From a long history in regulated environments PEMAC have extensive experience in validation and provide a full validation service and/or confirmation protocols with our products. We have a full appreciation of the critical importance of controlling the installation and upgrading of software applications.
We have amassed substantial experience specific to this sector. Our products meet 21 CFR Part 11 standards to help ensure regulatory requirements are met.
Food and Beverage sector
Internal validation processes are of vital importance between vendors and their suppliers. For our clients in this situation, we endeavour to provide them with the necessary processes to ensure their internal or sector specific regulatory requirements are met.
Additionally, we can also provide customers assistance with:
- Sample user requirement specification.
- Validation master plans.
- Design of user specific protocols.
Our Validation Service includes:
- Installation Qualification (IQ).
- Operational Qualification (OQ.).
- Performance Qualification (PQ).
Contact us on +353 (0)1 466 3888
MANAGING YOUR WORKPLACE. PROTECTING YOUR WORLD.