Quality Assurance & Compliance

To ensure quality of services and integrity of data, we have a well-documented and audited Quality Control System (QCS) in place.  Version controlled, written instructions exist to achieve uniformity in our analytical operations and a corresponding set of procedural and administrative controls are in place to govern our computer systems.

  • Standard Operating Procedures (SOPs) and Departmental Instructions (DIs) provide guidance
  • Title 21 CFR Part 11 compliant with FDA guidelines on electronic records and signatures
  • Validation in the form of peer review is performed on all work products
  • Experienced at integrating with client-specific policies and procedures
  • Successfully completed client audits utilizing both internal and external compliance teams
  • EU-US and Swiss-US Privacy Shield Principles (view PDF)
  • BSSI does not use subcontractors for its statistical services