Validation Services
LIMS validation that survives your next audit.
Comprehensive validation services to ensure your LIMS meets regulatory requirements and performs reliably. From IQ through PQ, we deliver complete validation documentation.
Whether you're implementing a new system or revalidating an existing one, we handle the entire lifecycle so your team can focus on running the lab.
Complete Lifecycle
IQ, OQ, PQ — done right
Each qualification phase is executed with rigorous documentation and clear acceptance criteria, designed to meet the most demanding regulatory standards.
Documented verification that your LIMS is correctly installed according to specifications.
Verification that LIMS functions correctly across all operational parameters and user scenarios.
Confirmation that LIMS performs consistently under real-world laboratory conditions.
Regulatory Compliance
Built for every framework that matters
Our validation protocols are designed to satisfy multiple regulatory frameworks simultaneously, reducing effort and eliminating gaps.
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
What You Receive
Validation deliverables that hold up
Every engagement produces audit-ready documentation designed to satisfy inspectors and protect your lab.
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
Related Services
Explore more ways we can help
Clinical Lab Validation Resources
Clinical labs have specific validation requirements for CLIA and CAP compliance. Learn more about implementing validated systems in clinical environments.
LIMS for Clinical Labs: Implementation & Validation Guide