Details: Change Log · Life Science & Pharma: GxP - CSV & Data Integrity
Dated changes for Life Science & Pharma: GxP - CSV & Data Integrity, newest first. Targets and routine checks are left out.
Corrections
Correction (SME Reviewer) means this site's own record was wrong, and the regulator changed nothing. Correction (Authority) means the regulator corrected its own document. Date is the date of the correction, or the date it was flagged if it is still under review.
| Date | Change Type | Nature of Correction | Reason for Correction | Impact on Item Record |
|---|---|---|---|---|
| Corrected 2 Nov 2026 | Correction (SME Reviewer) | FDA 21 CFR Part 11: the entry dated 5 Sep 2003 recorded an update to the regulation. It has been withdrawn from the item's status history and timeline, and kept in the change log. | The entry recorded the publication of FDA's guidance "Part 11, Electronic Records; Electronic Signatures — Scope and Application" as an update to Part 11. That guidance explains how FDA interprets and applies the regulation. It does not amend the regulation, and the text of Part 11 did not change on that date. The publication was also already recorded under the guidance's own item, so the event appeared twice. The error was in this site's own data. FDA's records were correct. | Corrected |
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Date
Area
Regulator
Change Type
Status
Category and Sub Category
Medical Device Items
2026 (7)
- 29 Oct 2026UpdatedEMA notice: CS in trials: Revision 1: administrative update of referencesFinalCSV · Guidance
- 1 Oct 2026PublishedPIC/S PI 006-4: Version PI 006-4 dated 1 Oct 2026FinalQuality foundations · Guideline
- 23 Sep 2026UpdatedPIC/S GMP Guide PE 009: PE 009-18 published (revised Annex 19, reference and retention samples); supersedes PE 009-17In forceQuality foundations · Guideline
- 18 Sep 2026Warning letterFDA Curia WL 2026: Warning letter issuedWarning letterCSV & Data Integrity · Enforcement
- 30 Jun 2026WorkshopEC Annex 22 · AI: EMA multistakeholder workshop on comments and generative AI (30 Jun–1 Jul)DraftAI · Annex
- 22 May 2026Warning letterFDA Jaloma WL 2026: Warning letter issuedWarning letterCSV & Data Integrity · Enforcement
- 3 Feb 2026UpdatedFDA CSA guidance: Updated and retitled for QMS software
Medical Device Item Related to CSVFinalCSV · Guidance
2025 (12)
- 7 Oct 2025Consultation closedEC Annex 11 revision: Public consultation closedDraftCSV & Data Integrity · Annex
- 7 Oct 2025Consultation closedEC Annex 22 · AI: Public consultation closedDraftAI · Annex
- 7 Oct 2025Consultation closedEC Chapter 4 revision: Public consultation closedDraftData Integrity · Chapter
- 24 Sep 2025PublishedFDA CSA guidance: Final guidance published
Medical Device Item Related to CSVFinalCSV · Guidance - 8 Sep 2025PublishedICH E6(R3) GCP: Published by FDA as final guidanceFinalQuality foundations · Guideline
- 3 Sep 2025Draft publishedEC Chapter 1 revision: Consultation document publishedDraftQuality foundations · Chapter
- 20 Aug 2025Warning letterFDA Chromatography Inst. WL 2025: Warning letter issuedWarning letterCSV & Data Integrity · Enforcement
- 7 Jul 2025Consultation openEC Annex 11 revision: Draft published for public consultationDraftCSV & Data Integrity · Annex
- 7 Jul 2025Consultation openEC Annex 22 · AI: Draft published for public consultationDraftAI · Annex
- 7 Jul 2025Consultation openEC Chapter 4 revision: Draft published for public consultationDraftData Integrity · Chapter
- 22 May 2025Close-outFDA Medgel WL 2023: Close-out letter issuedWarning letter (closed)Data Integrity · Enforcement
- 24 Feb 2025Warning letterFDA Aspen WL 2025: Warning letter issuedWarning letterCSV & Data Integrity · Enforcement
2024 (7)
- 9 Oct 2024Close-outFDA Missouri Analytical WL 2021: Close-out letter issuedWarning letter (closed)CSV & Data Integrity · Enforcement
- 1 Oct 2024PublishedFDA electronic systems Q&A: Final guidance issued (October 2024)FinalCSV & Data Integrity · Questions and answers
- 25 Sep 2024Close-outFDA Ultra Seal WL 2022: Close-out letter issued, for Ultra Seal Corporation FEI 1317759Warning letter (closed)CSV & Data Integrity · Enforcement
- 24 Sep 2024Warning letterFDA MMC Healthcare WL 2024: Warning letter issuedWarning letterCSV & Data Integrity · Enforcement
- 12 Jun 2024Warning letterFDA Landy WL 2024: Warning letter issuedWarning letterCSV & Data Integrity · Enforcement
- 3 Apr 2024Draft publishedFDA BA/BE data integrity: Draft guidance issuedDraftData Integrity · Guidance
- 8 Mar 2024Close-outFDA Vi-Jon WL 2022: Close-out letter issuedWarning letter (closed)CSV & Data Integrity · Enforcement
2023 (8)
- 23 Oct 2023Close-outFDA Nortec WL 2022: Close-out letter issuedWarning letter (closed)CSV & Data Integrity · Enforcement
- 17 Aug 2023Warning letterFDA Lex WL 2023: Warning letter issuedWarning letterCSV & Data Integrity · Enforcement
- 28 Jul 2023Warning letterFDA Intas WL 2023: Warning letter issuedWarning letterCSV & Data Integrity · Enforcement
- 20 Jul 2023Warning letterFDA Medgel WL 2023: Warning letter issuedWarning letterData Integrity · Enforcement
- 10 Mar 2023PublishedEMA CS clinical trials: Final version publishedFinalCSV & Data Integrity · Guideline
- 10 Mar 2023SupersededEMA eSource paper (2010): Replaced by the 2023 guidelineSupersededData Integrity · Guideline
- 7 Mar 2023AdoptedEMA CS clinical trials: Final version adopted by the GCP Inspectors Working GroupFinalCSV & Data Integrity · Guideline
- 18 Jan 2023AdoptedICH Q9(R1): Reached Step 4 (final)FinalQuality foundations · Guideline
2022 (8)
- 8 Dec 2022Warning letterFDA Nortec WL 2022: Warning letter issuedWarning letterCSV & Data Integrity · Enforcement
- 16 Nov 2022Concept paperEC Annex 11 revision: Concept paper on revising Annex 11 (EMA/INS/GMP/778340/2022)ConceptCSV & Data Integrity · Annex
- 13 Sep 2022Draft publishedFDA CSA guidance: Draft guidance published
Medical Device Item Related to CSVDraftCSV · Guidance - 29 Jul 2022PublishedISPE GAMP 5, 2nd ed.: Second edition published (29 Jul 2022)Industry guideCSV · Industry guide
- 18 Jul 2022Close-outFDA Allay WL 2021: Close-out letter issuedWarning letter (closed)CSV & Data Integrity · Enforcement
- 18 Jul 2022Warning letterFDA Jost Chemical WL 2022: Warning letter issuedWarning letterCSV & Data Integrity · Enforcement
- 31 Mar 2022Warning letterFDA Vi-Jon WL 2022: Warning letter issuedWarning letterCSV & Data Integrity · Enforcement
- 14 Mar 2022Warning letterFDA Ultra Seal WL 2022: Warning letter issuedWarning letterCSV & Data Integrity · Enforcement
2021 (9)
- 17 Dec 2021Consultation closedEMA CS clinical trials: Public consultation closedDraftCSV & Data Integrity · Guideline
- 29 Nov 2021Warning letterFDA Sanitor WL 2021: Warning letter issuedWarning letterCSV & Data Integrity · Enforcement
- 18 Nov 2021Draft publishedICH Q9(R1): Q9(R1) released for public consultation at Step 2DraftQuality foundations · Guideline
- 30 Sep 2021Warning letterFDA Missouri Analytical WL 2021: Warning letter issuedWarning letterCSV & Data Integrity · Enforcement
- 10 Aug 2021PublishedHealth Canada GUI-0050: PublishedFinalCSV & Data Integrity · Annex
- 4 Aug 2021Warning letterFDA BBC Group WL 2021: Warning letter issuedWarning letterCSV & Data Integrity · Enforcement
- 1 Jul 2021PublishedPIC/S PI 041-1: Final version publishedFinalData Integrity · Guidance
- 18 Jun 2021Consultation openEMA CS clinical trials: Public consultation startedDraftCSV & Data Integrity · Guideline
- 27 Jan 2021Warning letterFDA Allay WL 2021: Warning letter issuedWarning letterCSV & Data Integrity · Enforcement
2020 (1)
- 7 Apr 2020PublishedEMA notice: CS in trials: First publishedFinalCSV · Guidance
2018 (3)
- ~1 Dec 2018PublishedFDA data integrity Q&A: Final guidance published (Dec 2018)FinalData Integrity · Questions and answers
- 4 Apr 2018UpdatedMHRA GxP data integrity: Earlier GMP guidance withdrawn, replaced by this GxP guidanceFinalData Integrity · Guidance
- 9 Mar 2018PublishedMHRA GxP data integrity: PublishedFinalData Integrity · Guidance
2017 (1)
- ~1 Mar 2017PublishedISPE GAMP Records & DI guide: Published (March 2017)Industry guideData Integrity · Industry guide
2015 (3)
- 1 Oct 2015In operationEC Annex 15: Came into operationIn forceQuality foundations · Annex
- 13 Mar 2015UpdatedMHRA GxP data integrity: Earlier GMP guidance updated with clarificationsFinalData Integrity · Guidance
- 23 Jan 2015PublishedMHRA GxP data integrity: Earlier GMP data integrity definitions and guidance first publishedFinalData Integrity · Guidance
2013 (2)
- ~1 Apr 2013PublishedFDA blood system validation: Final guidance issued (April 2013)FinalCSV · Guidance
- 31 Jan 2013In operationEC Chapter 1 (2013): Came into operationIn forceQuality foundations · Chapter
2012 (1)
- 1 Feb 2012PublishedPMDA Japan PIC/S GMP notice: Administrative notice issuedFinalQuality foundations · Guidance
2011 (5)
- 30 Jun 2011In operationEC Annex 11 (2011): Came into operationIn forceCSV & Data Integrity · Annex
- 30 Jun 2011In operationEC Chapter 4 (2011): Came into operationIn forceData Integrity · Chapter
- ~1 Feb 2011PublishedEMA GMP Q&A: IT and DI: Annex 11 questions dated February 2011FinalCSV & Data Integrity · Questions and answers
- ~1 Jan 2011PublishedEC Annex 11 (2011): Revision 1 published in EudraLex Volume 4 (January 2011)FinalCSV & Data Integrity · Annex
- ~1 Jan 2011PublishedEC Chapter 4 (2011): Revision 1 published in EudraLex Volume 4 (January 2011)FinalData Integrity · Chapter
2010 (3)
- 21 Oct 2010PublishedPMDA Japan CS guideline: Notification No. 1021-11 issuedFinalCSV · Guideline
- 1 Aug 2010In operationEMA eSource paper (2010): Came into effectFinalData Integrity · Guideline
- 9 Jun 2010AdoptedEMA eSource paper (2010): Adopted by the GCP Inspectors Working GroupFinalData Integrity · Guideline
2009 (1)
- 8 Apr 2009PublishedICH Q10: Published by FDA as guidanceFinalQuality foundations · Guideline
2007 (1)
- 25 Sep 2007UpdatedPIC/S PI 011-3: Version PI 011-3 dated 25 Sep 2007FinalCSV · Guideline
2006 (1)
- 2 Oct 2006PublishedFDA quality systems guide: Final guidance issuedFinalQuality foundations · Guidance
2005 (1)
- 9 Nov 2005PublishedICH Q9(R1): Original Q9 reached Step 4FinalQuality foundations · Guideline
2003 (3)
- 5 Sep 2003Correction (SME Reviewer)FDA 21 CFR Part 11: FDA issued its Scope and Application guidance (Sep 2003); Part 11 remains in effect
Correction (SME Reviewer), 2 Nov 2026. This repeated the scope guidance's own event. A guidance does not update a regulation, and Part 11 did not change on this date.In forceCSV & Data Integrity · Regulation - 5 Sep 2003PublishedFDA Part 11 scope guidance: Final guidance issuedFinalCSV & Data Integrity · Guidance
- 1 Sep 2003In forcePIC/S PI 011-3: Entered into forceFinalCSV · Guideline
2002 (1)
- 11 Jan 2002PublishedFDA software validation: Version 2.0 issued, superseding the 1997 draft
Medical Device Item Related to CSVFinalCSV · Guidance
1997 (3)
- 20 Aug 1997In forceFDA 21 CFR Part 11: EffectiveIn forceCSV & Data Integrity · Regulation
- 9 Jun 1997Draft publishedFDA software validation: Draft version 1.1 dated 9 Jun 1997
Medical Device Item Related to CSVDraftCSV · Guidance - ~1 Mar 1997PublishedFDA 21 CFR Part 11: Final rule issued (March 1997)FinalCSV & Data Integrity · Regulation
1987 (1)
- 4 Sep 1987UpdatedFDA CPG 425 series: Sec. 425.100 revisedFinalCSV · Guidance
1984 (1)
- 19 Oct 1984PublishedFDA CPG 425 series: Sec. 425.100 originally issuedFinalCSV · Guidance
1978 (1)
- 29 Sep 1978PublishedFDA 21 CFR Part 211: Published at 43 FR 45077In forceQuality foundations · Regulation