Data Integrity – Qvents

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Discussion forum for Pharma Quality events, Regulatory Actions

Warning letters, 483s, Recalls, Import Alerts, Audit observations

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Updated on October 11, 2023

Updated on October 11, 2023

USFDA Data Integrity and Compliance with Drug CGMP Questions and Answers – USFDA Guidance for Industry
EMA (European Medicines Agency) Data Integrity Aug 2016 (European Medicines Agency)
MHRA (Medicines & Healthcare products Regulatory Agency) ‘GXP’ Data Integrity Guidance and Definitions
WHO TRS 1033 – Annex 4: WHO Guideline on Data Integrity
PIC/S Guidance on Data Integrity; Good Practices For Data Management And Integrity In Regulated Gmp/Gdp Environments
Comparison of EMA and FDA Guidance on Data Management and Data Integrity; Barbara W. Unger; Redica Systems
Data Integrity checklist by Agilent (Useful checklist).

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