Data Integrity and Compliance With Drug CGMP: Questions and Answers
The guidance addresses complete, consistent, accurate data; metadata; audit trails; access; review; blank forms; testing into compliance; and investigation of data-integrity problems.
What the authority record establishes
The guidance addresses complete, consistent, accurate data; metadata; audit trails; access; review; blank forms; testing into compliance; and investigation of data-integrity problems.
Non-binding guidance describing FDA's current thinking
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 systems must preserve record context, metadata, changes, roles, review, and investigation across instruments, CDS, SDMS, LIMS, LES, and manual steps rather than treating an audit-trail feature as the complete control system.
Affected operating stages
- Data Creation
- Processing
- Review
- Change
- Retention
- Investigation
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.
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.
Affected buyer audiences
- laboratory management
- quality units
- system owners
- data reviewers
- 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
The guidance does not make a data-integrity finding for a particular record, configuration, person, process, or product.