⚠️ Important Disclaimer
Velocity LIMS provides a foundation for regulatory compliance but does not guarantee compliance. Each laboratory must work with qualified regulatory consultants to ensure full compliance with applicable regulations. This guide outlines capabilities and requirements but should not be considered legal or regulatory advice.
Major Regulatory Bodies for Clinical Laboratories
Clinical laboratories must comply with various regulatory frameworks depending on their location, scope, and accreditation goals. Velocity LIMS is designed to support compliance workflows across multiple regulatory environments.
- FDA (Food and Drug Administration) - Medical device regulations, 21 CFR Part 820 (Quality System Regulation), 21 CFR Part 11 (Electronic Records)
- CLIA (Clinical Laboratory Improvement Amendments) - Quality standards for laboratory testing, personnel requirements, quality control
- CAP (College of American Pathologists) - Laboratory accreditation program, proficiency testing, quality assurance standards
Velocity LIMS Compliance Capabilities
The following sections detail what Velocity LIMS provides out-of-the-box versus what requires additional configuration or external systems.
✅ Included in Velocity LIMS
- Role-Based Access Control (RBAC) - Granular permissions system with audit trails
- Sample Chain of Custody - Complete tracking from collection to disposal
- Audit Trail System - All data changes logged with user, timestamp, and reason
- Electronic Signatures - Multi-level approval workflows with digital signatures
- Data Integrity Controls - Database-level data protection and validation
- User Authentication - Secure session-based login with permission validation
- Specimen Management - Collection, processing, storage, and disposal tracking
- Quality Control Tracking - QC sample processing and result monitoring
- Workflow Automation - Configurable laboratory processes and routing
- Inventory Management - Reagent, consumable, and equipment tracking
- Equipment Integration - API framework for instrument connectivity
- Custom Fields & Forms - Flexible data collection for regulatory requirements
Ready to Start Your Compliance Journey?
Get started with Velocity LIMS and build a foundation for regulatory compliance in your clinical laboratory.