LIMS Validation Services
Comprehensive validation services to ensure your LIMS meets regulatory requirements and performs reliably. From IQ through PQ, we deliver complete validation documentation.
Complete Validation Lifecycle
IQ - Installation Qualification
Documented verification that your LIMS is correctly installed according to specifications.
OQ - Operational Qualification
Verification that LIMS functions correctly across all operational parameters and user scenarios.
PQ - Performance Qualification
Confirmation that LIMS performs consistently under real-world laboratory conditions.
Regulatory Framework Compliance
FDA 21 CFR Part 11
Electronic records and signatures
CLIA
Clinical laboratory requirements
CAP
Accreditation standards
ISO 15189
Medical laboratory quality
GAMP 5
Pharmaceutical guidance
EU Annex 11
Computerized systems
Validation Deliverables
Validation Master Plan
Comprehensive strategy document defining scope, approach, and responsibilities
User Requirements Specification
Detailed functional and regulatory requirements documentation
Validation Protocols
Step-by-step IQ, OQ, PQ test protocols with acceptance criteria
Traceability Matrix
Requirements to test case mapping for complete coverage
Test Scripts
Detailed test cases with expected results and evidence capture
Validation Summary Report
Final report documenting validation completion and findings
SOPs
Standard operating procedures for ongoing validated state maintenance
Change Control Procedures
Processes for managing changes while maintaining validation