Glossary
Data Integrity
The degree to which data stays complete, consistent, accurate, and trustworthy from creation to disposal.
Source · WHO Quality Assurance of Medicines Terminology Database; WHO guideline on data integrity
Details
Data integrity is the state in which data remains complete, consistent, accurate, and trustworthy across the whole lifecycle and keeps the ALCOA+ attributes. The central inspection findings are missing raw data or metadata, shared accounts, selective reporting, deletion and reprocessing traces that were never reviewed, and backups whose restoration was never tested. Check data governance, the system inventory, privileges and audit trails, raw data review, and retention, backup, and recovery evidence.
Related sections
Related terms
Real inspection findings
Findings from regulators' inspection documents in which this term appears.
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Of these, one was classified as critical and found in the area of data integrity controls in the QC laboratory.
EMA · EU GMP NCR (EudraGMDP) · 2024-03-06 -
Significant data integrity gaps in the QC laboratory were of critical concern, demonstrating a failure to ensure traceability, security, and control of electronic data.
EMA · EU GMP NCR (EudraGMDP) · 2025-09-10 -
Critical data integrity issues were observed, undermining the reliability of manufacturing and quality control data.
EMA · EU GMP NCR (EudraGMDP) · 2026-05-04
Counted as of 2026-09-24 — the search you land on shows today's figures, so it may differ slightly.
Source
WHO Quality Assurance of Medicines Terminology Database; WHO guideline on data integrityGRM Regulatory Glossary
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