Good Laboratory Practice for Nonclinical Laboratory Studies

What the authority record establishes

Part 58 establishes organizational, personnel, facility, equipment, protocol, operating-procedure, record, reporting, and archive requirements for specified nonclinical studies.

Binding for studies within scope

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

Research-system evaluations should trace study, specimen, protocol, instrument, observation, amendment, report, and archive records without assuming an ELN or LIMS alone constitutes a GLP system.

Affected operating stages

• Study Planning
• Procedure Control
• Execution
• Observation
• Reporting
• Archive

Capabilities to examine

Sample Registration Identity And Lifecycle 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 sample registration identity and lifecycle management.

Aliquot Batch Container And Chain-Of-Custody 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 aliquot batch container and chain-of-custody management.

Instrument Asset Calibration And Maintenance Records

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 asset calibration and maintenance records.

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.

Protocol Method Template And Version 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 protocol method template and version management.

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

• nonclinical research
• study directors
• quality assurance units
• toxicology laboratories
• technology owners

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 regulation applies to defined studies and does not certify software, validate a workflow, or establish scientific validity.