LIMS & QMS Integration
Laboratory Information Management System meets Quality Management System
LIMS Software
Laboratory Information Management System – the central hub for all laboratory operations, sample tracking, testing, and data management.
- Sample tracking and chain of custody
- Test scheduling and execution
- Instrument integration and data capture
- Results management and reporting
- Inventory and reagent tracking
- Laboratory workflow automation
- Out-of-specification (OOS) investigations
- Stability study management
- Certificate of Analysis (CoA) generation
- Electronic lab notebooks (ELN)
QMS System
Quality Management System – ensures compliance, manages documentation, tracks quality events, and maintains regulatory standards.
- Document control and versioning
- Change control management
- CAPA (Corrective/Preventive Actions)
- Deviation management
- Complaint handling
- Audit management (internal/external)
- Training and competency tracking
- Supplier quality management
- Risk management
- Validation and qualification records
Critical Integration Points
Test Results
LIMS test results automatically flow to QMS for batch review and release decisions
OOS Handling
Out-of-specification results trigger automatic deviation creation in QMS
Document Sync
Test methods, SOPs, and specifications synchronized between both systems
Change Control
QMS change controls update LIMS test methods and specifications
Training Records
QMS training status controls LIMS user access and test authorization
Audit Trail
Combined audit trails for complete traceability across systems
Data Flow Architecture
🧪 LIMS
Sample Analysis
🔗 Middleware
API/Integration Layer
✅ QMS
Quality Decision
📦 ERP
Batch Release
Real-time bidirectional data exchange via REST APIs, message queues, or database integration
Integration Benefits
Faster Processing
Automated data transfer eliminates manual entry, reducing batch release time by 50-70%
Data Integrity
Single source of truth with automatic synchronization prevents data discrepancies
Complete Traceability
End-to-end visibility from sample receipt to quality decision and release
Reduced Errors
Elimination of manual transcription reduces human errors by 90%+
Regulatory Compliance
Integrated audit trails meet FDA 21 CFR Part 11 and EU GMP requirements
Cost Savings
Reduced labor, fewer deviations, and faster time-to-market deliver significant ROI
Integrated Workflow Example
Sample Login
Sample registered in LIMS with batch info from ERP/QMS
Testing
Tests executed per approved methods, instruments auto-feed data
Results Review
Lab analyst reviews results in LIMS, approves or investigates
Auto Transfer
Approved results automatically sent to QMS batch record
QA Review
QMS consolidates all data for quality decision
Batch Release
QP certifies and releases batch to ERP for distribution