Quality & Compliance
Built-in quality management tools for GLP, ISO accreditation, and regulatory compliance. Comprehensive audit trails, document control, training records, and QC management to maintain the highest standards.
Quality Control Management
Comprehensive QC tools to monitor analytical performance and ensure reliable results. Automatic rule evaluation with Westgard multi-rules and Levey-Jennings charting.
- Westgard Rules - Configurable Westgard multi-rule evaluation. Automatic QC failure detection and lockout of non-compliant instruments.
- Levey-Jennings Charts - Interactive Levey-Jennings charts with trend analysis. Visual identification of systematic shifts and random errors.
- EQA/PT Integration - Manage external quality assessment participation. Track EQA submissions and monitor performance against peers.
- IQC Scheduling - Automated IQC scheduling based on test volume and time intervals. Reminder alerts for upcoming QC runs.
Complete Audit Trail
Every action in the system is recorded with full traceability. Demonstrate compliance with regulatory requirements and support internal quality investigations.
- Comprehensive Logging - Automatic capture of all user actions, system events, and data changes. Tamper-proof audit log with cryptographic verification.
- Change Tracking - Full before/after values for all data modifications. Track who changed what and when with complete context.
- Reason Codes - Mandatory reason codes for result amendments and critical changes. Configurable approval workflows for sensitive modifications.
- Audit Reporting - Flexible audit reports for regulatory inspections and internal review. Filter by date, user, action type, or affected records.
Document Control
Centralised document management for SOPs, work instructions, and policies. Version control, approval workflows, and controlled document distribution with training acknowledgment tracking.
- Version Management - Full version history with controlled document lifecycle. Archive previous versions while maintaining accessibility for audit.
- Approval Workflows - Configurable review and approval processes. Electronic signatures with 21 CFR Part 11 compliance.
- Controlled Distribution - Ensure staff access current document versions. Read receipt tracking and acknowledgment workflows.
- SOP Management - Link SOPs directly to workflows and procedures. Context-sensitive access to relevant documents during testing.
Regulatory Compliance Support
CoreLIMS is designed to support compliance with key regulatory standards and accreditation requirements.
ISO 15189
Full support for medical laboratory accreditation requirements including quality management and technical competence.
UKAS Accreditation
Tools and documentation to support UKAS assessment preparation and ongoing compliance maintenance.
GDPR Compliance
Data protection controls including consent management, data minimisation, and subject access request handling.
Good Laboratory Practice
Support for GLP requirements in research laboratory settings with appropriate audit trails and documentation.
21 CFR Part 11
Electronic records and electronic signatures compliance for laboratories operating under FDA regulations.
CAP Requirements
Support for College of American Pathologists accreditation standards and checklist requirements.
Quality & Compliance Capabilities
Comprehensive tools for quality management and regulatory compliance.
Non-Conformance Management
Track and manage non-conformances with CAPA workflows. Root cause analysis and effectiveness verification.
KPI Dashboards
Real-time quality indicators and performance metrics. Monitor TAT, rejection rates, and QC performance.
Internal Audit Support
Schedule and track internal audits. Manage findings, corrective actions, and closure verification.
Training Records
Maintain staff training records and competency assessments. Link authorisations to demonstrated competence.
Equipment Management
Track equipment maintenance, calibration, and qualification. Automated scheduling and compliance alerts.
Reagent Management
Lot tracking, expiry monitoring, and reagent qualification. Link results to specific reagent lots.
Incident Management
Capture and investigate quality incidents. Trend analysis to identify systemic issues.
Validation Support
Method validation and verification documentation. Templates and workflows for validation studies.
Record Retention
Configurable retention policies meeting regulatory requirements. Automated archival and disposal workflows.
Achieve and Maintain Accreditation
See how CoreLIMS quality management tools can support your laboratory's compliance and accreditation goals.