EU GMP Annex 11 requires computerized systems to be periodically evaluated to confirm that they remain valid and GMP-compliant. The evaluation includes, where appropriate, the current range of functionality, deviation records, incidents, problems, upgrade history, performance, reliability, security and validation status. Frequency and depth are risk-based. Part 11 has no equivalent explicit requirement, though a validated system needs lifecycle control in the US as well.
Why it matters for labeling
Tools used to compare or approve labels change over time: new software releases, new users, new file types and new configurations. A periodic review looks at what changed, what went wrong, and whether the validation still covers how the system is actually used. It is among the first things an EU inspector asks to see for a computerized system, and it is often missing for labeling tools. See also supplier qualification.
Common mistakes
- No review schedule at all
- Reviews that tick boxes without reading the incident and deviation records
- Ignoring software upgrades since the last review
- A scope that leaves out integrations with other systems
- No documented conclusion or sign-off