Validation—11​.10 (a)

"(a) Validation of systems to ensure accuracy, reliability, consistent intended performance, and the ability to discern invalid or altered records."

Validation is one of the requirements where enforcement discretion will be applied. In this area, that means validation of electronic record/electronic signature (ER/ES) systems will not face any new requirements due to the Part 11 record. System validation must still be performed in compliance with the predicate rule (21 CFR 820.70(i)).

This validation should follow a defined methodology. The GAMP5 guide recommends important validation principles for companies to consider using. Significant procedural activities to perform include defining requirements, documenting system design, and testing that the system performs as defined by the design - including documenting this testing or verification.