Quality Systems and Standards Implementation

The absence of a single Quality System model gets many companies into difficulty with regulatory agencies again and again. As healthcare industry veterans, it is something we have seen often.

So we have decided to address the problem head on.

Galenisys has developed a new, robust Quality System model, incorporating Standards and model Standard Operating Procedures. Our new model not only meets the requirements of all major regulatory agencies, but provides the foundation for transforming Quality and Compliance from a regulatory issue into a competitive advantage for your company

Rooted in FDA, EMA and ICH guidelines, our Quality System is fully conceived by element and sub element. It is supported by Quality and Engineering Standards as well as model SOPs and is also the foundation from which we have developed our Training System.

If you choose to adopt it, the Galenisys Quality System model will provide you with complete peace of mind wherever you operate and whichever market you are manufacturing for.