# 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 |
| --- | --- |
| ____________________ | ____________________ |
| ____________________ | ____________________ |
| ____________________ | ____________________ |