The rules that govern computerized systems in life sciences — in plain language.
Every validation decision Valitech makes traces back to a small set of regulations and standards. This page explains what they are and how they fit together, so you can see the framework your systems are actually being held to. It is a reference, not a sales pitch.
FDA 21 CFR Part 11
The U.S. FDA rule governing electronic records and electronic signatures. Where a regulated company creates, modifies, stores, or retrieves GxP records electronically, Part 11 sets the expectations: validated systems, secure and traceable audit trails, unique user access, and electronic signatures that are reliably linked to their signer. It is the reason audit trails, access control, and system validation are non-negotiable rather than optional.
EU GMP Annex 11
The European counterpart to Part 11. Annex 11 is the EU GMP guidance on computerised systems, and it covers much of the same ground — risk management, validation, data integrity, audit trails, and supplier oversight — from the European regulators' perspective. Any manufacturer exporting into the EU is measured against it, which makes it directly relevant to Indian and Asian pharma serving European markets. Part 11 and Annex 11 overlap heavily; a system built to satisfy both is stronger than one built for either alone.
GAMP 5 (2nd Edition)
Not a regulation but the industry framework most inspectors expect you to follow. GAMP 5 — A Risk-Based Approach to Compliant GxP Computerized Systems, updated to its 2nd edition by ISPE in 2022 — sets out the risk-based, V-Model methodology behind validation: categorize systems by risk, scale the effort to that risk, and trace every requirement through to the test that proves it. Valitech's validation deliverables follow GAMP 5.
Computer Software Assurance (CSA)
The direction the field is moving. In September 2025 the FDA finalized its Computer Software Assurance (CSA) guidance, which formalizes a risk-based, least-burdensome approach to assuring software used in production and quality systems — focusing testing effort on the functions that matter most to product quality and patient safety, and making better use of vendor evidence for lower-risk functions. CSA is the evolution of traditional CSV, and it is closely aligned with the risk-based thinking in GAMP 5.
This matters because much of the industry still validates every system with the same heavy documentation regardless of risk. A validation partner working to CSA principles concentrates rigour where the risk is, rather than spreading it thin — which is exactly the risk-based approach Valitech already applies.
ALCOA+ data integrity
The principles regulators use to judge whether your data can be trusted. Records should be Attributable, Legible, Contemporaneous, Original, and Accurate — the original ALCOA — plus Complete, Consistent, Enduring, and Available. Most modern data-integrity findings, and much of what Part 11 and Annex 11 are designed to protect, come back to these nine words. Validation is, in the end, how you demonstrate ALCOA+ for the systems that hold your data.
How it fits together
Part 11 and Annex 11 are the rules. GAMP 5 is the method for meeting them. CSA is the risk-based refinement of that method. ALCOA+ is the outcome they all protect — trustworthy data. Valitech works across all four so your systems satisfy the regulation, the inspector, and the data.
See how we apply this in Computerized System Validation, or talk to us about your systems.