Data Integrity

Data Migration

What a definition is not

A definition is SPEQ’s plain-language decode of how a term is used in practice, cited to the documents that define it. It is a practitioner reference, not legal or regulatory advice, it does not replace the definition in the source, and where a regulator’s wording differs the regulator’s wording governs.

The validated transfer of electronic records and their associated metadata from one computerized system, file format, or storage medium to another — planned, executed, and verified so that no data is lost, altered, or rendered unreadable, and the migrated record remains a complete and accurate representation of the original.

Data migration happens whenever a system is replaced, upgraded, or decommissioned while the records it holds still need to survive — moving a laboratory information system to a new platform, or consolidating several legacy databases into one. It is a change with direct data integrity consequences, not a routine IT task.

A validated migration defines, in advance, exactly which records and which metadata, not just the visible data but audit trails, timestamps, and version history, will move, verifies a sample or full set of migrated records against the source before the old system is retired, and documents any records that could not be migrated and why.

A common failure mode is migrating the visible result while leaving the audit trail and metadata behind, or converting a record into a format that looks the same on screen but has lost the underlying data structure that made it a true copy of the original — both are treated as data integrity failures, not acceptable technical trade-offs.

KEY POINTS
  • A validated, planned transfer, not an informal copy-and-convert exercise
  • Must move metadata and audit trail alongside the visible data, not just the data
  • Migrated records are verified against the source before the old system is retired
  • Records that cannot be migrated must be documented, with a plan for their continued accessibility
REGULATORY BASIS

EU GMP Annex 11; PIC/S PI 041-1; GAMP 5 (data migration guidance)

Frequently asked questions

What is Data Migration?

The validated transfer of electronic records and their associated metadata from one computerized system, file format, or storage medium to another — planned, executed, and verified so that no data is lost, altered, or rendered unreadable, and the migrated record remains a complete and accurate representation of the original.

Which regulations cover Data Migration?

EU GMP Annex 11; PIC/S PI 041-1; GAMP 5 (data migration guidance)