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.
- 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.
Blank template
System / record ID: ____________________
Prepared by / date: ____________________
Required review / approval under local procedure: ____________________
Relevant regulations and guidance
These sources apply within their stated scope. The suggested worksheet fields, test designs and fictional decisions are practitioner recommendations, unless a source requirement is expressly identified. Completing a template does not establish compliance.
Regulatory guidance / GMP guideline · United States · February 2026
Scope: Medical-device manufacturers assuring software used in production or their quality management system.
Relevance: For medical-device production or QMS software, supports selecting assurance activities from intended use, risk and available evidence. It is nonbinding guidance and does not determine other sectors’ obligations.
Status: Final / published · Checked 2026-09-21
Publication identity, scope and status checked against the linked official source. This is not an independent audit of every retained guide statement.
Read source details and applicability →Regulatory guidance / GMP guideline · European Union · January 2011 revision
Scope: Computerised systems supporting activities in the applicable EU pharmaceutical GMP context.
Relevance: For computerised systems used in EU GMP activities, informs lifecycle, supplier and record controls. Confirm applicability to the actual activity; the example does not establish it.
Status: Final / published · Checked 2026-09-21
The Commission index confirms the January 2011 operative revision. The linked PDF could not be retrieved in this check; retained detailed section mappings need review against an authorized copy.
Read source details and applicability →Regulation · United States · Current eCFR text
Scope: Electronic records and signatures within FDA Part 11 scope, tied to the underlying required records.
Relevance: Assess applicability to electronic records required by FDA predicate rules and electronic signatures used in their place. The presence of an electronic record alone is not an applicability conclusion.
Status: Final / published · Checked 2026-09-21
Publication identity, scope and status checked against the linked official source. This is not an independent audit of every retained guide statement.
Read source details and applicability →