Quality & Compliance
Defensible data built on validated methods, calibrated instruments, and rigorous documentation standards.
Quality Management System
Our quality management system ensures reliable, traceable, and defensible analytical results. Every step — from sample receipt to final report — is documented, reviewed, and validated against defined acceptance criteria.
Standard Operating Procedures govern all laboratory activities. Instruments are calibrated with NIST-traceable reference standards. All data undergoes second-person review before release.
Regulatory Frameworks
21 CFR Part 58 — GLP
Studies conducted in accordance with Good Laboratory Practice principles for non-clinical laboratory studies. Facility, equipment, personnel, and study documentation maintained per GLP standards.
cGMP Compliance
Testing for pharmaceutical products performed under current Good Manufacturing Practice regulations. Documentation practices follow ALCOA+ data integrity principles.
21 CFR Part 11
Electronic records and signatures aligned with FDA requirements. Audit trails, access controls, and system validation ensure data integrity throughout the analytical lifecycle.
ISO 17025 Aligned
General requirements for the competence of testing and calibration laboratories. Method validation, measurement uncertainty, and proficiency testing programs maintained.
Key Quality Practices
Instrument Calibration
All instruments calibrated with NIST-traceable standards on documented schedules. System suitability tests run before every analytical sequence. Calibration records maintained and available for client audit.
Method Validation
Methods validated for specificity, linearity, accuracy, precision, range, LOD/LOQ, and robustness per ICH Q2(R2) and CIPAC guidelines. Validation reports available on request.
Data Review & Integrity
All raw data reviewed by a second qualified scientist. Electronic audit trails maintained. Final reports include method references, acceptance criteria, and conclusions with supporting chromatograms.
Documentation Standards
Questions About Our Quality Program?
Ask about audits, documentation, or regulatory compliance support.