Data Migration Validation for Regulated Systems
CSV data migration is the controlled process of moving regulated records between systems and proving, with evidence, that the records keep their value, meaning, and traceability.
As your number one validation lifecycle management platform, in this guide we give you a simple path you can follow on real projects, along with acceptance criteria and an audit-ready package you can hand to inspectors. It aligns with Annex 11, Part 11, MHRA, and PIC/S expectations, and it uses plain language so your team can act on it today!
How Do You Validate a Data Migration Under GMP?
- Define scope, critical data, and risk.
- Write source→target mappings with transforms, defaults, and time zone rules.
- Trial-load to a representative environment and fix data quality issues.
- Verify mapping, integrity, and metadata, then run a data reconciliation report.
- Perform ETL validation, sampling, and 100% checks where needed.
- Handle exceptions, re-migrate as required, and document deviations and change control.
- Issue a final report that shows record meaning preserved, including audit trail and archive decisions.
See Annex 11 §4.8 and Part 11 for the regulatory backbone.
Why GXP Data Migration Validation Matters?
A migration can break trust if values shift, links break, or metadata gets lost. The baseline is clear. Annex 11 §4.8 states that validation should include checks that data are not altered in “value and/or meaning” during the migration. Use this language once verbatim, then prove it in practice with mapping, integrity, and reconciliation evidence.
Part 11 sets the expectation that electronic records and signatures must remain trustworthy, reliable, and generally equivalent to paper. That includes how they are created, maintained, archived, and retrieved after a migration.
MHRA and PIC/S reinforce lifecycle control and long-term accessibility. Your package should show that migrated or archived data stay complete, consistent, and available for inspection.
Note: Annex 11 Revision 1 has been in force since June 30, 2011. The EU opened a draft consultation to revise Chapter 4 and Annex 11 on July 7, 2025. Plan to track final changes when they are issued.
Define Scope and Data Classes
Start by deciding what will move, what will be archived, and what will be retired. Describe systems, versions, and data entities in clear terms.
Critical vs non-critical data elements
Identify master data, transactional records, electronic signatures, version history, audit trails, and attachments. Mark fields that affect product quality, patient safety, compliance, and traceability as critical. Target 100% checks for critical identity and linkage fields. Use risk-based sampling for the rest.
Migration types
Plan for one-time full loads, phased or delta loads, or hybrid approaches. Common patterns include on-prem to SaaS moves and legacy data archiving where read-only access may be the best option.
Tip: Decide early how you will provide inspectors access to legacy records and audit trails if you choose to archive instead of migrate. MHRA and PIC/S care about long-term accessibility.
Plan the Migration (CSV Deliverables)
Begin with a user requirements specification that adds migration needs to your system URS. Add a risk assessment that focuses on data integrity hazards like truncation, rounding, time zone shifts, code set mismatches, orphaned links, missing attachments, and lost signature context.
Produce a migration strategy with a full mapping spec: source→target fields, transforms, code and unit mappings, default values, null handling, and time zone rules. Include sampling plans, acceptance criteria, reconciliation rules, and a rollback plan.
If a vendor or integrator performs the ETL, define roles, deliverables, and evidence clearly. Annex 11 expects meaningful supplier oversight across the lifecycle.
Build Evidence That Record Meaning Preserved
Your proof lives in three areas: mapping verification, referential integrity, and metadata or audit trails.
Mapping Verification
Check field-by-field transfers with examples, including vocabulary mapping, unit conversions, and date/time normalization. Show how free text, numeric precision, and controlled terms are handled. Defect patterns like trailing spaces, UTF-8 issues, and overlength values should be part of your test set.
Referential Integrity and Traceability
Prove that links remain intact across objects. In quality systems, that might be test→deviation→CAPA→change→approval. In R&D, sample→test result→report→sign-off. If any object can exist without its parent, explain the rule and show how orphans are found and resolved.
Metadata and Audit Trails
Decide whether to migrate audit trails or to keep them in a validated, read-only legacy system. Either way, you must be able to access, read, and reconcile events for inspection. Document user access controls and retrieval instructions in the final package. MHRA and PIC/S expect risk-based decisions that still protect integrity and accessibility.
Testing strategy (Risk-Based, CSA-Friendly)
Start with unit tests of transforms and loaders. Then do a dry-run in a representative environment with production-like data. Use scripted steps for known risks and exploratory checks to surface surprises.
Sampling guidance
- 100% checks for identity fields and signature linkages
- 100% referential integrity checks
- Risk-based statistical sampling for non-critical attributes
Negative tests
- Overlength values
- Illegal or hidden characters
- Unexpected code sets
- Duplicate keys
- Time zone edge cases
Design your data reconciliation report to summarize record counts, hash totals for key numerics, outlier analysis, exceptions, and remediation. This is often the first artifact an inspector asks to see.
Handling Exceptions, Deviations, and Change Control
Define how you log defects, triage root cause, correct source data or mappings, and re-run loads. Tie remediation to formal change requests with impact assessments. Explain when you will re-execute a full test versus a targeted re-test. Keep a clean chain from defect to fix to evidence.
Final Verification and Sign-Off Package
Your closing report should read like a concise story of the project. Include scope, risk summary, mapping and transforms, executed evidence, reconciliation results, deviations and impact, residual risk, a plain-language statement that record meaning is preserved, and a go-live decision.
Describe the archive and retrieval strategy for legacy data. If full functionality cannot be preserved, justify your file formats and the access method. Inspectors look for a practical, risk-based approach that still protects integrity.
Special Cases You Should Plan For
Migrating E-Signatures and Approvals
Map signer identity, signing reason, date and time including time zone, and signature meaning. Show equivalence or justify read-only access that retains trustworthiness and legal effect under Part 11.
Attachments and Unstructured Content
Inventory attachments by type and size. Confirm readability in target viewers and preserve links back to the parent record.
Time Zone and Locale Changes
Normalize timestamps to a clear rule. Prove you did not shift clinical or batch chronology.
Partial Migrations and Coexistence
Document which records move, which stay, and how users will find the full history during the coexistence period.
What Inspectors Actually Ask?
- “Show me where you covered Annex 11 §4.8 on value or meaning.”
Point to your mapping verification, integrity checks, and negative tests. - “How did you protect trustworthiness and reliability of e-records and signatures?”
Show Part 11 controls for identity, security, and auditability before, during, and after migration. - “If you did not migrate audit trails, how will we review them?”
Demonstrate validated read-only access and retrieval instructions. - “What did you check 100%, and what did you sample?”
Explain your risk logic and show the results in the reconciliation summary. - “How will you keep the data usable for the long term?”
Reference MHRA and PIC/S expectations for accessibility and integrity.
Acceptance Criteria You Can Lift Into Your Protocol
- Identity, primary keys, cross-record links: 100% match between source and target
- Controlled vocabularies: 100% valid mapping or documented, risk-justified default
- Numeric and date fields: No truncation, rounding within predefined tolerance, time zone conversions verified against a reference table
- Audit trails: Migrated with event equivalence or kept read-only in the legacy system with documented access and retrieval steps
What Belongs in the Data Reconciliation Report
| Section | What to include | Why it matters |
| Record counts | Counts by object and status | Proves completeness |
| Hash totals | Key numerics by object | Detects silent drift |
| Sampling summary | Random and risk-based results | Shows breadth and depth |
| Orphaned or duplicate analysis | Parents without children, duplicate keys | Protects traceability |
| Exceptions log | Root cause, corrective actions, re-run outcomes | Closes the loop |
Use this same structure for interim dry-runs and your final package.
Data Migration Planning Checklist
- Business scope, in-scope and out-of-scope entities
- Data classification and criticality
- Source and target versions and schemas
- Mapping table with transforms and code sets
- Data quality rules and pre-cleansing plan
- Test datasets and anonymization method
- Backup, restore, and rollback plan
- Reconciliation math and thresholds
- Exception handling and re-migration process
- Post-go-live monitoring and Periodic Review schedule
Annex 11 Data Migration: What is Changing
The EU opened a consultation on revising Chapter 4 and Annex 11 on July 7, 2025, with language that reinforces lifecycle thinking, supplier oversight, and data integrity. Watch for final text and effective dates before you change procedures. For now, Annex 11 Revision 1 and the existing data integrity guidances remain the operative baseline.
Tip: Track consultation updates on the EudraLex Volume 4 site.
FAQ
What does Annex 11 require for migration?
Annex 11 §4.8 requires checks that data are not altered in value or meaning during migration. Your evidence should connect mapping verification, integrity checks, and reconciliation to that requirement.
Do audit trails have to be migrated?
No single rule. You can migrate them and show event equivalence, or keep the legacy system read-only and validated for retrieval. Either way, show access controls and how inspectors can review events.
How much sampling is acceptable?
Use risk-based sampling for non-critical attributes. Do 100% checks for identity fields, signature linkages, and all referential integrity. Document the rationale and outcomes.
What belongs in a reconciliation report?
Counts by object and status, hash totals for key numerics, risk-based samples with defect logs, orphaned or duplicate analysis, and exception handling with re-run results.How do we validate migrations to SaaS systems?
Add supplier assessment, export and API controls, security and access reviews, and a tested data export plan. Show how you will retrieve complete records on demand under Part 11.
