CSV for GxP
What is CSV and Why It Matters in GxP
Computerized System Validation ( CSV ) is the structured proof that a system consistently performs its intended use. In regulated environments, validation is what ties technology decisions to patient safety, product quality, and operational compliance.
Why CSV is essential in GxP
GxP industries rely on computerized systems to control manufacturing, distribution, clinical trials, and pharmacovigilance. CSV proves those systems are fit for use, with traceable requirements, tested controls, and documented evidence aligned to GAMP5 , 21 CFR Part 11 , and EU Annex 11 expectations.
It also protects data integrity (ALCOA+) by ensuring audit trails, access controls, and change control processes are tested and maintained over the system lifecycle.
What happens without validation
- Incomplete audit trails or missing evidence for critical activities.
- Inconsistent release decisions that put product quality at risk.
- Data integrity gaps that can trigger regulatory findings.
- Delayed launches when validation is retrofitted under time pressure.
Where CSV applies in GxP
CSV applies to systems that can impact product quality or patient safety, including manufacturing execution, laboratory systems, distribution platforms, and safety reporting tools. Each GxP domain has different risks, so the validation strategy should reflect the domain’s critical functions.
Explore GxP application areas →How we help
Our teams translate regulatory expectations into practical validation roadmaps, ensuring your CSV approach is right-sized and audit-ready. We align documentation, testing, and change control to keep systems in a validated state.
See CSV services →Ready to align your CSV roadmap?
Start with a clear assessment of your current validation posture, then map the lifecycle activities needed to support inspection-ready evidence.