Laboratory Records
The section specifies content for laboratory records, including samples, methods, test data, calculations, results, initials, dates, second-person review, and investigation references.
What the authority record establishes
The section specifies content for laboratory records, including samples, methods, test data, calculations, results, initials, dates, second-person review, and investigation references.
Binding for operations within the regulation's 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
It anchors a buyer's record model for sample identity, method control, raw data, calculation, result review, and traceable exceptions in relevant drug-manufacturing laboratories.
Affected operating stages
- Sample Receipt
- Method Execution
- Data Capture
- Calculation
- Review
- Release Support
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.
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.
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.
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.
Affected buyer audiences
- quality-control laboratories
- quality units
- manufacturing quality
- 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 section does not prescribe a LIMS, ELN, CDS, SDMS, or LES architecture and does not establish that a configured system satisfies its requirements.