# Supplier Evidence Review

Version 2.0 · Updated 2026-09-21 · Planning

Document which supplier evidence is accepted, what it supports, its limitations, and the local validation evidence still required.

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

## When to use it

When supplier documents, tests, certifications, or reports are proposed as validation support.

## Information needed before starting

- Identifiable supplier evidence and assessed version
- Local requirements and risk assessment
- Details of local configuration and operating differences

## Field instructions

- **Supplier evidence source:** Reference the exact evidence, version, date and assessed conditions. Explain the claim it supports, how it was reviewed and what remains unproven locally.
- **Version, date, and scope:** Record the exact version/release and effective date from an authoritative source, including configuration identifiers needed to reproduce the assessment.
- **GxP function or risk supported:** Identify the function or requirement and its controlled reference. Explain the regulated process or record that depends on it.
- **Review performed:** Describe the review undertaken, the claim supported and the conditions of reliance. Link the reviewed evidence and record unresolved questions.
- **Credibility and currency:** Reference the exact evidence, version, date and assessed conditions. Explain the claim it supports, how it was reviewed and what remains unproven locally.
- **Accepted use:** Describe the review undertaken, the claim supported and the conditions of reliance. Link the reviewed evidence and record unresolved questions.
- **Limitations:** State what is outside the assessed use or evidence. Explain the consequence and any restriction; do not treat missing information as a pass.
- **Local configuration or process gap:** Identify the system/service or process, version and accountable roles. Specify the scope and supporting record rather than relying on a product name alone.
- **Additional evidence required:** List the unanswered questions or missing evidence, the action owner and due date. Explain what cannot be concluded until they are resolved.
- **Reviewer conclusion and approval:** Record the supported decision, restrictions, unresolved issues and rationale. Identify the accountable reviewer/approver and dated evidence under your procedure.

Define the specific system, service, change, population, and intended use.

Complete each field from available records and accountable interviews; record unknowns rather than guessing.

Link conclusions to affected GxP functions, failure scenarios, controls, evidence, and approval.

Adapt the structure to the organization’s approved procedures and document-control process.

## Completed fictional example

Fictional teaching example; this is not an executed or approved validation record.

| Field | Completed example |
| --- | --- |
| Supplier evidence source | Fictional supplier regression summary |
| Version, date, and scope | eQMS 8.5; standard workflow engine; 2 September 2026 |
| GxP function or risk supported | Unchanged standard state-transition processing |
| Review performed | Scope, environment, acceptance criteria, failures, and defect list reviewed |
| Credibility and currency | Version specific and approved by supplier Quality |
| Accepted use | Supports unchanged engine behavior |
| Limitations | Does not cover local routing, identity mapping, open legacy records, or signed export |
| Local configuration or process gap | Site/severity rules and Quality approval path |
| Additional evidence required | Customer branch, unauthorized, state-transition, signature, and recovery tests |
| Reviewer conclusion and approval | Accept with stated limitations; Quality approval required |

## Blank template

System / record ID: ____________________

Prepared by / date: ____________________

Required review / approval under local procedure: ____________________

| Field | Your entry |
| --- | --- |
| Supplier evidence source | ____________________ |
| Version, date, and scope | ____________________ |
| GxP function or risk supported | ____________________ |
| Review performed | ____________________ |
| Credibility and currency | ____________________ |
| Accepted use | ____________________ |
| Limitations | ____________________ |
| Local configuration or process gap | ____________________ |
| Additional evidence required | ____________________ |
| Reviewer conclusion and approval | ____________________ |

## Related guidance

- [Read the related practical guide](https://csvtocsa.com/learn/guidance/existing-supplier-evidence-assessment)

Canonical page: https://csvtocsa.com/templates/supplier-evidence-review