AI GxP assessment
Record actual use, influence and the requirements that need a local applicability decision.
Adapt this worksheet to your applicable procedures, intended use and requirements. Fictional examples are teaching material, not execution evidence.
Field instructions
- Intended use: Describe the specific task, permitted reliance and exclusions.
- Users: Identify roles, qualifications and responsibility for decisions.
- Process supported: Identify the regulated or nonregulated process and jurisdiction.
- Inputs and sources: Identify source documents, revisions and authority.
- Outputs: Describe drafts, findings, records and actions.
- Influence on work or decisions: Trace how output or omission can change work or a decision.
- Human review: Describe the full verification and independent review required.
- Failure consequences: Describe incorrect and missing outputs and possible process effects.
- Requirements requiring assessment: Identify relevant sector, record and local requirements without assuming universal applicability.
- Scope conclusion and rationale: State included functions, limits, assumptions and unresolved questions.
- Responsible roles and evidence: Record the actual local assessment and approval process; never copy fictional approval.
Completed fictional example
Fictional GXP-01 assumes a US-market medical-device manufacturer and protocol review in a production-equipment validation process.
| Field | Completed example |
|---|---|
| Intended use / users | PRA-01 candidate protocol gaps for qualified validation personnel |
| Process / inputs | Validation protocol review; draft protocol, approved requirements, validation procedure and equipment risk assessment |
| Outputs / influence | Draft findings and cited passages may prompt protocol revision; omissions may narrow a reviewer’s attention |
| Review | Source verification plus complete independent required protocol review |
| Consequences | Missed alarm test could leave inadequate coverage; false requirement could misdirect revisions |
| Applicability questions | Assess QMSR/incorporated quality-system duties, required records and whether Part 11 is in scope; consider FDA CSA recommendations for production/QMS software |
| Conclusion | Include the application and final review workflow in local GxP/software-assurance assessment; no expanded reliance on current evidence |
| Assumptions / owner | Jurisdiction and process assumed here; Quality and Regulatory Affairs confirm actual applicability |
Blank worksheet
System / record ID: ____________________
Prepared by / date: ____________________
Required review / approval under local procedure: ____________________
| Field | Your entry |
|---|---|
| Intended use | ____________________ |
| Users | ____________________ |
| Process supported | ____________________ |
| Inputs and sources | ____________________ |
| Outputs | ____________________ |
| Influence on work or decisions | ____________________ |
| Human review | ____________________ |
| Failure consequences | ____________________ |
| Requirements requiring assessment | ____________________ |
| Scope conclusion and rationale | ____________________ |
| Responsible roles and evidence | ____________________ |
Blank results or assessment rows
| Field | Completed example |
|---|---|
| ____________________ | ____________________ |
| ____________________ | ____________________ |
| ____________________ | ____________________ |