Qualification of facilities, utilities & equipment
In your Life Science facilities, all of the above mentioned tasks are subject to strict qualification processes involving Design Qualification (DQ), Commissioning, Installation Qualification (IQ), Operational Qualification (OQ), Performance Qualification (PQ) and Requalification (RQ) to ensure they are all well-suited for GMP use.
Our team of engineers, pharmacists and validation and QA specialists is experienced in defining User Requirement Specifications, setting up design qualifications and reviews, conducting Factory & Site Acceptance Tests, and performing Installation / Operation & Performance Qualifications. They work their way through the V-Model and adopt a risk-based approach.
Furthermore, our team of validation engineers conducts hands-on validation measurements for:
- Sterilisation Processes
- Temperature distribution
- Medical gas quality
- Cleanroom, class A-D (According to NEN-ISO 14644 and VCCN Guideline 7(the Dutch guideline for operating rooms)
- Air flow
- Filter integrity
- Particle count
- Microbial testing