IntuitionLabs
TrackWise GxP validation and 21 CFR Part 11 compliance services for pharmaceutical quality management

TrackWise GxP Validation & Compliance

21 CFR Part 11, EU Annex 11, and GAMP 5 validation for TrackWise Digital and classic TrackWise QMS. IQ/OQ/PQ, data integrity, and periodic review — built to pass FDA, EMA, and MHRA inspection from day one.

Our TrackWise Compliance Services

We validate TrackWise and TrackWise Digital deployments under GAMP 5 Second Edition with full 21 CFR Part 11 and EU Annex 11 traceability, data integrity controls, and interface validation — plus ongoing periodic review for validated systems.

Validation
Full IQ/OQ/PQ Package
Templated and client-customized User Requirements Specification, Functional Specification, Configuration Specification, Risk Assessment, IQ/OQ/PQ protocols, Traceability Matrix, and Validation Summary Report — all aligned with GAMP 5 Second Edition.
Plan your validation
Compliance
21 CFR Part 11 & Annex 11 Mapping
Explicit clause-by-clause traceability from 21 CFR Part 11 and EU Annex 11 to TrackWise Digital configuration, controls, and SOPs — so every regulator question has a documented answer.
Review our mapping
Data Integrity
ALCOA+ & Interface Validation
Data integrity gap assessments, audit trail configuration, interface validation (SAP, LIMS, MES), and periodic review aligned with MHRA, FDA, and PIC/S PI 041 data integrity guidance.
See Part 11 services

GAMP 5 Second Edition Validation

We validate TrackWise and TrackWise Digital deployments under ISPE GAMP 5 Second Edition, which explicitly addresses modern topics including cloud SaaS, AI and machine learning, and agile delivery. TrackWise Digital is classified as a Category 4 configured product for standard module configuration and Category 5 for any custom Apex, Flow, or Lightning components. Our templated validation deliverables have been refined across dozens of pharma QMS engagements and cut validation timelines by 30 to 50 percent versus from-scratch authoring.

GAMP 5 Second Edition validation methodology applied to TrackWise Digital QMS deployments

21 CFR Part 11 End-to-End

21 CFR Part 11 compliance is not a checkbox — it is a specific configuration of authentication, authorization, audit trail, e-signature, and record retention controls, plus SOPs that govern how users interact with the system. We build a Part 11 Assessment that maps every clause to specific TrackWise Digital configuration, controls, and SOPs. Every assessment survives regulatory inspection and provides the traceability regulators increasingly expect in FDA inspections.

21 CFR Part 11 compliance mapping and controls for TrackWise Digital QMS

Data Integrity That Withstands Inspection

Data integrity is the defining regulatory theme of the last decade — MHRA, FDA, and PIC/S PI 041 data integrity guide have raised the bar. We configure TrackWise Digital audit trails, e-signatures, and access controls to meet ALCOA+ principles, harden interfaces against data loss and tampering, and build the documentation that proves it to regulators.

Data integrity controls and ALCOA+ compliance for TrackWise Digital quality management

Our Validation Deliverables for TrackWise

User Requirements Specification

GxP-aligned URS capturing quality process requirements, regulatory expectations, integration needs, and performance criteria — the anchor document for every downstream validation deliverable.

Discuss your URS

Functional & Configuration Specs

Functional Specification describing what the system does; Configuration Specification describing the specific TrackWise Digital configuration — object fields, workflows, validation rules, Apex, Flow — that delivers the FS.

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Risk Assessment

GAMP 5 risk-based assessment covering functional risk, GxP impact, data integrity risk, and AI-specific risk for any AI-enhanced workflows — with mitigation strategies traced into test protocols.

See AI risk model

IQ/OQ/PQ Test Protocols

Templated test protocols covering installation, operational, and performance qualification with pharma-specific test cases — customized to each client configuration and executed under formal test management.

Review test approach

Traceability Matrix

Complete requirement-to-test traceability matrix showing URS → FS → CS → test case coverage — the single artifact regulators use to verify validation completeness during inspection.

See traceability model

Validation Summary Report

Executive validation summary documenting all deliverables, test results, open deviations, residual risk, and the formal decision that the system is released for GxP use.

Plan your VSR

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Salesforce Release Management Under GxP

TrackWise Digital runs on Salesforce, which releases three times per year. Every seasonal release must be assessed for GxP impact against the validated configuration. We define a structured release management process — release-note impact assessment, sandbox regression testing, managed-package compatibility check with Honeywell, and formal change control documentation. For features that could materially affect validated behavior, we plan phased adoption with re-validation. This disciplined approach is increasingly scrutinized in FDA inspections of SaaS QMS deployments.

Salesforce seasonal release management and GxP change control for TrackWise Digital deployments

Interface Validation for Every Connection

Every integration into or out of TrackWise Digital requires its own validation treatment. We produce an Interface Specification, Risk Assessment, Test Protocol, and Validation Summary Report for each interface. Connections to SAP S/4HANA, LabWare LIMS, MES platforms like Opcenter Execution Pharma, and document platforms like Veeva Vault are validated end-to-end with reconciliation controls and monitoring built in.

Validated interface architecture connecting TrackWise Digital to SAP, LIMS, MES, and document systems

Periodic Review as a Service

Validated systems require periodic review under EU Annex 11 and GAMP 5. We offer periodic review as a managed service — annual (or more frequent) configuration drift assessment, audit trail sampling, access control review, incident history evaluation, and Salesforce release impact summary — producing a Periodic Review Report that joins the permanent validation record.

Periodic review managed service for validated TrackWise Digital deployments under EU Annex 11 and GAMP 5

Frameworks We Follow

📘

ISPE GAMP 5 Second Edition

The industry standard for validating GxP computerised systems, covering configured products, custom applications, cloud SaaS, and AI/ML. Every TrackWise engagement uses GAMP 5 as the core methodology.

⚖️

21 CFR Part 11

FDA regulation for electronic records and electronic signatures in GxP processes. Our validation package maps every Part 11 clause to specific TrackWise configuration and SOPs.

🇪🇺

EU Annex 11

European computerised systems requirements covering risk management, validation, data, audit trails, change control, periodic evaluation, security, and business continuity.

🔐

MHRA Data Integrity

The most prescriptive GxP data integrity guidance, widely adopted globally. Our audit trail, access control, and interface designs follow MHRA principles and ALCOA+.

📗

ICH Q9, Q10, Q12

The pharmaceutical quality system, risk management, and post-approval change management guidelines that define how TrackWise modules should be configured.

🌍

PIC/S PI 041

The Pharmaceutical Inspection Co-operation Scheme data integrity guide, increasingly the de-facto international inspection standard.

Our TrackWise Validation Methodology

IntuitionLabs delivers TrackWise validation with a structured three-phase methodology that produces regulator-ready documentation while minimizing schedule impact on the underlying implementation project. Every deliverable is reusable across sites and produces a clean audit trail.

Validation Planning

Validation strategy, risk assessment, URS development, and test approach — typically 3 to 5 weeks alongside implementation.

Execute IQ/OQ/PQ

Templated protocols executed in validation environments, with formal test management, deviation handling, and traceability.

Report & Release

Validation Summary Report, formal GxP release, and handover to ongoing periodic review and change control.

Frequently Asked Questions

21 CFR Part 11 is the FDA regulation governing electronic records and electronic signatures used in GxP processes. For TrackWise Digital, compliance requires that every quality record — deviations, CAPAs, change controls, audits, complaints — is captured, retained, and retrievable in a way that is attributable, legible, contemporaneous, original, and accurate (ALCOA+). Technical requirements include tamper-evident audit trails, secure user authentication, role-based access control with enforced segregation of duties, electronic signatures with identity and meaning, and time-stamped record history. TrackWise Digital provides these controls natively through the Salesforce Platform, but compliance requires specific configuration, SOPs, and a validation package. IntuitionLabs maps every Part 11 clause to a specific TrackWise configuration, control, or SOP, and documents that mapping as part of our validation deliverables.
EU Annex 11 governs computerised systems used in GMP-regulated operations in the European Union and covers risk management, personnel, suppliers, validation, data, accuracy checks, data storage, printouts, audit trails, change and configuration management, periodic evaluation, security, incident management, electronic signatures, batch release, business continuity, and archiving. TrackWise Digital provides the technical controls to satisfy these expectations, but compliance depends on a risk-based configuration of the platform plus supporting SOPs for change control, periodic review, and incident management. IntuitionLabs builds Annex 11 compliance as a first-class output of our validation work, with explicit traceability from each clause to TrackWise configuration and SOP. We also align with PMDA (Japan), TGA (Australia), and WHO computerised systems expectations for multi-market organizations.
ISPE GAMP 5 Second Edition is the industry standard methodology for validating GxP computerised systems. It classifies systems into categories — from infrastructure software (Category 1) through configured products like TrackWise (Category 4) and custom applications (Category 5) — and applies a proportionate, risk-based approach to validation. For TrackWise Digital, the typical classification is Category 4 for standard module configuration and Category 5 for any custom Apex, Flow, or Lightning components. IntuitionLabs builds a complete validation package including User Requirements Specification (URS), Functional Specification (FS), Configuration Specification (CS), Risk Assessment, IQ/OQ/PQ test protocols, Traceability Matrix, and a Validation Summary Report. Every deliverable is designed to survive FDA inspection and is reusable across sites in multi-affiliate rollouts.
Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ) form the core of a TrackWise validation package. IQ verifies that the system is correctly installed and configured in the target environment — for TrackWise Digital, this means the right Salesforce org configuration, correct user licenses, correct managed package version, and successful connection to integrated systems. OQ verifies that the system operates as specified — running through test cases that cover each module's core workflows (deviation, CAPA, change control, audit, complaint, supplier quality) with specific test data and expected outputs. PQ verifies that the system performs correctly under real-world conditions with real users and real data volumes — typically run as a structured UAT with quality professionals executing production-like scenarios. IntuitionLabs uses templated IQ/OQ/PQ protocols with pharma-specific test cases that we customize to each client's configuration, dramatically reducing validation effort without compromising rigor.
Data integrity is the through-line of modern regulatory expectations under MHRA GxP data integrity guidance, FDA data integrity guidance, and the PIC/S PI 041 data integrity guide. The principles are summarized by ALCOA+ (Attributable, Legible, Contemporaneous, Original, Accurate, plus Complete, Consistent, Enduring, Available). For TrackWise Digital, we configure audit trails that capture every field change with user, timestamp, and before/after values; enforce segregation of duties so that creators cannot approve their own records; disable field-level mass update and API operations that bypass audit; and lock down Salesforce-level administrative permissions. For integrations to SAP, LIMS, and MES, every interface is designed as a reconcilable, auditable pipeline with exception handling and monitoring.
A legacy TrackWise to TrackWise Digital migration is effectively a re-implementation with data carryover, and the validation approach follows GAMP 5 change management principles. We document the legacy configuration and the target Digital configuration, perform a gap analysis to identify workflow and data differences, design a migration approach that preserves regulatory context, and execute parallel validation that runs both systems on the same test data to confirm equivalence. Historical record migration is validated as a data migration under GAMP 5 with specific controls for record-by-record reconciliation, audit trail preservation or mapping, and go/no-go criteria. The cutover is phased with a formal go-live decision checkpoint that evaluates validation status, training completion, and business readiness. Our migration playbook has been refined across multiple pharma clients and avoids the common pitfalls that regulators flag during post-migration inspections.
TrackWise Digital runs on the Salesforce Platform, which means pharma quality organizations must manage two levels of change: configuration changes they make to their TrackWise Digital org (new fields, workflows, validation rules) and platform-level changes that Salesforce makes via seasonal releases (Spring, Summer, Winter). GAMP 5 requires both categories to be assessed for GxP impact. IntuitionLabs defines a structured Salesforce release management process: pre-release impact assessment against release notes, sandbox regression testing covering validated workflows, managed-package compatibility verification from Honeywell/Sparta, and formal change control documentation under your QMS. For Salesforce features that could materially affect validated behavior (e.g. Lightning migration, significant API changes), we plan phased adoption with full re-validation of impacted workflows. This disciplined approach is something regulators increasingly focus on during cGMP inspections of SaaS-based QMS deployments.
A single-site, single-module validation — for example, deviations and CAPA — typically runs 10 to 14 weeks of focused validation work with a team of two to four consultants, layered over a broader implementation timeline. A full multi-module validation covering deviations, CAPA, change control, audit management, complaints, supplier quality, and training typically runs 16 to 24 weeks. Multi-site rollouts leverage templated validation packages to reduce per-site validation effort by 40 to 60 percent. Cost depends on scope, documentation expectations (some clients require more rigorous documentation than GAMP 5 baseline), and the number of integrated interfaces that require separate interface specifications and validation. We scope validation transparently upfront — no surprise change orders mid-project. IntuitionLabs also offers validation-as-a-service for clients who need ongoing support for periodic review, change-driven re-validation, and Salesforce release assessment.
Yes. Interface validation is often the most complex part of a TrackWise validation package, because a single interface typically spans two validated systems plus the integration middleware. For each interface, we produce an Interface Specification that describes the data flow, transformation rules, error handling, and reconciliation approach; a Risk Assessment that identifies failure modes and mitigations; a Test Protocol with positive, negative, and edge-case test cases; and a Validation Summary Report. Integrations to SAP S/4HANA, LIMS platforms (LabWare, STARLIMS), MES (Opcenter Execution Pharma, PharmaSuite), and document platforms like Veeva Vault are validated end-to-end with traceability back to user requirements, consistent with ISPE best practices.
For medical device manufacturers, TrackWise validation must address 21 CFR Part 820 (soon transitioning to the FDA Quality Management System Regulation, or QMSR, aligned with ISO 13485:2016) and ISO 13485:2016. Part 820 and QMSR require specific documentation and process controls around design controls, CAPA, nonconformance, complaint handling, supplier controls, and change control — all of which map to TrackWise modules. We build validation packages that explicitly map Part 820 / QMSR clauses to TrackWise configuration and SOPs, and we align with ISO 13485 clause numbering for ISO-aligned quality systems. For companies preparing for the FDA QMSR transition (effective Feb 2, 2026, see the Federal Register final rule), we help reconcile existing Part 820 documentation with the new QMSR requirements.
Periodic review is a GAMP 5 and EU Annex 11 requirement: a validated system must be periodically re-evaluated to confirm it remains fit for intended use, that controls are functioning, and that no undocumented changes have been introduced. For TrackWise Digital, we structure periodic review as an annual (or more frequent for high-risk systems) evaluation that covers: configuration drift (has anything changed without change control?), audit trail sampling (spot-check record history for anomalies), access control review (users and permissions remain appropriate), incident history (any unresolved issues with GxP impact?), and Salesforce release impact assessment. The output is a Periodic Review Report that becomes part of the permanent validation record. Clients with small internal validation teams often engage IntuitionLabs as a managed service for periodic review, giving them an independent quality lens on their TrackWise deployment.
Before major validation work, we typically perform a data integrity gap assessment to identify risk areas. The assessment covers: audit trail coverage (are all GxP-relevant fields captured? are deletes logged?), segregation of duties (can any single user create and approve a record?), electronic signature meaning (does every e-signature carry an explicit meaning and identity?), data lifecycle (is data creation, modification, review, approval, and archival controlled?), and interface data integrity (can data be changed in transit between systems?). The output is a gap report with risk-rated findings and a remediation plan. This assessment is particularly valuable for organizations running classic TrackWise that are preparing for either a TrackWise Digital migration or an FDA PAI (pre-approval inspection).
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Ready to Validate Your Quality Platform?

Book a validation workshop to assess your TrackWise configuration, scope your validation package, and plan a GAMP 5-aligned validation program. From first deployment to ongoing periodic review, we help life sciences companies pass inspection with confidence.

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