EudraLex Volume 4, Chapter 4: Documentation

What the authority record establishes

Chapter 4 places specifications, instructions, procedures, records, reports, controls, approval, availability, legibility, traceability, correction, retention, and hybrid-system relationships within the pharmaceutical quality system.

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

Laboratory architecture should show which system owns each instruction, specification, raw record, result, review, approval, exception, and retained copy across electronic and paper processes.

Affected operating stages

• Document Creation
• Approval
• Issue
• Execution
• Recording
• Correction
• Retention

Capabilities to examine

Method Test Specification And Acceptance-Limit Management

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 method test specification and acceptance-limit management.

Guided Laboratory Procedure And Worksheet Execution

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 guided laboratory procedure and worksheet execution.

Result Capture Calculation Review And Approval

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 result capture calculation review and approval.

Out-Of-Specification Deviation And Exception Workflow

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 out-of-specification deviation and exception workflow.

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.

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

• quality units
• laboratory operations
• records management
• technology
• 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

A repository or electronic signature feature does not establish compliant documentation practice or the suitability of a record design.