This is a ready-to-use log for tracking changes to an AI capability used in regulatory and CMC content production: a vendor’s base-model update, a change to the drafting prompt or retrieval configuration, or a new source added to the model’s grounding. Each of these is a change you may not have initiated, and each requires a defined re-verification before continued reliance. Replace every <<FILL: ...>> placeholder, keep one row per change event, and maintain the log under document control. A field-definition table, the blank log, and a filled specimen follow. Verify each cited regulation against the current source.
Field definitions
| Field | Definition |
|---|---|
| Change ID | Unique identifier for this change event |
| Date detected / announced | When the change was noticed or the vendor announced it |
| Change type | Vendor base-model update / Prompt or retrieval-config change / New source data added / Guardrail change |
| System / capability affected | The named AI capability and version prior to the change |
| Detected by | How the change was found: vendor notice, output-quality drift noticed by a reviewer, scheduled check |
| Re-verification performed | The known-content check or representative re-test run against the changed capability |
| Re-verification outcome | Pass / Fail / Pass with new limitations |
| Reliance decision | Continue reliance / Hold reliance pending fix / Reliance resumed with added controls |
| Reviewed by | Named reviewer and date |
Log
| Change ID | Date detected | Change type | System / capability | Detected by | Re-verification performed | Outcome | Reliance decision | Reviewed by |
|---|---|---|---|---|---|---|---|---|
<<FILL>> | <<FILL>> | <<FILL>> | <<FILL>> | <<FILL>> | <<FILL>> | <<FILL>> | <<FILL>> | <<FILL>> |
<<FILL>> | <<FILL>> | <<FILL>> | <<FILL>> | <<FILL>> | <<FILL>> | <<FILL>> | <<FILL>> | <<FILL>> |
Instructions
- Open a new row the same day a vendor model change is announced or detected, treating it as an uninitiated change per the governing SOP, before any further reliance on the capability for filed content.
- Run the re-verification against a known set of representative content (the same source documents used to validate the original configuration) and record the actual outcome, not just “checked.”
- If the outcome shows degraded quality or a new failure pattern, hold reliance, document the added controls or the fix required, and do not resume until re-verification passes.
- Retain this log as a GxP record supporting the validated state of the AI capability; reference it from the periodic review of the AI-assisted process.
- A “Pass with new limitations” outcome must state the limitation explicitly (for example, a category of claim the model now handles less reliably) so reviewers can watch for it going forward.
Acceptance criteria
- Every known vendor model change, prompt change, retrieval-source addition, or guardrail change affecting the capability has a row, including changes detected by output drift rather than a vendor announcement.
- No change proceeds to continued reliance without a recorded re-verification outcome.
- A failed or limited outcome blocks reliance until resolved, with the resolution recorded in a follow-up row or cross-reference.
- The log is reviewed at the periodic review of the AI-assisted regulatory content process.
Filled specimen
| Change ID | Date detected | Change type | System / capability | Detected by | Re-verification performed | Outcome | Reliance decision | Reviewed by |
|---|---|---|---|---|---|---|---|---|
| AIC-2026-011 | 03-Mar-2026 | Vendor base-model update | Regulatory drafting assistant v4.2 to v4.3 | Vendor release notice | Re-ran 12 representative study-report summarization tasks from the original validation set, compared output to prior baseline | Pass, no material difference in accuracy or citation behavior | Continue reliance | J. Alvarez, 05-Mar-2026 |
| AIC-2026-014 | 22-Jul-2026 | Prompt change | Regulatory drafting assistant v4.3 | Planned change by Data Science to improve section-heading formatting | Re-ran the same 12-task set | Pass with new limitation: model now occasionally omits the source citation on formatting-only edits; reviewers alerted to check citation presence specifically after a formatting pass | Reliance resumed with added reviewer check | J. Alvarez, 24-Jul-2026 |
The second row shows why “Pass with new limitations” exists as its own outcome: the change did not fail outright, but it introduced a specific new failure mode that reviewers needed to know to watch for, which a simple pass/fail field would have hidden.
Common inspection findings this log prevents
- A vendor model update taking effect with no record that anyone noticed, checked, or approved continued reliance.
- Re-verification claimed in an SOP’s general language but no actual per-event record showing it happened.
- A degraded output pattern discovered by a reviewer informally, with no record of the change that caused it or the decision to continue relying on the capability anyway.
- No mechanism connecting this log to the periodic review of the AI-assisted process, so a pattern of frequent, poorly-managed vendor changes goes unnoticed.
References
Section 6 (change control) of the governing SOP for AI-assisted regulatory and CMC content. ICH Q9(R1), Quality Risk Management. Software supplier assessment record for the AI vendor, per software supplier assessment.
Confirm the current version of any cited procedure before issue.