Glossary

Data Retention

Controls that keep data and metadata secure, readable, and retrievable for the statutory and GMP retention period.

Details

Data retention must prevent alteration and loss while keeping accessibility, readability, and context for the whole period. Inspections cite raw data that became inaccessible after equipment replacement or software retirement, retention periods that do not agree with each other, disposal without approval, and inadequate verification of true copies. Check the retention policy and inventory, system end of life plans, archive retrieval testing, disposal approvals, and the mapping to statutory periods.

Related sections

MHRA GxP Data Integrity Guidance §6.17EU GMP Annex 11 §§7, 17

Related terms

Archiving / Archive1 casesBack-up2 casesData Lifecycle

Real inspection findings

Findings from regulators' inspection documents in which this term appears.

  1. Failure to maintain complete data derived from all testing and to ensure compliance with established specifications and standards pertaining to data retention and management, Specifically, © 1.
    FDA · FDA 483 · 2017-05-11
  2. Failure to maintain complete data derived from all testing and to ensure compliance with established specifications and standards pertainng to data retention and management.
    FDA · FDA 483 · 2019-04-30
See 2 findings that mention this term

Source

MHRA GxP Data Integrity Guidance (2018), §6.17 Data retention
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