Shifting the Compliance Paradigm


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Product Description

View on Regulatory Compliance

Michael Kuehne is President of ACSYS Inc., Hillsborough, N.J., which specializes in developing quality and compliance solutions that combine R&D and manufacturing capabilities to deliver sustained improvement in R&D, Quality, Operations, Clinical, and Regulatory Affairs departments. This enhanced capability supports organizational capabilities to develop and launch new products and processes.
Developing an innovative methodology for regulatory compliance can provide companies with a strategic advantage in the design and development of new products and robust manufacturing processes by avoiding suboptimal results that typically do not meet requirements set forth in the FDA guidelines.
Many organizations perceive regulatory compliance as an unavoidable obligation in a federally regulated industry. Generally, compliance is a critical element on the list of “must-do items” to be completed before launching a new product. But rarely is compliance recognized as a strategic advantage — an enabler to designing and developing new products and robust manufacturing processes…

Sidebar: A Validation Case Study

Expert on this Topic
Michael Kuehne
, President, ACSYS Inc.