CSV & Computer Software Assurance
Computerized system validation has been the dominant framework for GxP software compliance since the 1990s. FDA's 2022 Computer Software Assurance (CSA) draft guidance marks a genuine shift, from documentation-heavy compliance to risk-based critical thinking. Understanding both frameworks, and how they relate, is essential for anyone building or maintaining GxP systems.
Articles in this pillar
GxP Computerized Systems: LIMS, CDS, ELN, MES, CTMS, and More, A Complete Map
Every major computerized system used in pharmaceutical manufacturing and clinical operations, what each one does, the GxP data it generates, and the validation requirements that come with it.
21 CFR Part 11 and EU Annex 11: Electronic Records and Signatures Explained
A practical breakdown of 21 CFR Part 11 and EU Annex 11, what they require, how they differ, open vs closed systems, electronic signatures, and what actually gets cited in inspections.
Change Control for Validated Systems: What Triggers Revalidation and How to Manage It
A practical guide to managing changes in a validated environment, impact assessment, revalidation scope determination, documentation requirements, and the difference between changes that need full revalidation vs. those that need a brief confirmation test.
CSV Risk Assessment: How to Scope and Execute a Risk-Based Validation
A working guide to validation risk assessment, FMEA, risk ranking matrices, criticality determination, GAMP 5 software categorization, and how to use risk to set your testing scope without over-validating or under-validating.
GAMP 5 Second Edition: The Framework for Risk-Based Computer System Validation
How GAMP 5 (2022) works in practice, software categories, the V-model, risk-based validation, and what the second edition changed. For practitioners who need to understand the standard, not just cite it.
Operating Validated GxP Computerized Systems: What Happens After Go-Live
The practical operational controls required to maintain a computerized system in a validated state, handover, support services, incident management, change management, periodic review, backup and recovery, security, and archiving. Based on ISPE GAMP operational guidance.
21 CFR Part 11 and EU Annex 11: A Practical Assessment Guide
How to assess a GxP computerized system against 21 CFR Part 11 and EU Annex 11 requirements. What each requirement means in practice, common gaps, and a structured approach to Part 11 compliance assessment.
The GxP Validation Deliverable Set: What Each Document Is Actually For
A practitioner's guide to the full set of computer system validation documents, URS, FRS, IQ/OQ/PQ protocols, RTM, validation plan and report, and what each one is actually trying to accomplish.
Validating Cloud and SaaS Systems in GxP: The Shared Responsibility Model
How to approach validation for cloud-hosted and SaaS GxP systems, what IaaS, PaaS, and SaaS mean for validation scope, the shared responsibility model, and what your quality agreement must cover.
FDA Computer Software Assurance: What Changed and What Didn't
FDA's final CSA guidance (February 2026), what it actually requires, how it changes testing scope, scripted vs exploratory testing, using supplier evidence, and what the finalization means for inspection expectations.
CSV/CSA Self-Audit: Evaluating Your Computer System Validation Program
A detailed self-audit checklist for computer system validation programs, system inventory, validation documentation, testing evidence, change control, supplier management, and periodic review. Aligned with GAMP 5 Second Edition and FDA CSA final guidance.
Retroactive Validation and Legacy Systems: What to Do When GxP Systems Were Never Properly Validated
A practical guide to handling systems that have been in GxP use without proper validation, how to assess the risk, conduct a retrospective validation, manage the regulatory disclosure, and determine when a system needs replacement rather than remediation.