From a long history in regulated environments, PEMAC have extensive experience in validation. We provide a full validation service and/or confirmation of protocols with our solution. We have a full appreciation of the critical importance of controlling the installation and upgrading of software applications.
Pharmaceutical and Medical Device
We have amassed substantial experience specific to this sector. Our products meet 21 CFR Part 11 standards to help ensure regulatory requirements are met.
Additionally, we can also provide customers assistance with:
Our Validation Service includes:
Installation Qualification (IQ)
Operational Qualification (OQ)
Performance Qualification (PQ)