Quality Systems 2017-08-09T18:52:33+00:00

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

Commitment To Quality
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

We welcome sponsor audits. Call for specific SOPs and full Quality Manual

Quality Manual
Index of SOPs

Questions?

Contact Us