CSV for GxP
Regulatory Foundations for CSV : GAMP5 , 21 CFR Part 11 , EU Annex 11 , ALCOA+
Computerized System Validation sits at the intersection of regulation and good practice. These frameworks define how validation safeguards data integrity, security, and patient safety while enabling modern digital operations.
GAMP5 (ISPE)
GAMP5 is the industry standard for risk-based CSV . It guides teams to validate based on intended use, system impact, and the criticality of functions. The 2022 2nd Edition reinforces approaches for cloud services, agile delivery, and data integrity controls.
The GAMP5 V-model clarifies how requirements and testing align across the system lifecycle. See the validation lifecycle for a step-by-step view.
21 CFR Part 11
FDA 21 CFR Part 11 governs electronic records and electronic signatures in the United States. It requires controlled access, audit trails, and secure data retention to ensure records are trustworthy and reliable.
CSV activities demonstrate that systems enforce Part 11 controls and that evidence is retained for inspection.
EU GMP Annex 11
Annex 11 sets expectations for computerized systems in EU GMP environments, covering validation, risk management, security, supplier assessment, and data integrity. It complements Part 11 but emphasizes maintaining a validated state over time.
Annex 11 also calls for periodic review and change control, which align to key validation documentation.
ALCOA+
ALCOA+ defines data integrity expectations: Attributable, Legible, Contemporaneous, Original, Accurate, plus Complete, Consistent, Enduring, and Available. Regulators use these criteria to assess whether data is reliable and traceable.
CSV evidence must show that systems capture, protect, and retain data according to ALCOA+ principles. You can reference these terms in the glossary.
Translate regulations into execution
We map these requirements into practical validation plans, ensuring audits and inspections focus on evidence that matters. Our CSV services align with GAMP5 and the regulatory controls that shape your compliance obligations.