Quality System
Always Audit-Ready
We’re on a mission to provide best-in-class GLP bioanalytical and GMP analytical services.
Commitment to Quality starts at the Top
We are dedicated to the continuous improvement of our Quality Management System. Ongoing activities to ensure that we remain current in our approach to quality include
- Comprehensive training program
- Responsive to deviations and non-conformities
- Scheduled routine internal audits
- Implementation of corrective actions
- Rigorous sample management program
- Validated computer systems and qualified equipment
Quality Agreements and Statements of Work that explicitly define responsibilities and deliverables
QA Oversight of Critical Records including
- Protocols
- Laboratory records
- Reports
Systems to ensure data integrity
- Traceability
- Security
- Archiving
cGMP and GLP Compliance
- Fully compliant with FDA Current Good Manufacturing Practice (cGMP) Regulations 21 CFR Parts 210 and 211
- Fully compliant with FDA Good Laboratory Practice (GLP) Regulations 21 CFR Part 58 and OECD Principles of Good Laboratory Practice