This is the periodic review that confirms an automation system is still in its validated state and that accumulated minor changes have not eroded it. Run it at the defined interval and after any significant change. Mark each item Pass, Fail, or N/A with evidence, and route every Fail to CAPA. A filled specimen follows. This content is educational and general; adapt it to your own quality system.
Header
| Field | Entry |
|---|---|
| System name / ID | <<FILL>> |
| ISA-95 level / GMP impact | <<FILL>> |
| Review period | <<FILL>> to <<FILL>> |
| Reviewer | <<FILL>> |
| Last validation / requalification reference | <<FILL>> |
Part 1: configuration and version integrity
| # | Item | Pass / Fail / NA | Evidence |
|---|---|---|---|
| 1 | Live program / configuration version and checksum equal the approved baseline | ||
| 2 | Programming and engineering access remains restricted; no open USB or maintenance ports found | ||
| 3 | All changes in the period went through change control (no undocumented setpoint or logic changes) |
Part 2: change, deviation, and CAPA history
| # | Item | Pass / Fail / NA | Evidence |
|---|---|---|---|
| 4 | Every change record for the period is closed or on track, with requalification done where required | ||
| 5 | Deviations involving the system are closed or tracked; no trend indicating erosion of control | ||
| 6 | Open CAPAs affecting the system are on schedule |
Part 3: data integrity controls
| # | Item | Pass / Fail / NA | Evidence |
|---|---|---|---|
| 7 | Audit trail enabled for the whole period; audit-trail reviews performed at the defined frequency | ||
| 8 | Time synchronization to the defined source is active; drift within limit; sync-failure alerting works | ||
| 9 | Unique accounts only; access list reviewed and recertified; leavers removed; roles still segregate operate/configure/administer | ||
| 10 | Alarm configuration under change control; alarm priority scheme still rationalized (not a wall of “critical”) |
Part 4: resilience and interfaces
| # | Item | Pass / Fail / NA | Evidence |
|---|---|---|---|
| 11 | Backups run per schedule; a restore was tested, not just assumed | ||
| 12 | Interfaces feeding the batch record reconciled; no unexplained gaps in the period | ||
| 13 | Historian compression / deadband settings unchanged from the validated configuration |
Part 5: outcome
| Field | Entry |
|---|---|
| Overall verdict | <<FILL: remains in validated state / conditions apply / requalification needed>> |
| Actions raised | <<FILL: CAPA / change references>> |
| Next review due | <<FILL>> |
| Role | Name | Signature | Date |
|---|---|---|---|
| Reviewer | <<FILL>> | ||
| System owner | <<FILL>> | ||
| QA approval | <<FILL>> |
References
21 CFR 211.68; 21 CFR Part 11. EU GMP Annex 11 (Computerised systems), periodic evaluation. EU GMP Annex 15. ISPE GAMP 5 (Second Edition, 2022).
Filled specimen
| # | Item | Result | Evidence |
|---|---|---|---|
| 1 | Live version equals baseline | Pass | Checksum 0x4F2A matches baseline record BL-SCADA-03 |
| 3 | All changes went through change control | Fail | Setpoint on TIC-118 found changed with no change record; CAPA-2026-041 raised |
| 7 | Audit-trail reviews performed | Pass | 26 weekly reviews on file for the period |
| 11 | Restore tested | Pass | DR restore test DR-2026-02 passed 14 May 2026 |
The Fail on item 3 is the value of the review: an undocumented setpoint change is exactly the slow erosion of the validated state that a periodic review is designed to catch before an inspector does.
Common inspection findings this checklist prevents
- The live program has drifted from the approved baseline and nobody noticed.
- “Temporary” setpoint or logic changes made during callouts never entered change control.
- Audit-trail review is required by procedure but no evidence it happened.
- Access lists still contain leavers, or shared logins reappeared.
- Backups run but a restore was never actually tested.
How to adapt this checklist
- Set your review interval from the system’s GMP impact.
- Add system-specific items (specific interfaces, specific alarm groups, specific historian tags).
- Point item 7 to your audit-trail review SOP and item 11 to your backup/restore procedure.
- Define what verdict triggers requalification versus a conditional pass.
- File the completed checklist with the system’s validation lifecycle records.