Quality management system
An integrated ISO/IEC 17025 and ISO 9001 QMS owned by a dedicated Quality Assurance department independent of operations.
Quality assurance & compliance
Defensible data, by design.
Quality is not a department that signs off at the end of a project. It is the operating system underneath every assay we run, every chromatogram we integrate, and every report we release.
21 CFR Part 11 data integrity
ALCOA+ principles enforced through validated LIMS, audit-trail-enabled CDS software (Empower, Chromeleon, Analyst), and role-based access controls.
Method validation
Methods validated per ICH Q2(R2) and USP <1225>: specificity, linearity, accuracy, precision, LOD/LOQ, range, and robustness.
Chain of custody
Every sample is barcoded at receipt and tracked through preparation, analysis, review, and storage with immutable handoff records.
Document & training control
Controlled SOPs, analyst qualification matrices, and competency assessments managed through MasterControl QMS.
Environmental monitoring
Continuously monitored sample storage (-80°C, -20°C, 2–8°C, 25°C/60%RH, 40°C/75%RH) with 24/7 alarm escalation.
Proficiency testing
External validation, every year.
Active participation in inter-laboratory proficiency programs is a cornerstone of our accreditation. Results are reviewed by the QA Director and corrective actions tracked to closure.
A2LA Proficiency TestingChemistry & microbiology programs, annual
AOAC LPTPFood, supplement, and cannabis matrices
USP Pharmaceutical Analysis PTDissolution, assay, related substances
NSI / ERA EnvironmentalTrace elemental and organic
LGC Standards AQAPharmacopeial method verification
Quality documentation requests
SOP summaries, validation reports, and supplier questionnaires available on request.