Life Science & Pharma: GxP - CSV & Data Integrity
Part 11, Annex 11 and its revision, Chapter 4, and data integrity guidance from FDA, MHRA and PIC/S, ICH Q9(R1), GAMP 5 and FDA warning letters.
- Documents
- 53
- Authorities
- European Commission, PIC/S, ICH, FDA, MHRA, ISPE, EMA, Health Canada, PMDA
- Legal weight
- Law & regulation, GMP guide & annexes, Guidance & Q&A, Industry good practice, Warning letters
- Links on the map
- 46
- Crosswalks
- 5
- Next expected
- Target 31 Dec 2026: Annex 11 revision
How to read this page
- 1. Scan across to see who issued each document, then down to see how binding it is, from law at the top to industry practice at the bottom.
- 2. Read the card: colour and words show status. Point at it for its full title and a plain explanation.
- Settings: open Status / Category Filters & Settings above the map for zoom, the keys, and Colour by.
- Colour by: switch the cards between Status and Category. In Category mode each Category has one colour, each Sub Category is a shade of it, and a card with two colours belongs to a combined Category.
- Filter with the keys: in the same panel, select one or more colours to highlight their cards and filter the crosswalks, instruments and relations below. Choices in a group widen the results, and Status and Category narrow each other. Counts in titles follow the filter. Select again to clear.
- Jump around: the bar under Latest in this area takes you to the map, crosswalks, instruments and relations.
- 3. Focus on a card: select it to fade everything else and list its links beside the map. Double-click to open the item, or right-click (press and hold on a touch screen) for options to open, compare or clear. Click empty space or press Esc to clear. Select a line to compare two documents.
- 4. Check clause by clause: crosswalks sit just below the map.
- Prefer text? The table and the list of relations give the same information, and work with a keyboard or screen reader.
- Red and green cards at the foot of the map are selected FDA warning letters, not rules. The window is 10 years, reflecting the potential lifecycle of a product. Current FDA data available via the automated system is limited to 2021 onwards. Note that this is dependent upon the FDA and thus may be impacted intermittently and historically regarding the list of related warning/close-out letters. Light green with (closed) means FDA issued a close-out letter.
- Unverified link means the SME Reviewer has not yet confirmed that link.
Start with
The most connected documents in this area, so a good place to begin.
- Annex 11 (2011) In force 6 links. The current EU GMP annex for computerised systems used in GMP-regulated activities.
- Annex 15 In force 6 links. The EU GMP annex on qualification and validation.
- ICH Q9(R1) Final 6 links. The international guideline on quality risk management.
- Annex 11 revision Draft 5 links. A full rewrite of Annex 11, published for consultation with the revised Chapter 4 and the new Annex 22.
- Part 11 scope guidance Final 5 links. FDA guidance on how it applies Part 11.
- PIC/S GMP Guide PE 009 In force 5 links. The PIC/S GMP guide used by participating inspectorates, including an annex on computerised systems equivalent to EU Annex 11.
Latest in this area
The five newest dated changes. All changes in this area · Timeline
- 29 Oct 2026EMA notice: CS in trials: Revision 1: administrative update of referencesFinal
- 1 Oct 2026PIC/S PI 006-4: Version PI 006-4 dated 1 Oct 2026Final
- 23 Sep 2026PIC/S GMP Guide PE 009: PE 009-18 published (revised Annex 19, reference and retention samples); supersedes PE 009-17In force
- 18 Sep 2026Curia WL 2026: Warning letter issuedWarning letter
- 30 Jun 2026Annex 22 · AI: EMA multistakeholder workshop on comments and generative AI (30 Jun–1 Jul)Draft
All 53 instruments
Weight means how binding the document is. Weight explained
Map
Status / Category Filters & Settings
Lines
- Solid: interprets, implements, complements and other links
- Dashed: replaces or will replace
- Dotted: informs
Cards
- Solid card: the lead authority
- Dashed card: a co-author of a joint publication
Select one or more colours to highlight them and filter the lists on this page. Select again to clear.
Status
Category and Sub Category
Medical Device Items
What each Category means · What each link means · What each status means
EU · EC / EMA (12)PIC/S · ICH · ISPE (9)US · FDA (28)UK · MHRA (1)Other national (3)Law & regulation
bindingGMP guide & annexes
binding in the EU via GMP directivesGuidance & Q&A
current thinking, not bindingIndustry good practice
cite onlyWarning letters
selected FDA letters, last 10 years. A flag, not a rule
bindingGMP guide & annexes
binding in the EU via GMP directivesGuidance & Q&A
current thinking, not bindingIndustry good practice
cite onlyWarning letters
selected FDA letters, last 10 years. A flag, not a rule
Crosswalks in this area
A crosswalk matches clauses in one document with clauses on the same topic in another. Open one to see it row by row. "None" means that document has no matching clause, and "Difference" is our own short note, not a legal comparison.
EU GMP Annex 11 (2011) ↔ Annex 11 revision (draft) 19 topics
Annex 11 (2011) compared with Annex 11 revision. Relationship types after NIST IR 8477 (STRM): equal, intersects, superset, subset, none. Drafted with AI from the official texts. Strength is a placeholder and is hidden until the SME Reviewer has reviewed the mapping. The revision is a consultation draft and may change.
| Annex 11 (2011) | Topic | Annex 11 revision | Relationship | Difference |
|---|---|---|---|---|
| §1 | Risk management | §2.2, §4 | Subset | The draft gives risk management a full section, including identification, mitigation and data integrity. |
| §2 | Personnel and training | §5 | Subset | The draft adds a stated expectation of cooperation and training. |
| §3 | Suppliers and service providers | §2.6, §7 | Subset | The draft adds audit, oversight, documentation availability and contract detail. |
| §4 | Validation | §6, §9 | Intersects | The draft separates system requirements from qualification and validation. |
| §5 | Data exchange | §10.2 | Subset | The draft covers data transfer within a wider section on handling of data. |
| §6 | Accuracy checks | §10.1 | Intersects | The draft addresses input verification. |
| §7 | Data storage and backup | §16, §17 | Subset | The draft has separate sections for backup and archiving, including restore tests. |
| §8 | Printouts | None | No match | The draft has no section of this name. Check §12.9 on electronic copies and §13.6 on how signatures are displayed. |
| §9 | Audit trails | §12 | Subset | The draft adds detail on what is captured, who reviews, scope and timing of review. |
| §10 | Change and configuration management | §6.6 | Intersects | The draft has no separate section. Configuration sits under system requirements, and change control appears in the glossary. |
| §11 | Periodic evaluation | §14 | Subset | The draft sets out the scope and frequency of periodic reviews. |
| §12 | Security | §11, §15 | Subset | The draft splits this into identity and access management and a long security section. |
| §13 | Incident management | §14.2 | Intersects | The draft has no separate section. Incidents appear in periodic review and supplier reporting. |
| §14 | Electronic signature | §13 | Subset | The draft adds detail, including open systems, re-authentication and hybrid solutions. |
| §15 | Batch release | §12.8, §12.10 | Intersects | The draft mentions batch release when dealing with audit trail review and availability to the QP. |
| §16 | Business continuity | §15.7 | Intersects | The draft deals with this through a disaster recovery plan. |
| §17 | Archiving | §17 | Subset | The draft adds read-only storage, verification, durability and retrieval. |
| None | Alarms | §8 | No match | New section in the draft. |
| None | Link to the pharmaceutical quality system | §3 | No match | New section in the draft. |
EU GMP Chapter 4 (2011) ↔ Chapter 4 revision (draft) 10 topics
Chapter 4 (2011) compared with Chapter 4 revision. Relationship types after NIST IR 8477 (STRM): equal, intersects, superset, subset, none. Drafted with AI from the official texts. Strength is a placeholder and is hidden until the SME Reviewer has reviewed the mapping. The revision is a consultation draft and may change.
| Chapter 4 (2011) | Topic | Chapter 4 revision | Relationship | Difference |
|---|---|---|---|---|
| §4.1–4.6 | Generation and control of documentation | §4.49 onwards | Intersects | Same subject, renumbered in the draft. |
| §4.7–4.9 | Good documentation practice | §4.56 onwards | Subset | The draft sets out a table of data attributes, with an explanation of each. |
| §4.10–4.12 | Retention of documents | §4.76 onwards | Intersects | Same subject, renumbered in the draft. |
| Specifications, formula, instructions, records | Master documents | §4.27 onwards | Intersects | The draft groups these as master documents, with a non-exhaustive list. |
| None | Data governance systems | §4.10 onwards | No match | New section in the draft. |
| None | Risk management in documentation | §4.19 onwards | No match | New section in the draft. |
| None | General requirements for documentation | §4.23 onwards | No match | New section in the draft, linking documentation to the quality system. |
| None | Signatures in GMP documentation | §4.64 onwards | No match | New section in the draft. |
| None | Data integrity in documentation | §4.80 onwards | No match | New section in the draft. |
| None | Hybrid systems | §4.82 onwards | No match | New section in the draft. |
FDA data integrity Q&A ↔ MHRA GxP data integrity guidance 13 topics
FDA data integrity Q&A compared with MHRA GxP data integrity. Relationship types after NIST IR 8477 (STRM): equal, intersects, superset, subset, none. Drafted with AI from the official texts. Strength is a placeholder and is hidden until the SME Reviewer has reviewed the mapping. Both are guidance. The FDA document covers drug CGMP, and the MHRA document covers all GxP.
| FDA data integrity Q&A | Topic | MHRA GxP data integrity | Relationship | Difference |
|---|---|---|---|---|
| Q1 | Key terms | §6.1–6.4, §6.11 | Intersects | Both define terms. MHRA adds a wider definitions section. |
| Q2 | Excluding or invalidating results | §6.10 | Intersects | FDA deals with CGMP results. MHRA deals with excluding data generally, and not for GPvP. |
| Q3 | Validating workflows | §6.19 | Intersects | FDA asks about each workflow. MHRA deals with validation for intended purpose. |
| Q4, Q5 | Access and shared logins | §6.16 | Intersects | Both raise concerns on shared accounts and administrator rights. |
| Q6 | Control of blank forms | §6.7 | Intersects | FDA asks specifically about blank forms. MHRA addresses recording generally. |
| Q7, Q8 | Audit trail review | §6.13 | Intersects | Both address who reviews and how often. |
| Q9, Q10 | Copies and original records | §6.11 | Intersects | Both address true copies and static or dynamic records. |
| Q11 | Electronic signatures | §6.14 | Intersects | FDA asks about master production and control records. |
| Q16 | Training | §6.5 | Intersects | MHRA places training within data governance. |
| None | Data governance and culture | §3, §6.5 | No match | MHRA treats this as a subject in its own right. FDA has no matching question. |
| None | Data lifecycle | §6.6 | No match | No matching FDA question. |
| None | IT suppliers and cloud | §6.20 | No match | No matching FDA question. |
| Q13 | Sample use in system suitability | None | No match | FDA-specific laboratory question. |
21 CFR Part 11 ↔ EU GMP Annex 11 (2011) 10 topics
21 CFR Part 11 compared with Annex 11 (2011). Relationship types after NIST IR 8477 (STRM): equal, intersects, superset, subset, none. Strength 0-10.
| 21 CFR Part 11 | Topic | Annex 11 (2011) | Relationship | Difference |
|---|---|---|---|---|
| §11.10(a) | Validation | §4 | Intersects | Annex 11 adds inventory, URS traceability and supplier evidence |
| §11.10(b) | Accurate, complete copies | §8 | Intersects | Annex 11 frames it as printouts and change indication |
| §11.10(c) | Record protection and retrieval | §7, §17 | Intersects | Annex 11 splits storage/backup from archiving |
| §11.10(d) | Limiting system access | §12 | Intersects | Annex 11 adds physical security and access logging |
| §11.10(e) | Audit trails | §9 | Intersects | Annex 11 is risk-based and asks for a reason for change |
| §11.10(i) | Training and qualification | §2 | Intersects | Annex 11 names process owner and system owner roles |
| §11.50–11.300 | Electronic signatures | §14 | Superset | Part 11 prescribes components, linking and certification to FDA |
| None | Suppliers and service providers | §3 | No match | EU-only requirement |
| None | Periodic evaluation | §11 | No match | EU-only requirement |
| None | Business continuity | §16 | No match | EU-only requirement |
21 CFR 211.68 ↔ EU GMP Annex 11 (2011) 9 topics
21 CFR Part 211 compared with Annex 11 (2011). Relationship types after NIST IR 8477 (STRM): equal, intersects, superset, subset, none. Drafted with AI from the official texts. Strength is a placeholder and is hidden until the SME Reviewer has reviewed the mapping. This compares section 211.68 only, not the rest of Part 211.
| 21 CFR Part 211 | Topic | Annex 11 (2011) | Relationship | Difference |
|---|---|---|---|---|
| §211.68(a) | Routine calibration, inspection or checks | §4, §11 | Intersects | 211.68(a) asks for a written program of checks. Annex 11 uses validation and periodic evaluation. |
| §211.68(b) | Authorised changes to records | §9, §12 | Intersects | 211.68(b) limits changes to authorised people. Annex 11 adds access controls and audit trails. |
| §211.68(b) | Input and output checks | §5, §6 | Intersects | 211.68(b) bases checks on complexity and reliability. Annex 11 asks for built-in checks on data exchange and manual entry. |
| §211.68(b) | Backup of data | §7 | Intersects | Both require secure backup. Annex 11 adds checks that data can be restored. |
| §211.68(c) | Automation in place of a second person | §6 | Intersects | 211.68(c) allows it if conditions are met. Annex 11 addresses a second check on critical manual entry. |
| None | Suppliers and service providers | §3 | No match | Not addressed in 211.68. |
| None | Audit trails | §9 | No match | 211.68 does not use the term. FDA deals with audit trails in guidance. |
| None | Electronic signature | §14 | No match | In the US this is a Part 11 subject. |
| None | Incident management | §13 | No match | Not addressed in 211.68. |
Relationship key
- Equal
- The two clauses cover the same ground.
- Intersects
- They overlap, but each covers something the other does not.
- Superset
- The first document's clause covers everything in the second, and more.
- Subset
- The first document's clause covers only part of the second.
- No match
- One document has no matching clause.
Relations on this map
The same links as the lines above, in words. What each link means
- Annex 11 revision will replace Annex 11 (2011)· Compare Annex 11 revision and Annex 11 (2011) Unverified link
- Annex 22 · AI complements Annex 11 revision· Compare Annex 22 · AI and Annex 11 revision Unverified link
- Chapter 4 revision complements Annex 11 revision· Compare Chapter 4 revision and Annex 11 revision Unverified link
- Chapter 4 revision will replace Chapter 4 (2011)· Compare Chapter 4 revision and Chapter 4 (2011) Unverified link
- Annex 11 (2011) complements Chapter 4 (2011)· Compare Annex 11 (2011) and Chapter 4 (2011) Unverified link
- PIC/S GMP Guide PE 009 is the counterpart of Annex 11 (2011)· Compare PIC/S GMP Guide PE 009 and Annex 11 (2011) Unverified link
- FDA data integrity Q&A is related to 21 CFR Part 11· Compare FDA data integrity Q&A and 21 CFR Part 11 Unverified link
- ICH Q9(R1) is the risk basis for Annex 11 revision· Compare ICH Q9(R1) and Annex 11 revision Unverified link
- PIC/S PI 041-1 is related to MHRA GxP data integrity· Compare PIC/S PI 041-1 and MHRA GxP data integrity Unverified link
- Part 11 scope guidance interprets 21 CFR Part 11· Compare Part 11 scope guidance and 21 CFR Part 11 Unverified link
- FDA CPG 425 series interprets 21 CFR Part 211· Compare FDA CPG 425 series and 21 CFR Part 211 Unverified link
- EMA GMP Q&A: IT and DI interprets Annex 11 (2011)· Compare EMA GMP Q&A: IT and DI and Annex 11 (2011) Unverified link
- Chapter 1 revision will replace Chapter 1 (2013)· Compare Chapter 1 revision and Chapter 1 (2013) Unverified link
- EMA CS clinical trials replaces EMA eSource paper (2010)· Compare EMA CS clinical trials and EMA eSource paper (2010) Unverified link
- Health Canada GUI-0050 implements PIC/S GMP Guide PE 009· Compare Health Canada GUI-0050 and PIC/S GMP Guide PE 009 Unverified link
- Japan PIC/S GMP notice implements PIC/S GMP Guide PE 009· Compare Japan PIC/S GMP notice and PIC/S GMP Guide PE 009 Unverified link
- FDA quality systems guide interprets 21 CFR Part 211· Compare FDA quality systems guide and 21 CFR Part 211 Unverified link
- ICH Q10 complements ICH Q9(R1)· Compare ICH Q10 and ICH Q9(R1) Unverified link
- ICH Q10 complements Chapter 1 (2013)· Compare ICH Q10 and Chapter 1 (2013) Unverified link
- ICH Q10 complements Chapter 1 revision· Compare ICH Q10 and Chapter 1 revision Unverified link
- Annex 15 complements Annex 11 (2011)· Compare Annex 15 and Annex 11 (2011) Unverified link
- ICH Q9(R1) is the risk basis for Annex 15· Compare ICH Q9(R1) and Annex 15 Unverified link
- ICH Q10 is related to Annex 15· Compare ICH Q10 and Annex 15 Unverified link
- Annex 11 revision complements Annex 15· Compare Annex 11 revision and Annex 15 Unverified link
- Chapter 4 revision complements Annex 22 · AI· Compare Chapter 4 revision and Annex 22 · AI Unverified link
- FDA data integrity Q&A interprets 21 CFR Part 211· Compare FDA data integrity Q&A and 21 CFR Part 211 Unverified link
- ICH Q9(R1) is the risk basis for FDA data integrity Q&A· Compare ICH Q9(R1) and FDA data integrity Q&A Unverified link
- FDA data integrity Q&A is related to Part 11 scope guidance· Compare FDA data integrity Q&A and Part 11 scope guidance Unverified link
- ICH Q9(R1) is the risk basis for FDA quality systems guide· Compare ICH Q9(R1) and FDA quality systems guide Unverified link
- FDA electronic systems Q&A complements Part 11 scope guidance· Compare FDA electronic systems Q&A and Part 11 scope guidance Unverified link
- FDA electronic systems Q&A interprets 21 CFR Part 11· Compare FDA electronic systems Q&A and 21 CFR Part 11 Unverified link
- FDA BA/BE data integrity is related to ICH E6(R3) GCP· Compare FDA BA/BE data integrity and ICH E6(R3) GCP Unverified link
- FDA BA/BE data integrity is related to FDA electronic systems Q&A· Compare FDA BA/BE data integrity and FDA electronic systems Q&A Unverified link
- MHRA GxP data integrity is related to Annex 11 (2011)· Compare MHRA GxP data integrity and Annex 11 (2011) Unverified link
- MHRA GxP data integrity is related to Annex 15· Compare MHRA GxP data integrity and Annex 15 Unverified link
- ICH Q9(R1) is the risk basis for MHRA GxP data integrity· Compare ICH Q9(R1) and MHRA GxP data integrity Unverified link
- EMA notice: CS in trials complements EMA CS clinical trials· Compare EMA notice: CS in trials and EMA CS clinical trials Unverified link
- EMA notice: CS in trials is related to ICH E6(R3) GCP· Compare EMA notice: CS in trials and ICH E6(R3) GCP Unverified link
- PIC/S PI 011-3 interprets PIC/S GMP Guide PE 009· Compare PIC/S PI 011-3 and PIC/S GMP Guide PE 009 Unverified link
- PIC/S PI 006-4 interprets PIC/S GMP Guide PE 009· Compare PIC/S PI 006-4 and PIC/S GMP Guide PE 009 Unverified link
- PIC/S PI 006-4 is related to Annex 15· Compare PIC/S PI 006-4 and Annex 15 Unverified link
- FDA CSA guidance complements FDA software validation· Compare FDA CSA guidance and FDA software validation Unverified link
- FDA CSA guidance is related to Part 11 scope guidance· Compare FDA CSA guidance and Part 11 scope guidance Unverified link
- FDA CSA guidance is related to ISPE GAMP 5, 2nd ed.· Compare FDA CSA guidance and ISPE GAMP 5, 2nd ed. Unverified link
- Part 11 scope guidance is related to FDA software validation· Compare Part 11 scope guidance and FDA software validation Unverified link
- FDA blood system validation is related to FDA software validation· Compare FDA blood system validation and FDA software validation Unverified link