GxP Digital Atlas

Tool: Timeline Maps

Every dated event, from the earliest to the latest expected, with one row per item so you can follow each document from start to finish.

How to read this page

Details: Guide Definitions: every term and label explained

Chronological map

Status / Category Filters & Settings
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One row per item, A to Z, grouped by authority. Select a row or marker to focus on it, double-click to open the item, or right-click (press and hold on a touch screen) for options. Click empty space or press Esc to clear.

Markers and lines

  • Solid marker: a dated event
  • Dashed diamond: a target, expected and not a fact
  • Solid line: the steps of one version
  • Dashed line: an older version leading to its replacement

Select one or more colours to highlight them and filter the events below. Status applies to each event. Select again to clear.

Status

Category and Sub Category

Medical Device Items

TitleCategorySub CategoryPurpose
EU · EC / EMA (11)
EC Annex 11CSV & Data IntegrityAnnexThe EU's main GMP rulebook for computerised systems. It sets out how systems used in making medicines must be validated, secured and controlled.
EC Annex 15Quality foundationsAnnexThe EU's GMP rules on qualifying equipment and validating manufacturing processes.
EC Annex 22 · AIAIAnnexA proposed new EU GMP annex on using AI models in medicine manufacturing. It would be the first EU GMP text written for AI, and is still a draft.
EC Chapter 1Quality foundationsChapterThe EU's GMP rules on the pharmaceutical quality system, which is the framework a manufacturer uses to manage quality.
EC Chapter 4Data IntegrityChapterThe EU's GMP rules on documentation. It explains which records a manufacturer must keep and how to keep them reliable.
EMA AI reflection paperAIGuidelineEMA's thinking on using AI across a medicine's life, from discovery to after approval. It is a reflection paper, so it is not a binding rule.
EMA CS clinical trialsCSV & Data IntegrityGuidelineEMA's guideline on computerised systems and electronic data in clinical trials, such as audit trails, cloud services and vendor agreements.
EMA GMP Q&A: IT and DICSV & Data IntegrityQuestions and answersQuestions and answers from EU inspectors explaining how they read Annex 11 and data integrity in practice.
EMA notice: CS in trialsCSVGuidanceA reminder from EMA that clinical trial sponsors must be able to show their computerised systems are validated, even when vendors supply them.
EU AI ActAIRegulationThe EU's general law on artificial intelligence, covering all sectors. What it requires depends on the risk of the AI system and the role of the company.
HMA-EMA AI workplanAIGuidanceThe plan for how EU medicines regulators will use and oversee AI up to 2028. It shows direction and creates no duties for companies.
PIC/S · ICH · ISPE (9)
ICH E6(R3) GCPQuality foundationsGuidelineThe international guideline on good clinical practice, the standard for running clinical trials. This version adds a section on data governance.
ICH Q10Quality foundationsGuidelineThe international model for a pharmaceutical quality system across a product's life. It builds on GMP.
ICH Q9(R1)Quality foundationsGuidelineThe international guideline on quality risk management. It explains how to find, assess and control risks to medicine quality.
ISPE GAMP 5, 2nd ed.CSVIndustry guideThe industry's best-known guide to a risk-based way of validating GxP computerised systems. It is good practice, not law.
ISPE GAMP Records & DI guideData IntegrityIndustry guideThe industry's guide to records and data integrity. It is good practice, not law.
PIC/S GMP Guide PE 009Quality foundationsGuidelineThe GMP guide used by inspectors in many countries. It closely follows the EU GMP Guide, so it sets a shared baseline for manufacturers.
PIC/S PI 006-4Quality foundationsGuidelinePIC/S recommendations for inspectors on qualification and validation, supporting Annex 15 of the PIC/S Guide.
PIC/S PI 011-3CSVGuidelineGuidance written for inspectors on computerised systems. Companies read it to see what inspectors are trained to look for.
PIC/S PI 041-1Data IntegrityGuidanceGuidance written for inspectors on keeping data reliable in GMP and GDP work. Companies read it to see what inspectors look for.
US · FDA (13)
FDA 21 CFR Part 11CSV & Data IntegrityRegulationThe US rule that says when FDA accepts electronic records and signatures in place of paper and handwritten ones.
FDA 21 CFR Part 211Quality foundationsRegulationThe US rules for making finished medicines, known as drug CGMP. Section 211.68 is the part that covers computers and automated equipment.
FDA AI guidance (drugs)AIGuidanceFDA's draft guidance on showing an AI model can be trusted when it supports decisions about a drug's safety, effectiveness or quality.
FDA BA/BE data integrityData IntegrityGuidanceFDA's draft guidance on keeping data reliable in bioavailability and bioequivalence studies, which compare how the body takes up a drug.
FDA blood system validationCSVGuidanceFDA's guidance on validating the computer systems that blood establishments use. It is also a compact example of a validation plan.
FDA CPG 425 seriesCSVGuidanceEarly FDA policy guides on computers in drug manufacturing. They explain how the drug GMP rules apply to hardware and software.
FDA CSA guidanceMedical Device Item Related to CSVCSVGuidanceFDA's guidance on checking software used in device production and quality systems. It asks for effort that matches the risk, not paperwork for its own sake.
FDA data integrity Q&AData IntegrityQuestions and answersFDA's questions and answers on keeping drug manufacturing data reliable, covering topics like audit trails and shared logins.
FDA electronic systems Q&ACSV & Data IntegrityQuestions and answersFDA's questions and answers on electronic systems, records and signatures used in clinical trials.
FDA Part 11 scope guidanceCSV & Data IntegrityGuidanceFDA's explanation of how it reads Part 11 in practice, including where it uses discretion and which records are covered.
FDA quality systems guideQuality foundationsGuidanceFDA's guidance showing how a modern quality system fits with the US drug GMP rules.
FDA software validationMedical Device Item Related to CSVCSVGuidanceFDA's long-standing guidance on the general principles of validating software, mainly for medical devices.
FDA–EMA AI principlesAIPrinciplesTen high-level principles agreed by FDA and EMA for using AI well across a medicine's life. They are not binding.
Warning letters and close-outs (18)
FDA AI warning letterAIEnforcementAn FDA warning letter to one firm that used AI to write GMP documents without proper review. It shows how FDA applies existing rules to AI.
FDA Allay WL 2021CSV & Data IntegrityEnforcementAn FDA warning letter to one firm, which did not assess the risk of having no audit trail controls and unique user passwords.
FDA Aspen WL 2025CSV & Data IntegrityEnforcementAn FDA warning letter to one firm, which did not review electronic raw data and audit trails before releasing batches.
FDA BBC Group WL 2021CSV & Data IntegrityEnforcementAn FDA warning letter to one firm, whose laboratory system lacked restricted access and had audit trails switched off.
FDA Chromatography Inst. WL 2025CSV & Data IntegrityEnforcementAn FDA warning letter to a testing laboratory, for weak laboratory controls and computer system vulnerabilities it had not assessed.
FDA Curia WL 2026CSV & Data IntegrityEnforcementAn FDA warning letter to one firm, where staff shared usernames and passwords for a system used for GMP analysis.
FDA Intas WL 2023CSV & Data IntegrityEnforcementAn FDA warning letter to one firm, where original records were destroyed and electronic batch records could be changed.
FDA Jaloma WL 2026CSV & Data IntegrityEnforcementAn FDA warning letter to one firm, for incomplete laboratory records and weak controls over changes to computer data.
FDA Jost Chemical WL 2022CSV & Data IntegrityEnforcementAn FDA warning letter to one firm, which had no procedures for its quality unit to review audit trails.
FDA Landy WL 2024CSV & Data IntegrityEnforcementAn FDA warning letter to one firm, where staff shared a password kept in a drawer, on a system with no audit trail.
FDA Lex WL 2023CSV & Data IntegrityEnforcementAn FDA warning letter to one firm, where laboratory staff held administrator rights and data changes could not be traced.
FDA Medgel WL 2023Data IntegrityEnforcementAn FDA warning letter to one firm, whose raw humidity data was not backed up and was deleted every month.
FDA Missouri Analytical WL 2021CSV & Data IntegrityEnforcementAn FDA warning letter to a testing laboratory, where deleted data files and falsified records were found.
FDA MMC Healthcare WL 2024CSV & Data IntegrityEnforcementAn FDA warning letter to one firm, with backdated validation reports and a laboratory system with no audit trail.
FDA Nortec WL 2022CSV & Data IntegrityEnforcementAn FDA warning letter to one firm, where over 100 deleted files were found on instrument computers.
FDA Sanitor WL 2021CSV & Data IntegrityEnforcementAn FDA warning letter to one firm, whose laboratory system could not prevent deletion of raw data.
FDA Ultra Seal WL 2022CSV & Data IntegrityEnforcementAn FDA warning letter to one firm, whose laboratory audit trails showed deleted and aborted work with no recorded reason.
FDA Vi-Jon WL 2022CSV & Data IntegrityEnforcementAn FDA warning letter to one firm, where deleted files were found on a computer and audit trails were not reviewed before batch release.
UK · MHRA (2)
MHRA AI regulation paperAIGuidanceThe UK regulator's paper on how it applies the government's AI principles to medicines and medical devices. It is policy, not a rule.
MHRA GxP data integrityData IntegrityGuidanceThe UK regulator's guidance on data integrity across GxP work. Its clear definitions make it a popular starting point for learning the subject.
Other national (4)
Health Canada GUI-0050CSV & Data IntegrityAnnexCanada's guidance on computerised systems, adopted directly from Annex 11 of the PIC/S GMP Guide, with Canadian terms.
NMPA AI opinionsAIGuidanceChina's plan for how regulators will use AI in their own work on medicines, such as review and inspection. It is aimed at regulators, not companies.
PMDA Japan CS guidelineCSVGuidelineJapan's guideline on computerised systems for drug manufacturers, covering a system's life from development to retirement.
PMDA Japan PIC/S GMP noticeQuality foundationsGuidanceA Japanese notice introducing the PIC/S GMP Guide as guidance for GMP at manufacturing sites.

Time runs left to right. Each year from 2020 is drawn wider, because that is where most events fall. How to read the timeline · What each Category means

All 107 events

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