Advisory Document of the Working Party on Good Laboratory Practice on GLP Data Integrity

What the authority record establishes

The advisory document addresses data governance, lifecycle, criticality, metadata, computerized systems, dynamic data, cloud and service arrangements, review, archive, and reconstruction in GLP settings.

Implemented through national GLP programs and applicable requirements

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 supports deeper evaluation of whether a laboratory architecture retains enough context and metadata to reconstruct activity across instruments, analytical systems, scientific repositories, and study records.

Affected operating stages

• Governance
• Data Generation
• Processing
• Review
• Transfer
• Reporting
• 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.

ELN Experiment Authoring And Collaboration

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 ELN experiment authoring and collaboration.

Scientific Data Models Ontology And Semantic Context

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 scientific data models ontology and semantic context.

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

• GLP facilities
• study directors
• quality assurance
• system owners
• sponsors

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 advisory document does not establish the integrity of particular data or the suitability, validation, or scientific validity of a system or study.