[Recording] How to automate submission content prep. & report generation for content stored in Veeva

This video provides an in-depth exploration of automating content preparation and report generation for regulatory submissions, specifically focusing on content stored within Veeva Vault. The presenter, representing DocShifter, outlines how their platform integrates with Veeva to streamline traditionally manual, slow, and error-prone processes in the pharmaceutical and life sciences industries. The session highlights common challenges such as resource-intensive manual steps, the risk of human error, and the use of overly complex tools for simple tasks, proposing automation as a solution to enhance efficiency and compliance.

The core of the presentation details DocShifter's capabilities as a software solution designed to automate content conversion and enrichment. It emphasizes the platform's ability to integrate with various repositories, including Veeva Vault, SharePoint, and legacy systems, to repurpose and transform content for different use cases. Beyond simple PDF conversion, DocShifter offers advanced functionalities like OCR, applying headers/footers, watermarks, pagination, merging/splitting documents to meet file size limitations, generating detailed bookmarks and tables of contents, managing security, and ensuring compliance with diverse health authority requirements. The discussion also touches upon non-PDF conversions, such as XML, HTML, and refreshing legacy document formats, underscoring the platform's versatility.

A significant portion of the webinar is dedicated to demonstrating specific use cases through workflow automation. These include automatically preparing Microsoft Word content by validating and fixing issues before conversion, rendering submission-ready PDFs simultaneously for multiple global health authorities (e.g., FDA, PMDA, European specs) from a single source, and generating complex reports by leveraging Veeva binders. The platform automates the merging of documents, creation of cover pages, tables of contents, and pagination, all while ensuring full health authority compliance. Furthermore, the video showcases automated PDF validation, which checks generated PDFs against predefined requirements for bookmarks, hyperlinks, fonts, and other technical specifications, with the capability to report issues or automatically fix them. Additional use cases like content migration, archival preparation (PDF/A), and automated email processing are also briefly covered, illustrating the broad applicability of the platform in a regulated environment.

Key Takeaways:

• Addressing Manual Inefficiencies in Regulatory Operations: The video highlights that traditional content preparation and report generation for regulatory submissions are often slow, resource-intensive, and prone to human error due to manual steps. Automation, particularly when integrated with platforms like Veeva, can significantly mitigate these challenges.
• DocShifter as a Comprehensive Automation Platform: DocShifter is presented as a versatile software solution that automates not only content conversion (e.g., to PDF) but also its enrichment and preparation for various use cases across the enterprise, integrating with major content repositories like Veeva Vault and SharePoint.
• Automated Word Content Preparation (Doc Validator): The platform includes a "Doc Validator" feature that can automatically check Microsoft Word documents for errors, report identified issues, or even fix them directly. This pre-processing step helps ensure source document quality before conversion, reducing manual QA/QC efforts.
• Simultaneous Multi-Region PDF Rendition: A key benefit is the ability to generate multiple, health authority-compliant PDF renditions (e.g., for FDA, PMDA, EMA, Swissmedic, Health Canada) simultaneously from a single source document. This is crucial for global submissions, allowing for region-specific nuances in PDF specifications based on metadata.
• Automated Report Generation from Veeva Binders: The platform can leverage Veeva binders (or similar structures) to automatically compile complex reports. Users only need to define the content within the binder, and the system handles merging documents, adding cover pages, tables of contents, pagination, and ensuring compliance, eliminating the need for complex publishing tools.
• Comprehensive PDF Validation: Post-conversion, PDFs can be automatically validated against specific health authority requirements for elements like bookmarks, hyperlinks, font embedding, security settings, and file size. The system can report non-compliance or automatically apply fixes where possible.
• Metadata-Driven Workflows: Automation is driven by configurable workflows that leverage metadata from Veeva Vault. This allows for conditional processing, routing content based on document type, status, or regional requirements, ensuring tailored and compliant output without manual intervention.
• Beyond PDF Conversion: While heavily focused on PDF, the platform also supports conversions to other formats like XML, HTML, and modernizing legacy document types (e.g., DOC to DOCX). It can also handle image, audio, and video format conversions, expanding its utility.
• Support for Content Migration and Archival: DocShifter workflows can facilitate content migration between different repositories (e.g., SharePoint to Veeva) and prepare documents for long-term archival by converting them to formats like PDF/A.
• Automated Email Processing: The platform can connect to email repositories to capture correspondences and attachments, convert them into readable formats, and store them in Veeva or other designated locations, streamlining the management of critical communications.
• Reduced Training Burden and Risk: By automating complex and repetitive tasks, the solution aims to reduce the need for extensive training on multiple complex tools and minimizes the risk of human error inherent in manual processes.

Tools/Resources Mentioned:

• DocShifter: The primary software platform for content automation and rendering.
• Veeva Vault: The main content repository and management system that DocShifter integrates with.
• Microsoft Word: Source document format for content preparation and validation.
• PDF: The primary output format, with a focus on health authority compliance.
• SharePoint, Documentum, Cara: Other content repositories mentioned as being compatible with DocShifter.
• Acrobat: Mentioned as a tool for viewing PDF reports.

Key Concepts:

• Rendition: A converted version of a document, typically a PDF, prepared for a specific purpose like regulatory submission.
• Health Authority Compliance: Adherence to the specific technical and content requirements set by regulatory bodies (e.g., FDA, EMA, PMDA) for submission documents.
• Veeva Binders: A feature within Veeva Vault that allows users to group multiple documents together, often used for compiling reports or submissions.
• Metadata-driven Workflows: Automated processes that use document attributes and properties (metadata) to make decisions about how content should be processed, converted, or routed.
• PDF/A: An ISO-standardized version of the Portable Document Format (PDF) for archiving and long-term preservation of electronic documents.
• OCR (Optical Character Recognition): Technology that enables conversion of different types of documents, such as scanned paper documents, into editable and searchable data.