Version 2.0 · Updated 2026-09-21 · Planning
Plan and verify migration scope, mapping, transformation, reconciliation, exceptions, records, signatures, relationships, access, and retrieval.
Adapt this template to your intended use, applicable requirements, and approved procedures.
When to use it
Before migration execution, cutover, archive, or source-system retirement.
- Record inventory, retention rules and source/target schema
- Approved mapping, cleansing and reconciliation rules
- Cutover, rollback and representative retrieval scenarios
Field instructions
- Scope and inventory: Identify the system/service or process, version and accountable roles. Specify the scope and supporting record rather than relying on a product name alone.
- Source and target: Identify authoritative sources, receiving systems and record identifiers. Describe supported formats, units, timing, transformations and error handling.
- Data mapping and transformation: Identify the approved rule and authoritative source. Include units, identifiers, rounding, missing values and exceptional paths that could change the result.
- Cleansing rules and approvals: Record the supported decision, restrictions, unresolved issues and rationale. Identify the accountable reviewer/approver and dated evidence under your procedure.
- Migration tools and environments: Identify the assessed configuration, representative data, selected activities and expected results. Include abnormal and recovery paths and explain remaining coverage gaps.
- Reconciliation and sampling: State what will be compared or monitored, against which baseline, by whom and how often. Define discrepancy thresholds and the response.
- Exceptions and deviations: Record the issue, affected functions/records, impact, containment, action owner and resolution or expiry. Link correction and retest evidence; retain unfavorable results.
- Attachments, metadata, and relationships: Identify the required record context, history, identity and relationships. Explain how integrity, attribution and retrieval will be preserved and checked.
- Audit trail and electronic signatures: Identify the required record context, history, identity and relationships. Explain how integrity, attribution and retrieval will be preserved and checked.
- Retention, access, and retrieval: Identify the account or role, permitted actions and business justification. Check authorization, inappropriate combinations, inactive accounts and evidence of removal or correction.
- Cutover, rollback, and source freeze: Identify the controlled transition or recovery plan, decision owner and evidence of restoration/retrieval. State how incomplete work is detected and reconciled.
- Migration 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 →