production for over a decade, supporting 50+ applications across clinical, regulatory, quality, and commercial domains in a high-performance, validated cloud environment (Veeva Vault Platform | Veeva). In summary, Veeva Vault eTMF’s technical stack consists of a robust multi-tenant cloud infrastructure (running on AWS), a secure database and storage design for content management, and a scalable application layer, all optimized to meet the rigorous requirements of life sciences for performance and reliability (Link).

System Design Principles and Scalability

Several core design principles underlie the Vault eTMF system: scalability, configurability, and continuous validation. From inception, the Vault Platform was built to satisfy the performance and scalability demands of managing large volumes of regulated content and data in the cloud (Link). The multi-tenant model means all customers are on the latest release, and the system can be enhanced uniformly – this fosters a “continuous improvement” approach where Veeva delivers multiple validated releases per year to all Vaults. Each release of Vault eTMF is installation-qualified and operational-qualified by Veeva, with a comprehensive validation package provided, ensuring that new features or changes do not compromise the system’s validated state (Veeva Vault Platform | Veeva). This risk-based change management approach (aligned with GAMP5 and regulatory guidance) allows Vault eTMF to evolve rapidly while maintaining compliance and integrity for GxP use (Link) (Link).

Configurability is a key principle: instead of one-off custom code for each customer, Vault eTMF provides a rich configuration layer (for objects, fields, lifecycles, workflows, security roles, etc.) so that each organization can tailor the eTMF to their processes without altering underlying code. This ensures that upgrades are painless and all customers benefit from a common, well-tested codebase. The platform’s open APIs and extension capabilities (e.g. Vault Java SDK) further allow adding integrations or slight customizations in a controlled manner (Veeva Vault Platform | Veeva) (Veeva Vault Platform | Veeva).

In terms of scalability, Vault eTMF is designed to handle enterprise-scale trials and programs involving thousands of users and millions of documents. The backend leverages the elasticity of cloud infrastructure – databases are optimized and indexed for fast retrieval of document metadata, and file content is streamed from S3 with caching to ensure quick document viewing. Because all customers share the highly optimized infrastructure, even smaller organizations benefit from the same robust performance tuning that large pharmaceutical companies require. Vault’s tenured production experience in life sciences and continuous performance testing have proven its ability to scale without significant degradation, even as data volumes grow. Workloads are balanced across multiple pods and servers, and the stateless application tier can scale horizontally (adding more server instances) to meet peak demands. As a result, Vault eTMF can support concurrent access by large global study teams and the ongoing accumulation of TMF documents throughout a study’s life, all while maintaining responsive performance. This scalable, cloud-native design ensures that organizations do not outgrow the system; whether managing one trial or a global portfolio of trials, the eTMF remains performant and available. Furthermore, by centralizing all content in one platform, Veeva enables efficiencies like cross-study reporting and data mining that would be difficult in siloed or on-premise systems.

Document Lifecycle Management and TMF Structure Compliance

Veeva Vault eTMF provides robust capabilities to manage the entire lifecycle of trial documents, from creation and draft, through reviews and approvals, to final archival. The platform allows administrators to define document lifecycles that model the business process for each type of TMF document. At a basic level, lifecycles consist of states (e.g. Draft, In Review, Approved, Final, Archived) and state-driven rules (permissions, required approvals, signature requirements, etc.). When a document moves through its lifecycle (often via workflow tasks), Vault automatically enforces the controls at each stage – for example, only users with the appropriate role can edit a document in Draft, a document cannot exit the Review state until the required approver(s) have approved and applied 21 CFR Part 11-compliant electronic signatures, and once in Final, the content is frozen (read-only) except to users with special privileges like administrative override (Veeva Vault Platform | Veeva). These lifecycle controls ensure documents progress through proper review and approval steps, maintaining compliance with SOPs and regulatory expectations for document handling. The system can also trigger automated actions at lifecycle transitions (e.g. notifying the next reviewer, or watermarking an approved PDF), thanks to Vault’s configurable workflow and lifecycle event framework (Veeva Vault Platform | Veeva). All of this means the document’s status in the TMF is always known and controlled, providing auditability from draft through retirement.

Equally important, Vault eTMF is designed for strict TMF structure compliance. It comes preconfigured with support for the TMF Reference Model (TMF RM), a standardized taxonomy and hierarchy for trial master file content developed by industry consortiums. Vault eTMF’s data model includes standard objects called “Model” and “Artifact” that represent the TMF Reference Model and its artifact definitions (eTMF Overview | Vault Help). Each Artifact corresponds to a document type or placeholder in the TMF (for example, an Artifact for Protocol, one for Investigator Brochure, one for IRB approval letter, etc., covering all core and recommended documents in the reference model). Vault eTMF maps actual documents to these artifacts through metadata. In practice, every document in Vault eTMF is assigned a Document Type (and subtype, etc.) which is in turn mapped to a TMF Reference Model Artifact and zone. This enables Vault to dynamically organize and view the TMF hierarchy according to the standard model. Using the built-in TMF Viewer, users can browse the TMF content in a hierarchical folder-like view that mirrors the Reference Model structure (zones -> sections -> artifacts) instead of a flat library (Using the TMF Viewer (eTMF) | Vault Help) (Using the TMF Viewer (eTMF) | Vault Help). The TMF Viewer can switch between multiple configured hierarchies – for instance, one view might be the TMF Reference Model, another could be a custom sponsor-defined hierarchy – thereby supporting organizations that have adopted the TMF RM or those with bespoke filing structures (Using the TMF Viewer (eTMF) | Vault Help) (Using the TMF Viewer (eTMF) | Vault Help). Vault only displays sections in the TMF tree when documents exist for them, which helps users see at a glance which expected artifacts have content and which are missing (Using the TMF Viewer (eTMF) | Vault Help) (Using the TMF Viewer (eTMF) | Vault Help).

To maintain alignment with evolving industry standards, Veeva provides updates to the Model/Artifact object configurations when new versions of the TMF Reference Model are released. Vault eTMF includes TMF Index Management capabilities to version and manage the TMF index (the artifact list) over time (eTMF Overview | Vault Help). This allows organizations to adopt a new TMF model version and still retain historical mapping for studies started under an older model. In summary, Vault eTMF ensures that documents are not just stored, but systematically classified and organized in compliance with a formal TMF structure. The entire document lifecycle is tracked and linked to this structure, providing end-to-end traceability. By automating lifecycle controls and structuring content per the TMF Reference Model, Vault eTMF makes it significantly easier for sponsors and CROs to adhere to regulatory expectations and ICH GCP guidelines for maintaining an organized, complete, and contemporaneous TMF. In an Active TMF operating model, documents are filed in real-time and their lifecycle status and TMF location are always up-to-date, eliminating the end-of-study document scramble and ensuring the TMF remains inspection-ready throughout the trial (Link).

Metadata Schema, Classification, and Taxonomy Controls

Underlying Veeva eTMF’s content management is a rich metadata schema that captures all relevant attributes of each document, enabling powerful classification, search, and reporting. Every document stored in Vault eTMF carries metadata fields such as Study, Study Country, Study Site, Document Type, Artifact (TMF category), Owner, Status, Effective Date, etc. These fields form a controlled vocabulary and taxonomy that drives how documents are organized and managed. For example, the combination of Study, Country, Site, and Artifact metadata lets the system uniquely place a document in the TMF hierarchy and also filter or retrieve documents by trial or site. Many of these fields are linked to reference objects: Study links to a Study record in the system (defining protocol ID, title, etc.), Artifact links to the TMF Reference Model artifact definition, Document Type is often a picklist constrained by the Artifact selection (so that users classify documents correctly). This controlled metadata approach enforces consistency – users cannot arbitrarily name or file documents; they must assign them to predefined categories. Vault eTMF’s default configuration comes with the entire set of TMF Reference Model artifact definitions and document type taxonomy pre-loaded, which means out-of-the-box it knows about all expected document categories for a clinical trial (eTMF Overview | Vault Help). Sponsors can further configure metadata (adding custom fields or additional classifications) but typically the standard taxonomy suffices to cover regulatory requirements.

A notable feature for classification is TMF Bot, an AI-powered utility in Vault eTMF that assists with automatic document classification and metadata population (eTMF Overview | Vault Help). TMF Bot uses machine learning models (trained on vast numbers of TMF documents) to analyze incoming documents and predict their appropriate classification (Artifact and other key metadata like document date or site). When users drag-and-drop or email in a batch of documents to the Vault’s Document Inbox, TMF Bot can automatically suggest or set the Document Type/Artifact and even fill certain fields (e.g. it might recognize a document as a Site IRB Approval for Study X at Site Y and populate those fields) (eTMF Overview | Vault Help). This automation accelerates filing and reduces errors in taxonomy assignment, ensuring documents don’t get misfiled outside the defined TMF structure. Administrators can configure which metadata TMF Bot will set and continuously improve the model by providing feedback or uploading sample documents for training (eTMF Overview | Vault Help) (eTMF Overview | Vault Help).

Beyond AI, Vault eTMF enforces taxonomy through auto-filing rules. One example is the Document TMF Auto-Filing feature, which uses the metadata to automatically place a document into the correct binder in the TMF hierarchy (for study, country, site) upon import (eTMF Overview | Vault Help). Essentially, if a document is tagged with Study = ABC123, Country = US, Site = 1001, and Artifact = “Site Initiation Report”, Vault will automatically put it in the TMF Viewer under the ABC123 study, US country, Site 1001 node, in the Site Initiation Report placeholder. This saves end-users from manually moving documents into folder structures and prevents filing mistakes.

The metadata schema is highly configurable but always controlled. Administrators can add custom fields or picklist values if needed (for instance, to track additional attributes like whether a document is a certified copy, or to tag a region or therapeutic area). All changes are versioned and subject to Vault’s validation processes, meaning the integrity of the classification scheme is maintained over time. The combination of enforced picklists, required fields, and validation rules ensures that critical metadata (like Study and Artifact) are always populated, which in turn drives the completeness metrics. Vault eTMF also supports defining Expected Document Lists (EDLs) per study via metadata objects – an EDL is essentially a list of artifact categories expected for a given study (possibly refined by phase or country) and can be loaded as metadata. Each EDL entry can then be automatically checked off when a real document of that category is filed. This metadata-driven approach allows the system to dynamically track completeness (more on that in a later section).

In summary, Vault eTMF’s metadata and taxonomy controls guarantee that every document is classified in accordance with a standard TMF model and enriched with attributes that facilitate retrieval and oversight. Advanced tools like TMF Bot and auto-filing further streamline classification, freeing users from manual taxonomy work while increasing accuracy. These controls form the backbone that enables real-time TMF visibility – because when all documents are consistently tagged and filed, the application can reliably tell you which documents you have, which you’re missing, and where each document is in its lifecycle.

Role-Based Access Control and Permission Management

Managing who can access what in the TMF is critical given the sensitive and regulatory nature of clinical trial documents. Veeva Vault eTMF employs a fine-grained, role-based access control (RBAC) model to ensure each user sees and can do only what they are permitted, based on their role and context. Security in Vault is enforced at multiple levels – authentication (verifying the user’s identity), authorization (controlling what actions that user can take on which records), and audit safeguards (tracking every user action) (Link). At a high level, each user is assigned one or more profiles/roles that determine their functional privileges (e.g. ability to read documents, edit documents, approve workflows, etc.), and they can also be scoped to certain studies or organizational units for data partitioning.

Vault eTMF introduces the concept of a Study Team and the Study Person object to facilitate role assignment in a study-specific way (eTMF Overview | Vault Help). Rather than having to create separate vaults or complicated folder permissions per study, Vault eTMF allows administrators to assign a user to a particular study (and optionally to specific countries or sites within that study) with a defined role. For example, a user Alice could be added as a “Clinical Operations Lead” role on Study ABC, which grants her edit/review permissions on documents for that study, while Bob could be a “Read-Only Auditor” on the same study, and Carol might have “Document Contributor” role but only for Site 1001 within Study ABC. The system will automatically scope their access so that Alice and Bob see all documents for Study ABC (with Alice having greater edit rights, Bob read-only), and Carol sees only those documents belonging to her site. This “atomic” level security ensures that sponsors, CROs, site personnel, and external parties can work in the same vault application while maintaining strict segregation of access (Link). A sponsor user with appropriate role can potentially see all studies in their vault, whereas a site user might only see documents for their site, and an auditor might be given a special read-only role across a subset of studies for inspection purposes (Link). Vault administrators manage these assignments centrally, and changes propagate instantly (removing a user from a study team revokes their access to those documents immediately, etc.).

Permissions in Vault eTMF can be configured to the object and field level as well. Administrators define security profiles for document objects that determine which roles can view, edit, or delete documents in certain states or of certain types. For instance, unapproved documents might be editable by their owners but read-only to others; or documents marked as “Confidential” could be restricted via an additional security label. Vault supports security labels to further tag content and include/exclude user groups (for example, marking certain documents as “Sponsor-Blinded” and excluding study team members from the CRO from seeing those). A common use case in trials is blinded vs. unblinded content: Vault eTMF provides a mechanism to designate documents as Unblinded (e.g. containing treatment allocation info) and restrict those documents to only users with an “Unblinded” permission, whereas all other users (blinded team) cannot access them (eTMF Overview | Vault Help). This ensures integrity in double-blind trials – unblinded pharmacy or biostats users can upload unblinded documents (like randomization lists) that investigators and monitors (blinded roles) cannot open. The system design thus inherently supports role-based blind-breaking controls.

From an identity management perspective, Vault integrates with enterprise Single Sign-On (SSO) solutions, meaning user accounts and roles can be managed via corporate identity providers. Vault supports SAML 2.0 for SSO, allowing users to authenticate with their corporate credentials and have Vault trust those identities (Vault Integrations). This not only improves security (centralized password policies, multi-factor authentication) but also simplifies provisioning – a new hire can be given access to Vault eTMF via the central directory and appropriate SSO group membership, and then Vault roles can be assigned accordingly. For organizations that invite external users (like site staff or external auditors), Vault can also manage native accounts with configurable password policies (minimum length, complexity, expiration) as per industry best practices (Link). All login attempts and access events are logged for security oversight (Link).

In summary, Vault eTMF’s RBAC system provides granular control over TMF access, aligning with the collaboration model of modern trials (which involve multiple stakeholders). By mapping roles to study scope, the system ensures each user’s view of the TMF is limited to their need-to-know portion. Powerful configuration options exist to handle special cases like unblinded data or specific document restrictions. These access controls are enforced consistently by the platform’s security engine, which checks user permissions on every action and object. Combined with strong authentication and identity integration, this means Vault eTMF can securely accommodate internal users, partners, and even regulators on the same platform without risking unauthorized data exposure. The principle of least privilege is effectively implemented – only users with valid credentials and proper access rights can view or modify TMF content in Vault eTMF (Link).

Real-Time Collaboration and Version Control Mechanisms

Veeva Vault eTMF enables real-time collaboration on trial documents by providing a single, always-accessible platform where all authorized stakeholders can work together on the TMF. Version control is intrinsic to the content management system: every document in Vault eTMF maintains a full version history, ensuring that edits are tracked and previous versions are preserved. When a user checks out a document to edit, Vault creates a new version upon check-in, incrementing the version number (with major/minor versioning support). This guarantees that the TMF retains copies of superseded documents – nothing is lost, and one can always retrieve or view an earlier version for audit or reference. Only one user at a time can formally check out a document for editing to prevent conflicting changes, but others can still view the last released version in the meantime. Vault also supports document annotations and comments, allowing collaborators to mark up a document with electronic sticky notes or highlights (for example, during a review cycle) without altering the source content (Veeva Vault Platform | Veeva). These collaboration features replace the old method of emailing documents around or using shared network drives, providing instead a single source of truth in real-time.

Notably, Vault eTMF integrates with Microsoft Office Online to enable true real-time co-authoring on content like Word documents. Through a seamless integration, users can open a document in the web-based Office 365 editor directly from Vault and multiple team members can concurrently edit the document with live updates, all within a controlled, audit-trailed environment (Link). This real-time collaborative authoring is done “in place” on the Vault document – meaning there is no need to download, edit offline, and re-upload; the online Office integration writes changes back to the Vault in real-time. Throughout this process, Vault maintains compliance (for example, it can require a formal check-in when editing is done to increment the version and capture an audit trail entry). The integration is designed to be compliant with Part 11, so even though co-authoring is live, every significant action (like finalizing the document) is still captured, and if an approval or signature is needed, it is done via Vault’s controlled workflow after editing. This capability greatly enhances productivity for tasks like authoring protocols, monitoring visit reports, or other TMF documents where multiple contributors (perhaps from sponsor and CRO) need to work on the same file simultaneously.

Collaboration is further facilitated by Vault’s workflow engine. Users can send documents on review or approval workflows to other users, who get notified and can then access the document in Vault to provide input or sign off. These workflows can be sequential or parallel (multiple reviewers at once), and Vault will track responses, consolidate comments, and move the process along according to defined timelines. During a workflow, the document is locked in a certain state (e.g. “In Review”) and only accessible in read-only form to the reviewers, preserving version integrity until the workflow completes. The tasks assigned by workflows appear in the users’ task lists and on dashboards, ensuring everyone knows what actions are pending on them. This structured collaboration means that no document should linger awaiting approval without accountability – Vault can send reminders or escalate tasks if deadlines are missed. In practical terms, a TMF document like a site monitoring report can be drafted by a CRA, routed to the clinical lead for review, then to a project manager for approval, all within Vault with each person working off the same record and all actions time-stamped. This eliminates the confusion of multiple document copies and captures the entire collaborative process in the audit trail.

Vault’s cloud nature means real-time access for all participants. The sponsor and CRO teams, and even investigator site personnel (if given access), are always working on the live TMF. There is no need to periodically reconcile separate copies of the TMF – everyone sees the current status of documents in real-time. If a CRA from a CRO uploads a new document, the sponsor can see it immediately; if the sponsor adds a comment or request for clarification on a document, the CRO can see that instantly. This immediate visibility extends to TMF metrics too (discussed later) – e.g., completeness percentages update as soon as new documents are filed (Link). Real-time collaboration in Vault eTMF thus breaks down silos between partners. It supports a truly “active TMF” model where the TMF is a living, breathing repository being actively updated and quality-checked throughout the conduct of the trial, rather than a static archive assembled after the fact (Link).

Lastly, the platform’s version control and collaboration features ensure that when inspection time comes, there is a single final version of each required document with clear traceability of how it was created and approved. Inspectors can see the version history and even view the draft versions if needed, showing the evolution of a document. They can also see who collaborated on it, who approved it, and when – demonstrating compliance with procedural requirements. In effect, Vault eTMF provides not just a file repository, but a collaborative workspace for clinical documentation that preserves a complete history of contributions and decisions. By combining real-time editing, structured workflows, and strict versioning, Vault eTMF significantly improves the efficiency of document creation while upholding the rigorous control needed in a GxP environment.

Integration Capabilities with CTMS, EDC, and EDMS Systems

Modern clinical operations require different systems to work in concert – an eTMF rarely stands completely alone. Veeva Vault eTMF is built with integration in mind, offering multiple pathways to connect with Clinical Trial Management Systems (CTMS), Electronic Data Capture (EDC) systems, and other content or data management systems (EDMS). Because Vault eTMF is part of the broader Vault Clinical suite, it can function as a unified solution with Veeva’s CTMS, study startup, payments, and other clinical applications on the same platform (Link). In such a configuration, the eTMF and CTMS actually share a common database and data model, meaning there is no need for interfacing – the study, country, site, and milestone data seen in eTMF is the very same data being used by CTMS for site management and monitoring. For example, if a new site is added and activated in Vault CTMS, that site record is immediately available in Vault eTMF so that documents can be filed against it. This unified platform approach (with Vault acting as a single source of truth for both operational data and documents) drastically reduces reconciliation efforts and ensures consistency across clinical operations (Link) (Link).

However, organizations often use third-party or legacy systems. Vault eTMF provides robust integration capabilities via its open REST APIs and integration tools. For CTMS, Veeva has developed standard integrations such as the one with Medidata CTMS (formerly part of Rave). The Medidata CTMS Integration for Vault eTMF allows Vault to consume study information from Medidata – study, study country, site details can flow in, and importantly, monitoring visit reports authored in Medidata CTMS can be automatically transferred and filed in the Vault eTMF (eTMF Overview | Vault Help). This means if a monitor writes a visit report in the CTMS, once finalized, that report (and possibly associated trip report document) will appear in the TMF without manual upload. Likewise, Vault eTMF can send status information back, enabling a two-way sync so that both systems reflect up-to-date information.

Integration with EDC systems is another common scenario, primarily to get final Case Report Forms (CRFs) or data outputs into the TMF for archival. Vault eTMF offers a feature called CRF Import (eTMF Overview | Vault Help), which is designed to take a bulk output of subject casebooks from an EDC (like Medidata Rave or Veeva CDMS) and automatically import them as TMF documents. Using this, at end of study (or interim timepoints), the sponsor can export all signed PDF CRFs from the EDC and then feed them into Vault eTMF, where they will be auto-classified (e.g. as CRF for each subject) and filed under the appropriate trial and site. This saves enormous time compared to printing and scanning CRFs or manually uploading each file. The CRF Import can be configured to map metadata (for instance, picking up subject IDs, etc., if needed as metadata fields). Thus, EDC data, once frozen, can seamlessly become part of the eTMF. If using Veeva’s own EDC (Vault CDMS), similar integration is possible since it’s on the Vault Platform – data or documents can flow through Vault’s back-end without even needing file transfers, though in practice, one might still produce PDF renditions for TMF completeness.

For other EDMS or content systems, Vault’s open API allows for integration to push or pull documents. Many sponsors use migration or middleware tools (like ESBs or iPaaS) to connect Vault with legacy document repositories. Vault’s API supports document creation, metadata update, download, search queries, etc., which means an external system could query Vault for a list of expected documents and then fulfill any missing ones by transferring files in. Likewise, Vault eTMF could serve as the central repository that feeds other systems – for example, a regulatory submissions system might pull certain final documents from the eTMF to include in an FDA submission. Veeva provides SDKs and connectors for various integration scenarios, and partners have built pre-built connectors (for instance, to connect Vault to SharePoint or to scanning systems). Common patterns include nightly data sync jobs (using Vault’s REST APIs or CSV export/import) and real-time event-driven integrations (Vault can send outbound messages or use a message queue when certain actions occur). The Vault Platform also supports a Direct Data API for high-throughput data extraction, useful if a data warehouse needs to ingest Vault eTMF metadata in bulk for analytics (Veeva Vault Platform | Veeva).

To facilitate collaboration with investigator sites, Veeva offers Site Vault and Site Connect which integrate with Vault eTMF as well. In a Site Vault integration, investigator site staff use their own SiteVault (an eISF – electronic investigator site file) and documents can transfer to the sponsor’s Vault eTMF through a controlled connection (maintaining an authoritative copy on each side). The TMF Transfer capability of Vault eTMF allows a sponsor to package up and transfer TMF documents from one Vault to another – particularly between a CRO’s vault and a sponsor’s vault (Link). For example, if a CRO is managing the TMF in their own Vault eTMF and the sponsor has their Vault, at the end of the study the CRO can, with one click, transfer the entire TMF (or incremental documents) to the sponsor’s Vault. This feature moves documents along with their metadata and audit trail information, preserving the integrity of the records (Link). It eliminates manual handover or re-uploading of files and ensures the sponsor gets a complete and compliant copy of the TMF for long-term archival. The audit trail of the transfer itself is logged, and unique record identifiers are maintained to avoid duplication. This kind of Vault-to-Vault integration leverages the fact that both sides are on the Vault platform – making what would traditionally be a complex migration into a straightforward system operation.

From an enterprise IT perspective, Vault eTMF can be integrated into the wider ecosystem with relative ease. It supports single sign-on integration (as mentioned earlier), meaning it can fit into the company’s identity management landscape (Vault Integrations). It also has web service APIs that external systems can call to retrieve data (say, to show a dashboard of TMF status in a portal) and it can consume external web services or data feeds. Vault’s integration endpoints are secured with industry standards (OAuth 2.0 for API authentication, for example) (Vault Integrations), and Veeva publishes integration best practices to ensure reliability and security (such as guidelines on bulk data handling, error recovery, etc. (Vault Integrations) (Vault Integrations)).

In summary, Veeva Vault eTMF is not a silo – it is designed to connect and share information with other clinical trial systems. Whether through out-of-the-box connectors (for CTMS, EDC, Safety systems, LMS for training records, etc.) or through well-documented APIs and tools, Vault eTMF can integrate into end-to-end workflows. This integration capability is crucial to achieving a “single source of truth” for clinical operations (Link), as it allows trial master file documentation to be in sync with the trial’s operational data and other artifacts. By reducing manual data entry and duplicate repositories, integration with Vault eTMF improves data quality and trial efficiency, ensuring that the eTMF is always aligned with the current state of the trial.

Compliance with Global Regulatory Standards (21 CFR Part 11, GCP, GDPR)

Vault eTMF is engineered to comply with the stringent global regulations governing electronic records in clinical trials, notably FDA 21 CFR Part 11, EU Annex 11, and ICH GCP requirements, as well as data protection laws like GDPR. 21 CFR Part 11 and EU Annex 11 set forth requirements for trustworthiness and reliability of electronic records and electronic signatures – Vault eTMF meets these requirements through a combination of technical controls, standard operating procedures, and validation documentation (Link) (Link). Veeva has conducted formal assessments to document compliance with Part 11 and Annex 11 regulations, implementing all required controls for open systems (i.e. systems accessible over a network that is not closed/proprietary) (Link). One such control is strong encryption of data at rest, which Part 11 recommends for open systems; Vault eTMF encrypts all document content stored on the file system to protect against unauthorized access to data outside the application (Link).

Electronic signatures in Vault eTMF are fully Part 11 compliant. When a user applies an e-signature (for instance, approving a document), Vault prompts for re-authentication (username/password) and requires the user to confirm a signature meaning (e.g. “Approved” or “Reviewed”). It then affixes the signature to the document, recording the name, timestamp, and meaning of the signature in an unalterable audit trail associated with the document. The signature manifestation (often a signature page or a stamp in the PDF) is stored, and the system prevents any changes to a signed record without invalidating the signature. These features align with Part 11’s requirements for electronic signature components, linking signatures to their records and preventing repudiation. Vault’s audit trail functionality also supports Part 11 compliance – it automatically logs every creation, modification, viewing, and deletion event on records, including the who, what, when of each action (Link) (Link). Audit logs in Vault eTMF capture before-and-after values of any changed fields, providing a complete history of the record over time (Link). These audit trails cannot be tampered with by end users and are readily available for inspection, satisfying regulatory expectations for traceability of changes (a key aspect of data integrity and Part 11).

Veeva’s quality system around Vault ensures validation and change control, which auditors often scrutinize for GxP systems. Vault eTMF is delivered with vendor-supplied validation packets (IQ/OQ) for each release (Veeva Vault Platform | Veeva), and Veeva’s internal processes comply with ISO 27001 and GAMP5 guidelines for software development and testing (Link) (Link). Regulatory inspectors and sponsor QA can review these validation documents to confirm that the system was tested to meet its intended use and that any changes go through proper regression testing. Moreover, Veeva’s SaaS change management approach is risk-based and transparent – customers are informed of upcoming releases, and critical vs. non-critical changes are identified to guide customers’ own change control (this aligns with regulatory expectations that the system owner manages changes in a controlled way even if the vendor maintains the system) (Link) (Link).

Regarding ICH GCP (Good Clinical Practice) guidelines, particularly ICH E6(R2) and the upcoming R3, Vault eTMF helps organizations meet the principles of data integrity, contemporaneous data capture, and sponsor oversight. GCP requires that sponsors maintain an adequate TMF that shows evidence of all trial conduct and oversight, and that it is readily available and auditable by inspectors. Vault eTMF’s active management of the TMF (with real-time updates and monitoring dashboards) is aligned with GCP’s emphasis on maintaining the TMF “contemporaneously” – i.e. filed in parallel with trial conduct, not months later (Link). The completeness tracking and audit trails demonstrate that the sponsor is diligently overseeing the collection of essential documents (addressing the GCP mandate that sponsors ensure all necessary documents are in place and that CROs are fulfilling their duties). Vault eTMF also supports compliance with specific regulatory guidance such as the EMA’s Guideline on TMF (which outlines requirements for electronic TMFs, like indexing, security, and accessibility) – we see these reflected in Vault’s features: a formal index aligned to a reference model, robust security controls, and the ability to provide auditors access or exports for inspections.

In terms of data privacy regulations (GDPR and related laws), Veeva Vault eTMF is designed to help customers meet requirements for protecting personal data. Clinical trial master files can include personal data (e.g. investigator CVs, patient initials in some documents, etc.), and under GDPR the sponsor (data controller) must ensure appropriate safeguards. Vault’s security architecture (described later) provides strong encryption and access control to prevent unauthorized exposure of personal data, which is a key technical measure. Additionally, Veeva offers data hosting in-region (EU data centers for European trial data, for example) to aid compliance with GDPR’s data residency and transfer rules. Veeva as a company is ISO 27001 certified and acts as a data processor under GDPR, meaning they have documented policies for data protection and will sign Data Processing Agreements (DPAs) with customers (Link). Features like precise role-based access help sponsors implement the “need to know” principle for personal data, and audit trails provide accountability for who viewed or changed personal information. If needed, specific personal data can be redacted or removed in line with GDPR rights (though in practice trial records are often exempt from deletion requirements until legally allowable). The system’s retention and deletion capabilities (discussed later) also support compliance with privacy laws by allowing disposition of data once it’s no longer required to be kept.

Additionally, Veeva Vault meets various other regulatory and industry standards: it adheres to 21 CFR Part 11 (US) and EU Annex 11 (EU) as noted, and Veeva has mapped controls to ISO 27001 (information security management standard) and even SOC 2 trust principles as part of their service attestations. The platform also supports compliance with FDA 21 CFR Part 312.62 and ICH E6 which require retention of trial records for specified durations – Vault’s archival and retention features ensure records remain accessible for the required time, intact and unaltered. In summary, compliance is not an afterthought in Vault eTMF; it is built into the system’s DNA. By providing the technical controls for e-signatures, audit trails, security, and validation, and by aligning with industry models for TMF, Vault eTMF gives clinical trial sponsors and CROs a tool that can stand up to regulatory scrutiny internationally. It reduces the burden of proving compliance, since many compliance features are automated or inherent to the system, allowing trial teams to focus on the content of the TMF rather than the mechanics of compliance.

Automated Quality Checks and Completeness Tracking

(TMF Homepage (eTMF) | Vault Help) The TMF Completeness widget in Vault eTMF provides real-time visibility into what percentage of expected documents have been collected, and highlights outstanding items (e.g. unapproved documents, overcounts, or pending decisions) that may require attention. This is one of several dashboard widgets that help trial teams proactively monitor TMF health.

Vault eTMF places a strong emphasis on ongoing quality control and completeness of the trial master file. Unlike the paper TMF days where a quality check might happen long after documents were filed (or not filed), Vault eTMF enables continuous monitoring of TMF quality throughout the study, with automated checks and reports to catch issues early. One key component of this is the concept of Expected Document Lists (EDLs) and completeness metrics. For each study (and even for each milestone within a study), the system can maintain an EDL – essentially the list of all document artifacts that are expected for that study (based on the trial phase, region, etc.). This expected list can be generated from the TMF Reference Model or via milestone templates (e.g. if a milestone “Site Initiated” is reached, it expects certain documents like SIV report, training logs, etc.). Vault eTMF uses the EDL as a benchmark against the actual documents present in the system to calculate completeness percentages (TMF Homepage (eTMF) | Vault Help). For instance, if 100 artifact types are expected and 90 have at least one document filed, the completeness might be 90% (with nuances like whether documents are approved or in draft). The TMF Homepage in Vault eTMF prominently displays these completeness metrics as interactive widgets (TMF Homepage (eTMF) | Vault Help). Users can drill down on the Completeness widget (as shown above) to see which expected items are missing or not finalized. It even shows counts of “unapproved documents” (drafts that need approval) and flags cases where there are more documents than expected (an overcount, which could indicate a document misfiled in the wrong category or duplicate) (TMF Homepage (eTMF) | Vault Help) (TMF Homepage (eTMF) | Vault Help). By providing this live completeness tracking, Vault eTMF empowers study teams to identify gaps and take action during the trial rather than after. Teams can download an Expected vs. Actual report or simply use the dashboard to answer questions like “Are we missing any essential documents for Site X?” or “How complete is the TMF for Trial Y as of today?” (TMF Homepage (eTMF) | Vault Help).

To support automated quality checks, Vault eTMF includes features like the Document Quality Check Workflow and the Quality Issues log. The Document Quality Check Workflow allows organizations to enforce a formal QC step on documents at key points (Link). For example, after a document is approved and finalized, it might enter a “Quality Check” state where an independent QC specialist must review it for correctness (proper signatures, no missing pages, proper classification, etc.) before it’s considered officially complete. Vault’s workflow can assign these QC tasks automatically, and the QC person can open the document and its metadata side-by-side to verify that everything is in order. The workflow provides a structured outcome (pass/fail or issues found) and can route the document back if corrections are needed. Because this is built into the system, it creates an audit trail of QC – showing that each document was checked, by whom, when, and what the result was. This satisfies many companies’ SOPs that require a secondary review of TMF content for quality. It also catches errors early: if a document is mis-indexed or missing a signature, the QC step will catch it and the document can be fixed while people and information are still readily available (instead of months later during an audit prep). As the datasheet notes, users can review document content and metadata simultaneously during quality check, making the process more efficient and reducing oversights (Link).

Vault eTMF also provides a Quality Issues object where any findings or discrepancies related to TMF documents can be logged and tracked (eTMF Overview | Vault Help). For example, if during an audit or QC someone finds that a document is illegible or an expected document is missing, they can create a Quality Issue record in Vault describing the problem. These Quality Issues can be categorized (e.g. Minor, Major, Critical) and assigned to owners to resolve. Having this within Vault means TMF issues are documented in the same system and can be linked to the related document or study, and reports can be run (e.g. number of open quality issues per study, time to resolution, etc.). This is very useful for inspection readiness – it provides evidence that the sponsor or CRO is actively monitoring TMF quality and fixing problems, a practice aligned with the ALCOA+ principles (specifically consistency and accuracy of records).

Another automation aiding quality is the timeliness tracking on the TMF Homepage (TMF Homepage (eTMF) | Vault Help) (TMF Homepage (eTMF) | Vault Help). Vault eTMF can calculate how long it took for documents to go from creation to final approval (or from event date to filing date) and present this as a metric. ICH GCP and the TMF Reference Model emphasize that documents should be filed in a timely manner. The Timeliness widget on the dashboard gives a snapshot (e.g. “45% of documents approved within X days, 55% took longer”) (TMF Homepage (eTMF) | Vault Help). This can highlight process bottlenecks – say, if a lot of documents are taking too long to get approved after being created, management can investigate why (perhaps approvers are overloaded or the workflow needs adjustment). By monitoring timeliness, teams ensure the TMF is not just complete, but also current.

In terms of completeness, Vault eTMF’s philosophy is that the TMF should be “always inspection ready”, meaning completeness is maintained at ~100% on an ongoing basis (Link). The system aids this by making missing documents highly visible and even allowing what are called placeholders or expected document records. Users can generate an Expected Document List which basically creates placeholder records for each expected artifact for a study milestone. If some are not applicable, they can mark them as not applicable or provide a reason. This way, the TMF has either a document or a documented rationale for each expected item. Vault can also be configured to send reminders or escalate if certain important documents haven’t been provided by a certain time (for example, if 30 days after site initiation the site’s IRB approval is still not filed, that could trigger a notification to the study lead).

Finally, Vault eTMF’s automated checks extend to things like duplicate detection and naming standard enforcement. While a bit lower-level, these help maintain quality by preventing common TMF issues (like duplicate copies of the same document being filed in different places, or documents missing identifiers). The system can be set to detect if a file identical to one already in the TMF is being uploaded again, and warn the user. It also can generate a unique document ID and enforce templates for document titles to ensure consistency. All these little features reduce clutter and improve the signal-to-noise ratio in the TMF, which in quality terms means a cleaner, more reviewable TMF.

In conclusion, Vault eTMF not only stores TMF documents, it actively monitors and drives quality and completeness. Through dashboards like the TMF Homepage (TMF Homepage (eTMF) | Vault Help), study teams get immediate feedback on the state of their TMF – what’s missing, what’s outstanding for approval, how timely documents are being filed, etc. Through automated workflows and logs, quality control is embedded in the process, ensuring issues are caught and resolved systematically. This approach turns what used to be a reactive exercise (fixing the TMF at the end) into a proactive continuous quality management practice, greatly reducing the risk of inspection findings and ensuring the TMF truly reflects the trial conduct at all times (Link).

Audit Trails, Electronic Signatures, and Inspection Readiness

Auditability is a fundamental requirement of any eTMF, and Vault eTMF provides comprehensive audit trail capabilities to record every user action and document event. For each document (and indeed each object record like a Study or an Artifact), Vault maintains an audit trail that captures who performed what action and when, along with any changes in values (Link). This includes events such as document uploads, edits (metadata changes or new versions), workflow actions (like approvals or rejections), permission changes, and deletions or archival. The audit log entry will typically include the date/time, the user’s name, the event (e.g. “Entered Steady State – Approved”, “Field X changed from A to B”), and, when applicable, the reason (for example, for a document deletion, the system forces selection of a reason which is logged) (Link). These audit trails are immutable – users (even admins) cannot modify or delete audit entries. This immutability is critical for compliance; it ensures an inspector can trust that the audit trail is a true, untampered record of system activities (a requirement under 21 CFR Part 11’s mandate for secure, computer-generated audit trails). Vault provides UI screens to view audit trails and also allows exporting them (for instance, exporting the audit log of an entire study’s documents in preparation for an inspection). The audit trail data is extensive enough to reconstruct who had accessed a document and whether any changes were made. If, for example, someone questions when a certain document was provided to the TMF, the audit trail will show the exact timestamp it was uploaded and by whom. If a document’s metadata was updated (say its classification was corrected), the before/after values and timestamp are logged (Link).

In addition to per-record audit logs, Vault eTMF also logs user access events (login attempts, etc.) and system configuration changes in separate audit trails. This is important during inspections to show the overall security of the system – e.g., one can produce logs of all user login attempts (with dates and IP addresses) to show there was no unauthorized access, or logs of configuration changes to show that no one altered the system configuration without proper oversight. Veeva’s internal procedures log administrative changes to the vault environment as well, and all these can be made available during audits if needed.

Electronic signatures in Vault eTMF are tightly integrated with audit trails. When a user e-signs a document (usually as part of an approval or QC workflow), the signature event is written to the audit trail with the meaning of the signature (e.g. “Approved” or “Verified”) and the signature manifestation is attached to the document. Vault’s platform includes robust e-signature functionality meeting the criteria of FDA Part 11 and EU Annex 11. Each signature requires the user’s unique credentials and is linked to their identity; Vault automatically appends the user’s full name, timestamp, and the meaning to the document. For instance, an approved document might have an appended page that states “Electronically signed by John Smith on 2025-03-31 10:45:23 PST (Approval of document)”. This signature page becomes part of the PDF rendition in the vault, ensuring that if the document is printed or viewed, the signature is evident. The system also prevents someone from altering a document after it’s been signed without invalidating that signature (any new version would require a new round of approvals).

From an inspection readiness perspective, these audit trails and signature features are invaluable. During a regulatory inspection or an internal audit, an inspector often asks to see evidence of who did what and when. With Vault eTMF, an inspector can be given read-only access to the system with an Auditor role (Link), allowing them to navigate the TMF themselves. They can look at any document and view its audit trail and signatures directly in the system, which provides a very high level of transparency. (In fact, Veeva notes that auditors have a dedicated role that gives easy online access, highlighting that you don’t need to produce everything on paper (Link).) This means no scrambling to pull logs or assemble files – the live system is inspection-ready. If an inspector prefers offline review, Vault can export documents along with an Audit Trail Report for each, but increasingly inspectors are becoming comfortable with direct system access.

Vault eTMF’s focus on inspection readiness goes beyond just having logs – it’s about having the TMF complete, well-organized, and readily accessible at any time (Link). Thanks to the completeness tracking and ongoing quality checks described earlier, by the time an inspection occurs there should be few if any missing documents or loose ends. The fact that everything is electronic and centralized means that finding any given document or piece of evidence is fast (just a keyword search or browsing the TMF structure). The TMF Homepage and reports can be used in preparation to demonstrate to inspectors, for example, a list of all expected documents and their status. Additionally, Vault’s ability to produce certified copies (if original wet-ink paper documents were scanned in, Vault eTMF can store them as certified copies with an attestation) ensures inspectors accept the electronic versions as official.

It’s also worth noting that Vault eTMF supports blinding and unblinding processes which are sometimes examined during inspections (to ensure that blinded personnel did not have access to unblinded data prematurely). As mentioned, Vault can restrict unblinded documents and even has a feature to allow controlled unblinding (for instance, if an interim analysis requires unblinding certain individuals, Vault’s permissions can be adjusted and all such access is logged). An inspector could verify via audit logs that no unauthorized person accessed the unblinded documents before the appropriate milestone.

Another critical inspection aspect is demonstrating system security and integrity. Inspectors may ask how you know that the records in the eTMF are protected from alteration or loss. Here, Vault’s technical safeguards – encryption, permission controls, daily backups – combined with audit trails – provide the answer. For instance, the audit trail will show if anyone attempted to delete a document (and if they did, who approved that and why, as deletion can be configured to require electronic signature approval too). Vault also has a concept of document locking/finalization where after a study is archived, the TMF can be locked (no further changes), which is often done at study close-out to create a final archive for the inspector. That event (locking the TMF) is audited as well, showing that after that point, only read access was allowed.

In essence, Vault eTMF gives sponsors and CROs the tools to always be inspection-ready, not just reactively but by design. Every document has its provenance recorded, every approval has a name and date, and every missing item is flagged ahead of time. During an inspection, the audit trails and e-signatures provide irrefutable evidence of compliance with procedures and regulatory requirements (e.g. demonstrating that the appropriate person approved a procedure and that it was done on time). This level of detail often impresses inspectors because it shows a level of control and oversight difficult to achieve with paper. As an example of readiness, a sponsor using Vault eTMF can easily produce a report of all protocol amendments and show the approval signatures and dates for each, and the audit log would show that investigators were notified via Vault (if using a distribution workflow) – all within minutes. This ability to retrieve answers quickly can significantly smooth the inspection process.

Finally, beyond regulatory inspections, the robust audit trails and signature compliance give confidence to the organization internally. They can perform their own audits or respond to partner audits knowing the system tracks everything. It reduces ambiguity and disputes (e.g. if a CRO says “we uploaded that file on time” but sponsor can’t find it – the audit trail can resolve if it was ever uploaded and if so when and by whom). It also helps in root cause analyses if there was a quality issue – you can trace back through the logs to see what happened. In summary, Vault eTMF’s audit trail and e-signature functionalities are comprehensive and fully integrated, serving as the foundation for trust in the eTMF’s content. Coupled with the system’s features that keep the TMF complete and current, they ensure that at any moment, the TMF can withstand the scrutiny of an inspection, fulfilling the promise of constant inspection readiness (Link).

Security Architecture (Encryption, Identity Management, and Logging)

Veeva Vault eTMF is built with a defense-in-depth security architecture to protect sensitive clinical data. This spans data encryption, network security, identity and access management, and extensive logging and monitoring. At the core, all data in Vault eTMF is encrypted both in transit and at rest. Data in motion (between the user’s browser and the Vault servers) is protected using TLS (Transport Layer Security) with strong encryption ciphers (at minimum 128-bit AES for the session, using 2048-bit RSA/SHA-256 certificates) (Link). This ensures that all interactions (logins, document uploads/downloads, API calls) are secure from eavesdropping or man-in-the-middle attacks. On the server side, data at rest is encrypted using industry-standard AES encryption. Document files stored in the Vault file store are encrypted with AES-128, and since these files are also persisted in AWS S3 storage, an additional layer of AES-256 encryption is applied by AWS on the S3 side (Link). In effect, documents enjoy multi-layer encryption. The database storing metadata is on encrypted volumes as well, and certain sensitive fields (like passwords or tokens) are one-way hashed or encrypted in the database. By encrypting content at rest, Veeva satisfies requirements for open cloud systems (21 CFR Part 11 open system controls) and greatly reduces the risk of data exposure even if infrastructure were compromised.

Identity management in Vault eTMF is flexible yet secure. For authentication, as noted, Vault can integrate with enterprise Single Sign-On. In an SSO setup, Vault delegates user authentication to the customer’s Identity Provider (IdP) via SAML 2.0 (Vault Integrations). This means users log in with corporate credentials (often with multi-factor authentication enforced by the IdP), and Vault trusts the SAML assertion to log the user in. This arrangement has several benefits: password policies and 2FA can be managed by the corporation, and Vault doesn’t store those passwords (limiting liability). For API integrations and for scenarios without SSO, Vault supports username/password with strong internal controls (configurable complexity rules, password expiration, account lockout on failed attempts) (Link). As an extra layer, Vault can integrate with OAuth2/OpenID Connect for token-based auth, which is useful for headless integrations where an API user can obtain a temporary token rather than handling a password (Vault Integrations).

Vault eTMF issues secure sessions once a user is authenticated. Each session is tracked with a session cookie that is tied to that user and device, with a configurable timeout to automatically log users out after inactivity (Link). The session cookies are marked secure and use random hashes, and Vault employs protection against common web threats like CSRF (Cross-Site Request Forgery) by using synchronizer tokens (Link). In practical terms, once a user logs in, their session is valid for a set duration (say 30 minutes of inactivity) after which they must log in again, preventing stale sessions from being misused. All login attempts (successful or failed) are logged, providing an audit trail of authentication events (Link). Passwords, if used, are never stored in clear text – Vault uses salted hashing (with multiple iterations) to irreversibly store passwords (Link), meaning even in the unlikely event of database access, original passwords cannot be retrieved. These measures align with OWASP best practices and regulatory expectations (Annex 11 expects appropriate user authentication and session controls, which these fulfill).

On the authorization side, as discussed in the RBAC section, Vault eTMF implements a robust permission model. From a security architecture perspective, this is enforced by the application on every request: when a user attempts to access a document or perform an action, the application server checks the user’s roles and the object’s security settings (down to the field level if needed) before allowing it. This is built into the platform’s core code. There’s also an additional concept of “atomic security” where the system ensures that each individual record’s permissions are isolated – one study’s documents cannot be seen by users not associated with that study, etc., because the queries themselves filter based on the user’s access scope (Link). This prevents any chance of cross-study data leakage in a multi-tenant vault containing multiple studies or programs.

From an infrastructure security standpoint, Veeva hosts Vault in secure, Tier 4 data centers (mostly via AWS). The data centers and cloud environment are certified for high security standards (ISO 27001, SOC 2, etc.), and Veeva manages the environment following documented SOPs. The network is protected by firewalls and intrusion detection systems. Only necessary ports are open (HTTPS for the app, maybe SFTP for certain data loads, etc.), reducing attack surface. Within the cloud, each customer’s data is logically separated, and even within a Vault, the data for different Vaults is segregated by tenant identifiers at the database level. Veeva’s cloud operations team monitors the system 24/7, with alerts for unusual activities or performance anomalies.

All interactions and critical operations are logged. Aside from audit trails for business data, the system produces application logs, access logs, and system logs that Veeva monitors for security events. For instance, logs are reviewed for multiple failed login attempts (could indicate a brute force attack), or unusual API usage patterns. Veeva likely employs SIEM (Security Information and Event Management) tools to aggregate and analyze logs for threats. The company being ISO 27001 certified means they have processes for regular risk assessments, vulnerability scanning, and penetration testing (Link). Patches to the infrastructure or application for security vulnerabilities are deployed as needed (and because it’s SaaS, customers get the benefit of immediate patching without having to do it themselves). Vault also has built-in virus scanning for file uploads – documents added to eTMF are scanned for malware to ensure a user doesn’t inadvertently introduce an infected file.

Another aspect is encryption key management – Veeva manages encryption keys carefully, likely with AWS Key Management Services and strict access control so that only essential automated processes can access keys (even Veeva personnel wouldn’t directly handle encryption keys, it’s programmatic). Backups containing encrypted data are also encrypted, maintaining protection.

Physical security is addressed by hosting in AWS data centers which have robust physical controls (guards, biometrics, etc.), but Veeva’s technical security whitepapers (like the SiteVault one) emphasize that even if someone had physical access to a disk, the data is encrypted and would not be accessible (Link) (Link).

In summary, the security architecture of Vault eTMF is multi-layered:

• Network/Transport Layer: TLS for all client-server communication (Link).
• Application/Data Layer: Role-based access, object-level security, audit trails for all operations (Link) (Link).
• Encryption: AES-128/AES-256 encryption for all stored content and database encryption, safeguarding data at rest (Link).
• Authentication: Integration with SSO or strong internal auth, salted hash for passwords, session management with timeouts (Link) (Link).
• Logging/Monitoring: Detailed logs of access and changes, monitored by security team for anomalies.
• Processes/Compliance: Regular audits, ISO 27001 certification, adherence to Part 11, Annex 11 security expectations (Link) (Link).

These controls not only protect the confidentiality of trial data but also its integrity and availability (which are equally important – ensuring data isn’t altered improperly, and that it’s accessible when needed). In a clinical trial context, data security is critical not just for patient privacy (GDPR) but also for maintaining the trustworthiness of trial evidence. Vault eTMF’s security measures ensure that sponsors and sites can confidently use the system without risking data leaks or loss. It’s worth noting that Veeva’s commitment to security is evidenced by their certifications and the fact that they undergo hundreds of customer audits, as mentioned in their whitepapers (Link) – passing those means they meet or exceed the security requirements of some of the most stringent pharma companies and their IT departments.

Reporting and Dashboard Capabilities

One of the strengths of Veeva Vault eTMF is its built-in reporting and analytics engine that allows users to gain insights into TMF status, content, and process performance. The system provides both out-of-the-box reports/dashboards (tailored for TMF use cases) and tools to configure custom reports. At the highest level is the TMF Dashboard (Homepage) which we have discussed: it visually summarizes key metrics like completeness, timeliness, open tasks, upcoming milestones, etc., in real-time charts and lists (TMF Homepage (eTMF) | Vault Help). This dashboard is interactive – clicking on a widget drills into the underlying data (for example, clicking on the number of “Unapproved Documents” opens a filtered list of those specific documents). This allows users and managers to quickly navigate from a metric to the actual records that need attention, facilitating prompt action.

Beyond the dashboard, Vault eTMF offers a versatile ad-hoc reporting module. Users with the proper permissions can create reports on essentially any object or artifact in the system. For instance, one could create a report of “All documents by Study and Country, showing Document Type, Status, and Last Modified Date”, or a report of “Expected Documents not yet filed for Study X”, or “All Protocol Deviations logged (if those are tracked as objects)”. Reports can span multiple objects via joins – since Vault is also managing study-level data (like milestones, country, site info), you can report on documents in context, e.g., “Site Initiation Documents vs. date site was activated” to see if filings were timely. The reporting interface is point-and-click: choose the object (Documents, Studies, etc.), choose filters, choose columns, and the system will generate the report. These reports can be in tabular format, summary (pivot) format, or displayed as charts (pie, bar, line charts). For example, a user could generate a bar chart report of “Documents count by category for Study XYZ” to visualize which categories have the most documents.

Reports can be saved and shared with others in the organization. Vault eTMF also supports dashboard assembly, where multiple reports or charts can be placed together on a single page (this is how the TMF Homepage is constructed under the hood – it’s essentially a pre-configured dashboard of specific reports). Users can create their own dashboard pages with the reports relevant to them. For instance, a TMF Manager might create a dashboard that has one section showing completeness by study, another showing documents awaiting quality check, and another listing any documents approaching expiry (if relevant). This can all be done without any external BI tool – it’s all native to Vault.

The platform includes some pre-built reports specifically designed for TMF operations. These might include reports like “TMF Completeness by Artifact”, “Documents Expiring in next 30 days” (if tracking expiry of things like IRB approvals), “Open Quality Issues”, “Signature Pending Workflows”, etc. Additionally, because Vault eTMF can manage milestones and expected docs, there are likely reports correlating those – such as a report listing each milestone and whether the expected docs for it are complete.

A powerful feature is the ability to export reports and even use Excel templates for formatting. Vault allows users to export report results to CSV or Excel. With Excel, Veeva provides an option to use a pre-formatted Excel template that can include pivot tables, macros, or specific layouts (Veeva Vault Platform | Veeva). When the report data is exported, it can populate that template. This is useful if an organization has a standardized Excel-based report or metric sheet they want to generate from the system. For example, one could have an Excel template for an “Inspection Readiness Report” that expects certain fields, and Vault can fill it with the live data upon export. This saves time compared to manually cobbling data together outside the system.

Vault eTMF’s reporting engine also covers user and activity metrics. Admins can report on usage, like how many documents each user has uploaded, or how long on average it takes for a document to go from draft to approved (since all dates are in the system, this can be calculated). The earlier-mentioned Timeliness widget is essentially a specialized report on document approval times (TMF Homepage (eTMF) | Vault Help). Similarly, “Tasks Requiring Attention” is effectively a report on open workflow tasks by due date (TMF Homepage (eTMF) | Vault Help). And “Upcoming Milestones” is a report on milestone records without actual finish dates (TMF Homepage (eTMF) | Vault Help).

Another facet is search analytics – while not exactly reporting, the system’s global search provides facets and counts (like how many documents meet certain criteria) which can be a quick form of ad-hoc query. But for formal reporting, the report builder suffices.

Crucially, all these reports and dashboards are live – they query the current data in real time. So if a missing document gets filed, a refresh of the completeness report will reflect that immediately, turning a red indicator to green, for example. This immediacy contributes to the “active TMF” concept, where metrics are continuously updated and available. Users don’t have to manually compile status reports; they can simply open Vault and see the status.

For archival or audit purposes, Vault eTMF also allows exporting a snapshot of the TMF index and content listings. One might export a report of all documents with their metadata to serve as an official TMF inventory at a point in time (for instance, at study close). That, combined with the ability to export the files themselves (if needed for an inspector or as an archive copy), means the entire TMF can be programmatically listed and packaged.

In terms of permissions, report visibility is controlled by the same security as everything else – if a user doesn’t have access to certain documents, even a report that includes them will either exclude those records or aggregate them in a way that doesn’t expose unauthorized info. For example, an auditor given access to one study could run a report but they’d only see data for that study. This is important for multi-study environments to ensure confidentiality across projects.

The reporting and dashboard capabilities of Vault eTMF allow teams to move beyond reactive document tracking to data-driven TMF management. With trends and metrics at their fingertips, they can identify areas of improvement (maybe one study has a lower completeness percentage than others – indicating that team needs support or training). They can celebrate positive metrics (like 100% of documents filed within 5 days of generation). And during governance meetings, instead of anecdotal updates, the team can look at live dashboards from Vault to inform decisions. Having these capabilities baked into the eTMF system eliminates the need to export data to external tools for analysis in most cases, which means fewer manual steps and more reliable, up-to-date information. In regulated environments, using the validated system for reporting also means those reports are considered trustworthy and can be used as evidence of compliance.

In conclusion, Vault eTMF doesn’t just store content – it turns TMF management into a measurable, monitorable process. Built-in reports and dashboards offer instant visibility into the state of the TMF and related processes (eTMF Overview | Vault Help). This transparency drives better oversight (sponsors can easily see CRO performance on TMF completeness, for example) and helps avoid surprises. In a world where inspection readiness is critical, the ability to generate a complete TMF status report with a few clicks is a major advantage, and Veeva has made that a central feature of their eTMF.

Cloud Deployment and Validated Infrastructure

Veeva Vault eTMF is provided as a cloud Software-as-a-Service (SaaS) application, which relieves customers of the burden of managing servers or installing software, while also introducing a shared responsibility for maintaining a validated state. Veeva’s cloud deployment model involves hosting Vault eTMF on robust infrastructure (primarily Amazon Web Services) and delivering it through multiple PODs (Points of Delivery) as previously mentioned. Each POD is effectively an application cluster in a given region that serves a set of customers (Veeva Vault POD Details | Veeva Vault Release Notes). Veeva operates several PODs in the US, Europe, and Asia-Pacific to serve local regions and provide redundancy. For example, a European customer might be hosted on a POD in EU (Germany), whereas an APAC customer might be on a POD in Japan (Veeva Vault POD Details | Veeva Vault Release Notes). This geographic distribution not only helps with latency and data residency, but also plays into disaster recovery.

The deployment architecture emphasizes high availability (HA) and disaster recovery (DR). In AWS, Veeva uses multiple availability zones and regions to ensure that if one data center (or even an entire region) experiences an outage, customer Vaults remain available or can be restored quickly. Data is continuously replicated from the primary data store to a secondary location. According to Veeva’s SiteVault technical whitepaper (which reflects general Vault practices), they have a Recovery Point Objective (RPO) of 4 hours and Recovery Time Objective (RTO) of 24 hours (Link). This means in the worst case of a regional disaster, at most 4 hours of data might be lost (though typically much less, since replication is frequent) and the service would be restored within 24 hours (Link). They achieve this by storing regular backups and utilizing cross-region replication of data (for instance, a Vault in one AWS region is backed up to S3 in another region every night) (Link). Those backups are retained for an extended period (the whitepaper mentions backups stored for 2 years) (Link), which also aids long-term archival needs or recovery from data corruption issues.

From a validated infrastructure perspective, Veeva follows a rigorous process to ensure the environment and application are suitable for GxP use. Each release of Vault eTMF (Veeva typically has 3 major releases a year: e.g., 25R1, 25R2, 25R3 corresponding to year and release number) is tested and validated by Veeva in-house (Veeva Vault Platform | Veeva). They perform IQ (Installation Qualification) and OQ (Operational Qualification) on the base application and provide customers with a Validation Summary Report or a full package that includes test scripts, results, traceability matrix, etc. Customers, as the system owners, typically perform a risk assessment and a PQ (Performance Qualification or User Acceptance Test) focusing on their specific use (especially any configurations or customizations they have) – but Veeva significantly reduces this burden by handling the core testing (Veeva Vault Platform | Veeva). The Vault Platform has a concept of continuous validation, where even configuration changes made by the customer in their vault (like adding a new field or workflow) are done in a controlled, versioned manner that is covered by the platform’s validation approach (there are configuration migration tools and the ability to promote configurations from a sandbox to production with audit logs).

All customers get these updates on a regular schedule. Usually, Veeva offers sandbox preview windows where a customer’s sandbox vault is upgraded first (say a few weeks before production) so they can do any testing. Then the production vault is upgraded in a maintenance window. Because it’s multi-tenant, Veeva can deploy these updates efficiently – often in a matter of a few hours – and all customers on a POD are updated around the same time (with some PODs designated for “Limited Release” where early adopters go first, and others for “General Release” a few weeks later, once any early issues are ironed out) (Veeva Vault POD Details | Veeva Vault Release Notes) (Veeva Vault POD Details | Veeva Vault Release Notes). This approach ensures that all customers are on a uniform version without lag, which is important for compliance (no outdated software running) and supportability. It also means customers benefit from continuous improvements (new features, security patches, etc.) as soon as they are available, rather than waiting for lengthy upgrade projects. The validated state is maintained release to release via documented change control – Veeva provides release notes, impact assessments, and updated validation documents with each release, so customers can assess changes.

The cloud deployment is also tuned for scalability on the infrastructure side. Within each POD, multiple application servers and database nodes share the load. Veeva can scale up the compute power (e.g., add more CPU/RAM to the cluster) or scale out (add more nodes) to handle increased usage. They also utilize AWS capabilities like auto-scaling groups and load balancers to ensure consistent performance. For file content, using S3 means effectively limitless storage scalability – customers don’t have to worry about running out of disk space for their documents. And because S3 is highly durable (designed for 11 nines of durability), the documents are safe even without considering the backup copies.

On the network connectivity side, customers access Vault eTMF via the internet using HTTPS. Veeva likely uses Amazon CloudFront or similar CDN for optimizing delivery of static content (like UI assets), but document download/upload goes directly to the data centers. Companies often whitelist Vault’s URLs or IP ranges for security, and Veeva publishes those details (for example, all vaults might use domains like abc.veevavault.com and IP ranges corresponding to the AWS region). The web application is browser-based and supports modern browsers; there's no heavy bandwidth requirement except when transferring large files. For very large documents, Vault supports chunked transfer so as not to time out.

From a maintenance and support standpoint, Veeva’s cloud model means they handle all the database tuning, indexing, and system optimization behind the scenes. Regular maintenance (like applying OS patches or performing failover tests) is done in scheduled windows, typically with minimal downtime thanks to redundant systems. Veeva communicates these to customers via their trust site or notifications. Many operations can be done with zero downtime (for instance, the databases can be patched via failover to a replica).

Data integrity is protected not just by backups but by transactional integrity in the databases. Vault likely uses an ACID-compliant relational database (such as Oracle or PostgreSQL) which ensures that all transactions (like uploading a document and its metadata) either complete fully or not at all, so you won’t end up with orphaned data even if there’s a crash mid-operation. Also, given it’s a validated environment, Veeva likely restricts direct database changes in production – all changes go through the application logic, which is validated.

In terms of data migration and portability, Veeva provides tools to import and export data as needed, which is relevant in deployment (migrating from a legacy eTMF) or if moving out of Vault. They have Vault Loader for bulk import of documents and metadata, and they can deliver a full data export if a client ever needs all their data (like for transitioning to another system or for an inspection archive). Because everything is in the cloud, customers typically rely on Veeva’s processes for these heavy operations, but they have been done successfully for many companies (migrating millions of documents in or out) ([PDF] Doing data migrations, or system consolidations, or any combination ...).

The validated cloud model of Vault eTMF has been a paradigm shift from traditional on-prem systems. It allows faster innovation (new features delivered thrice yearly) while ensuring compliance (since each release is validated and change-managed). It also means issues can be addressed quickly – if a bug affecting compliance is found, Veeva can patch it across all customers at once, rather than each customer having to implement a fix. This reduces risk in the long run. For companies, the SaaS model means no local installation qualification needed, but it does put onus on them to have vendor qualification and to leverage Veeva’s validation package for their internal validation sign-off.

In conclusion, the cloud deployment of Vault eTMF gives the best of both worlds: the scalability and reliability of a modern cloud service with the validation rigor required for a GxP system. Data is securely hosted and replicated for safety, downtime is minimal and handled by the vendor, and upgrades are seamless and frequent – keeping the system technologically up-to-date and compliant at all times. This allows clinical IT teams to focus less on infrastructure and more on process and content, knowing that Veeva is ensuring the underlying system remains continuously compliant and available.

Data Residency, Retention, and Archival Protocols

Clinical trial data is subject to various regulations around where it is stored, how long it is kept, and how it is archived after trial completion. Veeva Vault eTMF provides capabilities to address data residency requirements and to manage data retention and archival in line with regulatory obligations.

Data Residency: As noted, Vault eTMF can be hosted in multiple jurisdictions. Veeva has deployed data centers/PODs in the United States, Europe, and Asia-Pacific, including specific locations like Germany, the UK, Japan, etc. (Veeva Vault POD Details | Veeva Vault Release Notes). When a customer signs up for Vault eTMF, they can typically choose their primary hosting location (for example, a European sponsor might choose a European POD so that personal data of EU participants remains in EU data centers). Vault’s architecture ensures that all application data (documents and metadata) reside in that chosen region. Veeva’s addition of EU data centers (Germany and UK) was precisely to support the increased demand for EU-only data storage (Veeva Systems Opens New Data Centers in Europe to Support ...). Moreover, even within a region, the data is replicated to a secondary site in the same general region for DR (e.g., within EU, Germany to UK or vice versa) – but this still keeps data within EU borders if that’s a requirement. For Japan, similarly, they have a POD in Japan to keep data local for Japanese compliance needs. This design helps companies comply with regulations like GDPR, which may restrict cross-border data transfers, and with country-specific laws (some countries require that health data or trial data not leave the country). Veeva likely provides documentation or agreements ensuring that data remains in the agreed region and that any transfers (like for support purposes) are done in compliance with privacy laws.

Retention Policies: Sponsors are typically required to retain trial master file documents for a long period post-trial (often at least 25 years per regulations such as EMA’s requirement, or per ICH E6 which says at least 2 years after last approval of a marketing application or longer if required by other rules). Vault eTMF allows data to be kept for as long as needed – there is no forced purge by the system. In terms of functionality, Vault has features for retention and disposition if a customer wants to automate deletion after a certain time. For instance, one could configure a retention policy that marks records for deletion after X years of archival, but given the typical long timelines and the fact that sponsors often want manual control, many just keep the data indefinitely in Vault or export to an archive when needed. The system does have the notion of an Archive state for studies and documents. When a study is completed and all documents finalized, an admin can perform a Study Archival process (eTMF Overview | Vault Help). This essentially flags the study (and its documents) as archived: documents might move to an “Archived” lifecycle state (read-only, no further edits allowed) and the study record is closed. Vault eTMF will still retain all those documents and their audit trails (eTMF Overview | Vault Help), but they can be logically separated from active studies (for example, one might filter them out of everyday search unless specifically looking in archives). Archiving can trigger Vault to also capture an archive package if configured – possibly generating a ZIP of all files and an index, which could be stored offline or in a long-term storage solution if desired. The help references that study archival includes study documents, document audit trails, and related records (eTMF Overview | Vault Help), implying it is a comprehensive preservation of the TMF at the point of archival.

When data reaches end-of-life (say after the required 25 years), a sponsor has options: they can either continue to store it in Vault (since it’s a cloud service, it’s feasible to just keep it, though they’d pay for storage and user licenses if any), or they can export and purge. Vault eTMF does support deletion with reason tracking (and possibly requiring approvals). If a sponsor chooses to purge data, they can do so through a controlled process – for example, deleting a study’s documents after retention time. The system will log the deletion (who, when, reason). Some sponsors might export the entire TMF to a medium like PDFs on encrypted drives to store offline (for compliance) before deleting from the active system. Vault makes it easy to export all documents and metadata if needed for such purposes. On Veeva’s side, if a customer leaves the platform, Veeva can provide a full data extract and then will delete the data from their systems as part of contract termination (ensuring no residual copies remain beyond backup retention periods).

Data Integrity in Archival: Because Vault retains audit trails and electronic signatures even in archived studies, the archived TMF in Vault remains an authentic copy of the TMF that could be shown to inspectors years later. The challenge with long-term digital archiving is format obsolescence – Veeva mitigates that by storing files in common formats (PDF/A for long-term document preservation is likely used for final documents). They also capture the context (the metadata and structure), which is crucial for a TMF. So if you open an archived study in Vault, you still see the hierarchy and metadata as it was, not just a pile of files.

Data Residency for Archives: If needed, Vault could even transfer archives to different regions (e.g., if a sponsor relocates or a regulatory requirement changes, they could migrate a vault’s data to another region, though that would be a project with Veeva’s help). The typical case is simply keeping it where it is.

Another feature related to retention is Legal Hold. If for some reason a legal hold is placed (e.g., litigation related to a study), Vault has a Legal Hold function that ensures documents cannot be deleted until the hold is lifted (Legal Hold Administration | Vault Help). This is important to prevent accidental or policy-driven deletion of records that become subject to investigation or legal scrutiny.

Veeva’s backup retention (2 years as mentioned) means that even if something were accidentally deleted, it might be recoverable from backup for a time. However, recovery from backups in multi-tenant SaaS is not trivial (it would typically be done by restoring a copy of the database and extracting the data). Typically, Veeva might instead rely on the application’s recycle bin features for short-term undo of deletions (Vault does have a concept of a “vault recycle bin” for documents that might allow admin restore within a limited window, but that might depend on configuration).

On the topic of transfers, we covered how TMF Transfer allows moving data between vaults (sponsor/CRO). That also ties into archival: a CRO might archive the TMF in their vault but then transfer it to the sponsor’s vault for the sponsor’s long-term retention.

Certified Copies and Originals: The eTMF may contain certified copies of paper documents. Vault eTMF supports the concept of marking a document as a certified copy of a source document (metadata can capture that). This is relevant because if the original was paper and destroyed, the electronic version in Vault is the one to retain for the regulated period. The system’s audit trail and possible “certified by” fields give confidence that the electronic copy is legally acceptable as the original going forward (per FDA and EMA guidance that certified electronic copies can replace originals).

In practice, sponsors using Vault eTMF often treat it as the system of record even for archived studies, because it’s convenient to retrieve documents years later if needed (say, for a follow-up study or a regulatory submission or inspection). Veeva thus ensures that even over many years, the data will remain accessible – hence their use of durable storage and standard formats.

Data deletion at contract end: Veeva, being a cloud vendor, will have procedures when a customer decommissions a vault. They likely provide all data to the customer and then securely wipe it from their systems. Their ISO compliance and contractual obligations ensure they do this properly (including all backups after expiration). Of course, if a backup is kept 2 years, one could argue data lingers in backups, but Veeva might have ability to exclude certain data from backups or at least ensure it’s not easily accessible.

In summary, Vault eTMF gives customers the flexibility to comply with various retention schedules and residency requirements:

• It allows data to be stored in specific regions to meet local regulations (with multiple global data centers) (Veeva Vault POD Details | Veeva Vault Release Notes).
• It provides features to formally archive a TMF at study close, freezing the content and preserving it with full context (eTMF Overview | Vault Help).
• It does not force purge data, so long retention (decades) in the live system is supported, but also provides options to export or delete when the time comes, under controlled conditions.
• The integrity and retrievability of archived data is maintained, facilitating future audits or regulatory reviews even long after trial completion.

By handling these aspects, Vault eTMF helps sponsors fulfill regulatory requirements such as 21 CFR 312.62(c) (retention of records), EMA’s Directive on document retention, and general good practice of keeping trial records secure yet accessible. The data residency options help with GDPR compliance and with sponsor policies (some companies require that certain data types stay within certain jurisdictions or on approved infrastructure). Veeva’s approach of multiple regional PODs and clear delineation of where data resides addresses that concern proactively, which is a big advantage for global trial management.

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In conclusion, Veeva Vault eTMF’s deeply integrated platform design, encompassing everything from technical architecture to granular functionality, provides clinical trial professionals with a powerful tool to manage TMF content in a compliant, efficient, and proactive manner. By unifying document management with trial process data, automating classification and quality checks, enforcing security and compliance controls, and delivering real-time insights, Vault eTMF enables what Veeva calls an “Active TMF” – one that is always up-to-date and inspection-ready (Link). Its cloud SaaS delivery ensures scalability and continuous improvement, while its rich feature set covers all facets of TMF operations: from architecture and access control to collaboration, integration, and archival. This makes Vault eTMF not just a document repository, but a cornerstone for modern clinical trial management, aligning technology with the operational and regulatory demands of today’s global trials.

Sources: The information in this article is based on Veeva’s official product documentation, whitepapers, and datasheets, which provide detailed insight into Vault eTMF’s capabilities and design (eTMF Overview | Vault Help) (Veeva Vault Platform | Veeva) (Link) (Link), as well as industry regulations and best practices that inform those capabilities. The combination of these authoritative sources ensures a technically accurate and comprehensive overview of Veeva Vault eTMF.