Version 2.0 · Updated 2026-09-21 · Retirement
Preserve required records and meaning, confirm retrieval, remove access and interfaces, terminate supplier services, and approve retirement.
Adapt this template to your intended use, applicable requirements, and approved procedures.
When to use it
Before retiring, replacing, archiving, or terminating a regulated computerized system or service.
- Dependent-system and record inventory
- Retention and retrieval obligations
- Approved archive/migration, cutover and supplier exit plan
Field instructions
- Scope and reason for retirement: Identify the system/service or process, version and accountable roles. Specify the scope and supporting record rather than relying on a product name alone.
- Replacement system: Identify the system/service or process, version and accountable roles. Specify the scope and supporting record rather than relying on a product name alone.
- Record inventory and retention: Identify the applicable retention basis, accountable record owner and retrieval method. Confirm obligations and test retrieval before deletion or ending supplier access.
- Archive or migration method: Identify the applicable retention basis, accountable record owner and retrieval method. Confirm obligations and test retrieval before deletion or ending supplier access.
- Metadata and audit trail: Identify the required record context, history, identity and relationships. Explain how integrity, attribution and retrieval will be preserved and checked.
- Electronic signatures and relationships: Identify the required record context, history, identity and relationships. Explain how integrity, attribution and retrieval will be preserved and checked.
- Access and retrieval testing: Identify the account or role, permitted actions and business justification. Check authorization, inappropriate combinations, inactive accounts and evidence of removal or correction.
- Interfaces and dependent systems: Identify the system/service or process, version and accountable roles. Specify the scope and supporting record rather than relying on a product name alone.
- User and privileged access removal: Identify the account or role, permitted actions and business justification. Check authorization, inappropriate combinations, inactive accounts and evidence of removal or correction.
- Supplier termination and deletion: Identify the applicable retention basis, accountable record owner and retrieval method. Confirm obligations and test retrieval before deletion or ending supplier access.
- Deviations and limitations: State what is outside the assessed use or evidence. Explain the consequence and any restriction; do not treat missing information as a pass.
- Final summary 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 →