Checklist: Computerized-System Elements of Equipment Periodic Review (Annex 11)

This is a ready-to-use checklist for the computerized-system side of an equipment periodic review. It is scoped to GMP equipment that carries embedded or closely coupled software, a chromatography data system riding on an HPLC, a PLC or HMI controlling a process skid, an autoclave with a recipe-management controller, a balance whose firmware calculates and stores results, rather than to a standalone enterprise system. Run it alongside, or folded into, the equipment periodic review, mark each item Pass, Fail, or N/A with evidence, and route every Fail to CAPA. A filled specimen follows. This content is general educational reference, not legal or regulatory advice.

This checklist backs up the “computerized-system elements” line item in the Report: Equipment Periodic Review; it gives that line item named evidence instead of a single asserted cell. For a standalone GxP computerized system that is not embedded in a piece of equipment (an MES, a LIMS, a document management system), use the SOP: Periodic Review of GxP Computerized Systems and its paired evidence worksheet and report instead. For a full automation system (PLC, SCADA, DCS) reviewed as its own validated system rather than as part of one equipment asset’s review, see the Checklist: Automation System Periodic Review.

Field	Entry
Equipment ID and description	`<<FILL>>`
Embedded/coupled system name and version	`<<FILL: e.g. CDS version, controller firmware version>>`
Review period	`<<FILL>>` to `<<FILL>>`
Reviewed alongside equipment periodic review #	`<<FILL: report number>>`
Combined or separate track (see section 0)	`<<FILL>>`
Reviewer	`<<FILL: name, function>>`
Validated baseline reference	`<<FILL>>`

Section 0: Combine or separate

#	Item	Pass / Fail / N/A	Evidence
0.1	A decision is on record for whether this system’s computerized elements are folded into the single equipment periodic review or run as a distinct, explicitly evidenced track
0.2	If run separately, the equipment periodic review report references this checklist’s conclusion and date, and the two conclusions agree
0.3	The basis for the decision (narrow, unchanging GxP function administered by the equipment owner, versus broadly integrated software administered on an IT cadence) is stated, not assumed

Section 1: Audit trail review status

#	Item	Pass / Fail / N/A	Evidence
1.1	The audit trail was enabled and complete for the whole review period, with no unexplained gaps
1.2	Audit trail reviews were performed at the frequency the governing procedure requires, for every interval in the period, not sampled after the fact
1.3	Critical entries (result changes, re-integrations, deletions, aborted or renamed runs, clock changes, privilege changes) were examined, not only counted
1.4	Exceptions found during review were recorded, routed, and closed, with no affected data used before resolution

Section 2: User access and privilege review

#	Item	Pass / Fail / N/A	Evidence
2.1	The active account list was reconciled against current, authorized personnel for the period
2.2	Leavers were removed within the expected timeframe; none held active access past their departure date
2.3	Privileged (administrator/configuration) accounts are named to specific individuals, justified, and limited to those who need them
2.4	Segregation between who operates, who configures, and who administers the system still holds; no single account spans all three without a documented reason
2.5	Shared or generic logins, if any exist, are documented as an exception with compensating controls, not treated as routine

Section 3: Backup and restore verification

#	Item	Pass / Fail / N/A	Evidence
3.1	Backups completed on schedule for the whole period, with any failures re-run and closed
3.2	A restore was actually tested during the period, not only assumed from a green backup completion log
3.3	The restore test verified data integrity (record counts, sample checks) against the source, not just that a file was produced

Section 4: Patch and version control against the validated baseline

#	Item	Pass / Fail / N/A	Evidence
4.1	The live software/firmware version matches the approved validated baseline, or every departure is traceable to an assessed change record
4.2	Every patch applied in the period carries a risk assessment, performed before or promptly after application
4.3	Where a patch changed a GxP-relevant function, regression testing scaled to the risk was performed and is on file
4.4	The validated baseline record itself is current and matches what periodic review compared against

Section 5: Security configuration

#	Item	Pass / Fail / N/A	Evidence
5.1	Configuration-level security settings (network exposure, unused ports or services, default credentials) have not drifted from what was validated or last assessed
5.2	Physical access to the control cabinet, panel, or embedded computer is restricted and consistent with the access review in section 2
5.3	Any known vulnerability or security event affecting the system in the period was assessed for GxP impact

Section 6: Outcome

Field	Entry
Overall verdict	`<<FILL: satisfactory / satisfactory with actions / non-conformance, escalate>>`
Actions raised	`<<FILL: CAPA / change references>>`
Fed back to the equipment periodic review report as	`<<FILL: reference, e.g. section 8 line item>>`
Next review due	`<<FILL: date, aligned to the equipment or system review cycle>>`

Role	Name	Signature	Date
Reviewer	`<<FILL>>`
System/equipment owner	`<<FILL>>`
QA approval	`<<FILL>>`

References

EU GMP Annex 11 (Computerised Systems), the periodic evaluation clause, which contemplates evaluation of current functionality, deviation and incident records, upgrade history, performance, reliability, and security. EU GMP Annex 15 (Qualification and Validation, 2015 revision). 21 CFR Part 11 (electronic records and electronic signatures); 21 CFR 211.68 (automatic, mechanical, and electronic equipment). ISPE GAMP 5, Second Edition (2022), A Risk-Based Approach to Compliant GxP Computerized Systems.

Confirm the current version and clause numbers of each reference before issue.

Filled specimen

The following shows the checklist completed for a chromatography data system serving a single HPLC used in release testing, reviewed alongside the instrument’s equipment periodic review. Numbers and IDs are illustrative.

Header: HPLC-11 with CDS version 4.2.1. Review period 01 June 2025 to 31 May 2026. Reviewed alongside equipment periodic review PR-2026-014. Combined track: this checklist is run as a distinct, explicitly evidenced track because the CDS serves three other instruments in the lab beyond HPLC-11 and is administered by the IT/informatics team, not by the instrument’s own maintenance group.

#	Item	Result	Evidence
1.2	Audit trail reviews at required frequency	Pass	52 weekly reviews on file, no gaps
1.3	Critical entries examined	Pass	14 re-integrations reviewed, all with recorded scientific justification
2.2	Leavers removed on time	Fail	One analyst account remained active 11 days after departure; access removed same day as found, CAPA-2026-077 raised
3.2	Restore actually tested	Pass	Restore test RST-2026-009, 18 records sample-verified against source
4.1	Live version matches baseline	Pass	Version 4.2.1 confirmed against CFG-CDS-011 rev 2
4.2	Patches risk-assessed	Pass	3 patches in period, all with impact assessments on file
5.1	Security configuration unchanged	Pass	Configuration scan against baseline, no unassessed drift

Verdict: Satisfactory with actions. The leaver access gap (section 2.2) is the only Fail; it is a one-time lapse in the leaver notification handoff, not a pattern, and was corrected the day it was found during the review rather than left open until the report was issued. Fed back to equipment periodic review PR-2026-014, section 8, as “computerized-system elements: satisfactory with actions, see checklist CSC-2026-031.” Next review due 31 May 2027, aligned to the instrument’s own 12-month cycle.

This specimen shows the two things this checklist exists to force: a named piece of evidence behind every line rather than a single asserted “satisfactory” cell, and an explicit statement of why the computerized-system elements were tracked separately from the equipment review for this particular instrument rather than folded in.

Common inspection findings this checklist prevents

An equipment periodic review that states “computerized-system elements: satisfactory” with no audit trail, access, backup, version, or security evidence behind it.
A leaver’s account still active on a GMP data system, missed because access review was assumed to be someone else’s responsibility.
Backups reported as running with no restore ever actually tested.
A live software or firmware version that has quietly diverged from the validated baseline with no change record explaining why.
A broadly integrated system (serving multiple instruments) reviewed only as a line item inside one instrument’s equipment report, with no coordination against the other instruments it also serves.

How to adapt this checklist

Use this checklist for equipment-embedded or closely coupled software; route a standalone enterprise system to the general computerized-system periodic review SOP instead, and a full automation system reviewed as its own validated asset to the automation periodic review checklist.
Set the combine-or-separate decision in section 0 for each system once, in policy, rather than re-deciding it ad hoc at every review.
Point sections 1 through 5 at your real audit trail review, access management, backup, change control, and security procedures so the evidence column names an actual system of record.
Feed the outcome directly into the equipment periodic review report’s computerized-system line item, by reference, rather than re-typing a summary that loses the evidence trail.
Confirm every regulation in the References section against the current published version before issue.

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