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.

Author
CSVtoCSA editorial
Published
12 September 2026
Last reviewed
2026-09-12
Version
1.0
Content type
Template
Primary references
Apply the sources and approved procedures relevant to the system
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Blank template

  1. Intended use and AI function
  2. Decision authority and prohibited uses
  3. Data, population, and reference dataset
  4. Failure scenarios and critical misses
  5. Human review design
  6. Performance measures and acceptance criteria
  7. Source verification and data integrity
  8. Access, audit trail, and supplier responsibilities
  9. Testing and release conditions
  10. 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