Apex Technical Resources understands that "if it isn't documented, then it's only a rumor". Properly documenting the work that has been done and challenging the performance of production systems appropriately is key to making new production systems hold up to the scrutiny of both in-house and government regulatory audits. ATR is interested in learning what your company validation requirements are and working to become a qualified validation service provider for you. We are not afraid of paperwork!
ATR founder Larry Ziniel has a great deal of experience working in an FDA regulated environment. He is certified to work on low acid food systems as a result of meeting the rigorous requirements of the FDA's Better Process Control School. A veteran of designing and installing systems for clean rooms and other GMP areas, Larry understands the importance of working with quality engineers and validation professionals throughout the life of a project. He has written and executed a variety of validation packages in the food and pharmaceutical industries that are compliant with 21CFR11, 21CFR107 and 21CFR113 regulations.
