Ask four questions
- What moved?
- What transformed?
- What could be lost or changed?
- How will you verify completeness and accuracy?
Follow the migration
Source → Transformation → Target → Reconciliation → Exception handling
Define the source scope, mappings, transformation rules and acceptance criteria. Reconcile records, relationships and critical fields. Investigate exceptions and retain the results before accepting the migrated use.
Worked exampleFictional example. Source and target contain the same number of CAPA records, but attachments link to the wrong parents. Matching counts are useful; they do not establish relationship accuracy.
Include audit history, signatures, metadata and retrieval where they are part of the required record. Keep a controlled recovery or rollback route until acceptance.
Detailed practice, examples and references
Migration plan
Define migration scope, source and target data, authoritative inventory, mapping and transformation rules, permitted cleansing, migration tools, environments, roles, reconciliation, exception handling, historical records, audit trail, electronic signatures, attachments, record relationships, retention, access, verification, rollback or recovery, and the migration summary approval.
Verification strategy
Record counts are one control, not a complete conclusion. Combine control totals, field-level reconciliation, transformation checks, exception review, risk-based record sampling, 100-percent verification of critical relationships or signatures where justified, and end-user retrieval under representative roles. Predefine acceptable differences and how every exception will be dispositioned.
Completed fictional eQMS migration
Ten years of corrective and preventive action (CAPA) records move from a legacy eQMS. The source inventory contains records, attachments, approval history, electronic signatures, audit history, and linked change-control records. Initial counts match. Relationship testing finds that attachments for records with duplicate legacy filenames link to the wrong parent. Signed PDF copies also omit signature meaning even though signer and time are present.
The key strategy is corrected to use immutable record and attachment identifiers. The export is revised to preserve signer name, date and time, meaning, and record revision. The team repeats full relationship reconciliation for the affected population, retrieves representative open and closed records, verifies role access and retention, and documents unresolved source-data limitations before approving migration and legacy retirement.
Migration summary
State the approved population, tools and versions, executions, totals, sampling basis, exceptions, deviations, resolved and retained limitations, retrieval results, security and access confirmation, source freeze, cutover, rollback decision, and authorization to use or retire the source.
Regulatory and procedural context
Primary sources. 21 CFR Part 11 ↗ addresses accurate and complete copies, protection, ready retrieval, audit trails, and signature-record linking for records in scope. EU GMP Annex 11 ↗ is relevant to lifecycle data integrity and migration for applicable GMP systems.
Company procedure. The organization’s approved validation, change-control, supplier-management, information-security, data-integrity, records-retention, and Quality approval procedures determine the required records, roles, and approval route.
CSVtoCSA practitioner interpretation. Migration evidence should demonstrate preserved record meaning and use, not only technical movement or matching totals. This is a recommended validation approach, not a statement that every listed activity is a direct regulatory requirement.
Practitioner guidance by Sandip Thorat · Simplified 17 September 2026. Apply the requirements and approved procedures relevant to your system. Report a correction.
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