Commissioning, Qualification & Validation of production equipment
Our Expertise in CQV
At Normec, we ensure that your production equipment is fully validated and compliant, so you can operate with complete peace of mind. With our expertise in CQV (Commissioning, Qualification, Validation), we guarantee that your systems meet the highest regulatory standards and consistently perform at their best within the life sciences industry.
Our expertise includes:
Formulation equipment: compounding vessels, mixing equipment, filtration systems
CIP/SIP Skids: Cleaning-in-Place / Sterilisation-in-Place
(Sterile) isolators & RABS processes
Preparation equipment: parts washers, autoclaves, filter integrity testers, stopper processors
(Sterile) filling machines
Inspection machines
Our Flexible CQV Support
At Normec Advipro, we provide comprehensive support in the CQV (Commissioning, Qualification, Validation) of production equipment, tailored to the specific needs of your organization. Whether you require full project support, consultancy to bring in GxPertise, or training and on-site testing, we have the right solution for your situation.
Our approach includes:
Commissioning: We guide you through the entire commissioning phase, from the Factory Acceptance Test (FAT) to the Site Acceptance Test (SAT) and the final qualification, ensuring your systems meet all predefined requirements.
Qualification & Validation: We deliver thorough qualification and validation services, from drafting the User Requirements Specification (URS) to commercial startup. We ensure compliance with the strictest GxP standards and international guidelines, providing not just compliance, but also operational reliability and efficiency.
Ces services peuvent également vous intéresser
CQV (Commissioning, Qualification, Validation) of Laboratory Equipment
Mobile Validation Experts (MoVE)
Entreprises leaders dans ce service
Normec Advipro
Lille Belgium