# AI GxP assessment

Version 2.0 · Updated 2026-09-21 · Assessment

Record actual use, influence and the requirements that need a local applicability decision.

Adapt this template to your intended use, applicable requirements, and approved procedures.

## When to use it

Use when you need to record actual use, influence and the requirements that need a local applicability decision.

## Information needed before starting

- Defined AI use, authority limits and assessed configuration
- Controlled sources and independent reference results relevant to this worksheet
- Applicable risk assessment, acceptance basis and responsible reviewers

## 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 |

## Related guidance

- [Read chapter 4: GxP Applicability for AI](https://csvtocsa.com/ai-assurance-academy/ai-in-csv-csa-chapter-4-gxp-applicability-and-risk-based-scoping)

- [Read chapter 20: AI Release Decision: Complete Case Study](https://csvtocsa.com/ai-assurance-academy/ai-in-csv-csa-chapter-20-end-to-end-case-study-and-inspection-readiness)

Canonical page: https://csvtocsa.com/worksheets/ai-gxp-assessment