Whitepaper- Balancing cGMP vs. SOX Compliance Guidelines

Abstract: As government agencies increase scope of regulations, companies acquire diverging technologies, and IT responsibilities increase the need for balancing specific regulatory demands will also increase. In some cases regulatory demands may appear to be in conflict and cause resource planning issues within the IT  department. FDA regulatory guidances verses Sarbanes-Oxley compliance demands can certainly be viewed as one such example. With good planning the two guidances can be balanced to complement each other. Thus reducing the strain on IT resources and facilitate common development, issue management, and validation efforts. This paper will explore an approach to resolving differences, balancing the two guidances, and focusing IT compliance efforts into one compliance effort.

About the Author: Douglas L. Lively works as a Project Manger for Invensys Operations Management and is based in Cary. North Carolina. He is a Certified Quality Auditor through the American Society for Quality (ASQ) and his Project Management Certification is through Project Management Institute (PMI). Mr. Lively has more than 10 years experience in regulatory software compliance and has managed regulatory projects ranging from medical devices to LIMS and ERP systems.