Commissioning, Qualification and Validation (CQV)
Our comprehensive Commissioning, Qualification and Validation (CQV) services are designed to ensure that your facilities, utilities and equipment meet all regulatory requirements, are fit for purpose and operate within designated parameters. From the initial design and validation master plan up to performance qualification, we provide end-to-end support to guarantee compliance and operational excellence.
Our portfolio of CQV services includes:
- Validation master plans
- Author qualification protocols (IQ, OQ and PQ)
- User Requirements Specifications (URS)
- Functional Specifications (FS)
- Detailed Design Specifications
- Design Qualification
- Cleaning validation (CIP)
- Sterilisation validation (SIP)
- Validation of utilities (such as HVAC, compressed air and water systems)
Trusted by top-tier teams worldwide
Featured case studies
Medical device CSV
Medical device CSV Introduction IVD manufacturer The client is an IVD manufacturer based in Europe. Although already ISO 13485:2016 certified, they were agnostic when it came to GAMP 5 and 21 CFR PART 11. They have 80 employees based over 2 sites in France. Apotech consultant: Apotech’s consultant coordinated 5 technicians, acting as project manager…
Tech Transfer
Tech Transfer (COVID-19 Vaccine) Introduction Worldwide Vaccine Manufacturer British-Swedish multinational pharmaceutical and biotechnology company. Areas Oncology, cardiovascular, gastrointestinal, infection, neuroscience, respiratory, and inflammation. Apotech Consultants The Apotech Consultants were embedded in the client’s global TechOps team. This team consisted of ~50 people, spread across the globe, and our consultants reported to the Director of Global…
Process and Test Method Validation Review and Improvement
Process and Test Method Validation Review and Improvement Introduction Cardiac Devices Our client is a leading manufacturer of Class III minimally invasive cardiac devices, based in Germany and selling to 85 countries worldwide. Apotech consultants Our consultants implemented a risk-based approach to improve quality and compliance, and implement practical solutions for the organisation. Standards &…