Completed teaching records · Editorial update 21 September 2026 · Synthetic results; no real approval is represented.
Situation — fictional capstone
PRA-01 is a fictional protocol-review assistant at a medical-device manufacturer. All records, identifiers, versions, results and decisions below are synthetic teaching examples. They are connected to Chapters 4, 11 and 15; they are not evidence that a commercial product or real workflow is validated.
The proposal is to use AI findings to reduce the extent of independent review of production-equipment validation protocols. The evidence below does not support that expanded production reliance. The example shows how a validation summary should retain unfavorable evidence and state the permitted boundary.
Intended use — IU-01
System description — SYS-01
The evaluated configuration is fictional application PRA-01 v0.8, hosted generative model M-2026-09-eval, prompt P-03, parser PAR-02 and retrieval configuration RET-04. These identifiers describe a fixed teaching configuration, not real supplier version guarantees.
GxP assessment — GXP-01
The assumed manufacturer is subject to applicable US device quality-system requirements. The assistant influences a regulated validation activity even when called advisory. Include omission risk, source support, record handling and the final reviewer workflow in the local assessment. Confirm actual QMSR, incorporated standard and record/signature applicability with the responsible Quality and Regulatory Affairs roles; this example does not establish the same scope in every country or for every use.
The assistant is production/QMS support software in this fictional use, not a medical-device function. General AI frameworks inform risk management voluntarily. Device-specific AI modification guidance is not treated as permission for this internal use.
Supplier assessment — SUP-01
Testable requirements and functional risk assessment
Residual risk is not marked acceptable merely because a control is listed. R-01 through R-03 remain unresolved for expanded reliance after the observed results. Passing R-04 through R-06 checks is limited to the tested configuration and scenarios.
Test plan — TP-01
Freeze the configuration and reference rubric before execution. Qualified reviewers establish and adjudicate 40 distinct reference issues across 12 fictional documents: 10 critical and 30 major. Development cases are separate; supported formats, clean control material and known failure conditions have a documented rationale. Unsupported scans and other languages are excluded from the intended use and challenged for rejection.
Exploratory testing complements planned challenges; it does not replace the predefined acceptance basis. A finding that changes the system becomes a deviation and triggers a justified retest. Cases used to tune a fix are no longer untouched evaluation cases.
Evidence available
These are the same synthetic component results used in Chapter 11. The 40 reference issues are not 40 documents.
There are six additional false findings, so the AI reports 38 findings. Precision is 32 ÷ 38 = 84.2%; recall is 32 ÷ 40 = 80%; critical-issue recall is 8 ÷ 10 = 80%. The critical-miss criterion fails. These results describe the component under the study conditions, not the complete workflow or a population-wide rate.
Human-review evaluation — HR-01
Each of six qualified reviewers completes two assisted and two unassisted sessions. Each of the 12 documents is reviewed once per condition by different reviewers; a participant never sees the same document twice. Order and assignments are balanced. Reference results are independently adjudicated and withheld from participants until completion.
Assisted reviewers recover four of the eight AI omissions, including one critical issue. They reject four of six false findings and accept two; no additional false findings are introduced in this simplified example. The remaining critical miss and false acceptances fail the proposed reliance criteria. Shared documents and repeated observations from reviewers limit independence. This small study does not establish causal superiority or zero future risk in either condition.
Traceability — RTM-01
Deviations and unresolved conditions — DEV register
Decision reasoning
Passing permission, record-retrieval and recovery checks does not offset critical misses or ineffective review. The AI component and the complete workflow answer different evidence questions. Neither the 80% recall nor the 36 correct final assisted findings establishes fitness for reduced independent review.
Example decision record
Validation summary VSR-01.
Conclusion: Expanded production reliance is not approved. PRA-01 may remain only in the authorized restricted evaluation environment using synthetic or separately approved data. Full required review continues; approval, source editing and workflow actions remain technically disabled. This is the fictional decision, not a signed approval by an actual person.
The summary links IU-01, SYS-01, GXP-01, SUP-01, TP-01, HR-01, RTM-01 and all open deviations. Acceptance failures, coverage limits and the unresolved supplier condition are visible. The Quality and process-owner roles would decide any future release under the actual local procedures.
Ongoing controls during restricted evaluation
The weekly/monthly frequencies are fictional pilot choices, not universal regulatory requirements. A production plan must match actual risk, change rate and applicable procedures.
Evidence needed before reconsideration
Address the causes of critical misses, misleading completeness and false acceptance. Record revised requirements and configuration, qualify representative users, resolve supplier change arrangements, and run an appropriately protected new evaluation. Include challenging and ordinary cases, relevant variability, access/recovery controls and an analysis that respects document and reviewer dependencies. Do not erase the original failed results or describe retesting used for tuning as independent evidence.
The printable worked case includes these completed records. Use the linked blank worksheets to build a local record set; adapt the fields, acceptance basis and approvals to the actual procedures and requirements.
Final exercise
A sponsor asks you to remove the critical-miss results from the presentation because overall performance looks promising. What belongs in the decision package?
Worked answer: Retain the failed acceptance criteria, critical misses, unresolved supplier condition and reviewer failures. Connect each to proposed reliance, corrective actions and required new evidence. A release decision must remain assessable even when the appropriate outcome is to withhold the proposed use.
Expected records
The linked intended use, system description, assessments, requirements, risk analysis, test plan/results, reviewer evaluation, traceability, deviations and validation summary. Adapt record names and detail to the applicable procedures; these are practitioner examples, not a universal mandatory document list.