Validation & Qualification
Qualification provides documented evidence that a facility, system or process does what it was designed to do. We support Design Qualification (DQ), Installation Qualification (IQ), Operational Qualification (OQ) and Performance Qualification (PQ), together with commissioning and qualification planning, cleaning validation and computerised system validation, in line with Good Manufacturing Practice (GMP) Annex 15 and the expectations of the Pharmaceutical Inspection Co-operation Scheme (PIC/S). Documentation is developed alongside design, construction and commissioning, ensuring that compliance evidence is built progressively into the project rather than assembled retrospectively before inspection.
Key capabilities and applications
Typical applications
- Commissioning and Qualification (C&Q) programmes
- Equipment qualification
- Cleaning and process validation
Representative solutions
- Validation master planning
- Protocol development and execution
- Turnover documentation
Where this capability creates value
- Pharmaceuticals
- Biotechnology
- Medical devices
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