Compliance

Periodic Review (Computerized Systems)

computerised system periodic review · annex 11 periodic review

TL;DR

A scheduled GMP review of each validated computerised system to confirm it remains fit-for-purpose, compliant, and in a validated state.

Annex 11 §11 and GAMP 5 require periodic review of validated computerised systems — typically every 1–3 years based on risk — covering deviations, change history, incidents, user/access management, backup/restore, business-continuity tests, and continued conformance to the validated state.

V5 schedules system-level periodic reviews as recurring records: evidence (change-control list, incident log, access matrix) is auto-attached and the reviewer signs off with the same audit-trail rigor as any release record.

Regulatory anchors

EU GMP Annex 11 §11
GAMP 5 (2nd Ed.)

Industries that live with this

Pharmaceutical Medical Devices Blood & Tissue

How V5 handles it

21 CFR Part 11 — the operating model, not a checkbox.

Other systems bolt Part 11 on top. V5 enforces it at the database layer so application code can never rewrite history.

Document control with hard kiosk-level training enforcement.

Versioned SOPs are only useful if operators are actually trained on the current version. V5 enforces it at the kiosk.

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