Practitioner template
AI Use Assessment Template
Define and evaluate an AI-enabled GxP use, its decision authority, failure scenarios, human review, evidence, monitoring, and revalidation criteria.
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- Intended use and AI function
- Decision authority and prohibited uses
- Data, population, and reference dataset
- Failure scenarios and critical misses
- Human review design
- Performance measures and acceptance criteria
- Source verification and data integrity
- Access, audit trail, and supplier responsibilities
- Testing and release conditions
- Monitoring, stop, and revalidation criteria
Completed fictional example
Fictional teaching example: This is not an executed or approved validation record.
- Intended use and AI function
- Draft nonauthoritative validation-protocol review comments from permitted documents
- Decision authority and prohibited uses
- Qualified reviewer disposes findings; AI cannot approve, reject, sign, or release a document
- Data, population, and reference dataset
- Approved English-language protocol types with independently established reference findings
- Failure scenarios and critical misses
- Missed approval, false traceability gap, wrong source version, unsupported compliance claim
- Human review design
- Reviewer sees source passage, requirement, and rationale and can accept, reject, or request clarification
- Performance measures and acceptance criteria
- Critical-finding recall, false findings, citation correctness, performance by issue type, and reviewer detection
- Source verification and data integrity
- Immutable source version and page/section reference retained with the potential finding
- Access, audit trail, and supplier responsibilities
- Role-restricted use; input, version, output, disposition, and change recorded
- Testing and release conditions
- Representative challenge set and human-workflow study; scanned handwritten records excluded
- Monitoring, stop, and revalidation criteria
- Stop on critical-miss threshold, source failure, unauthorized action, or material model/prompt/parser change