EudraLex Volume 4, Annex 11: Computerised Systems
Annex 11 addresses risk management, personnel, suppliers, validation, data, accuracy checks, storage, printouts, audit trails, change, security, incident management, signatures, business continuity, and archiving.
What the authority record establishes
Annex 11 addresses risk management, personnel, suppliers, validation, data, accuracy checks, storage, printouts, audit trails, change, security, incident management, signatures, business continuity, and archiving.
Applicable within the EU GMP framework according to current law and guidance
The exact official title, issuing body, jurisdiction, version or application record, and linked source define the scope of this page. Readers should not transfer the authority's status to a commercial product or infer transaction-, patient-, system-, site-, or organization-specific applicability from this summary.
Why it matters to this market
It keeps laboratory-system assurance connected to the full system lifecycle and regulated process, not merely a list of application functions.
Affected operating stages
- Risk Management
- Supplier Assessment
- Validation
- Operation
- Change
- Continuity
- Archive
Capabilities to examine
Instrument Integration And Bidirectional Worklists
Ask how the system or service identifies the controlling source and version, applies customer-specific interpretation, handles exceptions, preserves human judgment, and retains evidence for instrument integration and bidirectional worklists.
Raw Scientific-File Capture And SDMS Archive
Ask how the system or service identifies the controlling source and version, applies customer-specific interpretation, handles exceptions, preserves human judgment, and retains evidence for raw scientific-file capture and SDMS archive.
Chromatography Acquisition Processing And Reporting
Ask how the system or service identifies the controlling source and version, applies customer-specific interpretation, handles exceptions, preserves human judgment, and retains evidence for chromatography acquisition processing and reporting.
Electronic Signatures Audit Trails And Record History
Ask how the system or service identifies the controlling source and version, applies customer-specific interpretation, handles exceptions, preserves human judgment, and retains evidence for electronic signatures audit trails and record history.
Role Identity Access And Segregation-Of-Duties Controls
Ask how the system or service identifies the controlling source and version, applies customer-specific interpretation, handles exceptions, preserves human judgment, and retains evidence for role identity access and segregation-of-duties controls.
API Integration And Enterprise Interoperability
Ask how the system or service identifies the controlling source and version, applies customer-specific interpretation, handles exceptions, preserves human judgment, and retains evidence for API integration and enterprise interoperability.
Deployment Administration Change Control And Validation Support
Ask how the system or service identifies the controlling source and version, applies customer-specific interpretation, handles exceptions, preserves human judgment, and retains evidence for deployment administration change control and validation support.
Affected buyer audiences
- EU GMP laboratories
- quality units
- system owners
- validation teams
- auditors
Implementation questions
- Which entities, products, populations, transactions, systems, sites, or jurisdictions are actually within scope?
- What is binding, what is guidance, and what is a technical or consensus standard?
- Which publication, adoption, effective, application, transition, and enforcement dates differ?
- Who owns legal, clinical, quality, regulatory, policy, or operational interpretation?
- How will a source revision affect open work and historical decisions?
Interpretation boundary
Annex 11 does not certify a supplier or product and does not establish validation or GMP fitness for a configured system.