Providing the Evidence of Data Integrity and Reliability
Every analytical result supporting product release, stability, or registration must be produced by a validated method using qualified equipment. Method Validation (MV) and Equipment Qualification (EQ) are mandatory under cGMP and ensure data integrity, reliability, and traceability.
BQCIS executes all validations per ICH Q2 (R1) and equipment qualifications per the GAMP 5 V-Model. We deliver complete lifecycle documentation — from protocol generation and testing to final summary reporting — ready for inspection and submission.
Our programs demonstrate to regulators that your methods and instruments perform as intended, reducing audit risk and accelerating product approval.
Key Validation & Qualification Services
Key Benefits of Validation & Qualification
Regulatory Compliance & Audit Readiness
Meets FDA, EMA, and WHO data-integrity expectations for validated analytical methods and qualified systems.
Improved Analytical Reliability
Demonstrates that laboratory methods and equipment perform consistently, reducing data deviations and retests.
Operational Efficiency & Traceability
Standardized protocols and documentation enhance workflow efficiency and maintain full audit trails.
Confidence in Data Integrity
Ensures every data point is accurate, attributable, and defensible — fostering regulator and client confidence.
Success Story
Successful OQ/PQ for High-Throughput HPLC Systems
A contract testing lab needed rapid, documented qualification for newly acquired HPLC units before cGMP use.
BQCIS executed complete OQ/PQ protocols, verifying flow-rate accuracy, injector precision, and wavelength calibration per URS and vendor specs.
All units qualified ahead of schedule with fully traceable documentation, enabling immediate audit readiness and expanded testing capacity.