Xybion Corporation I 105 College Rd East I Princeton, NJ 08540 I 609 -512-5790 I sales@xybion.com I www.xybion.com Industry Best Practice White Paper Quality, Compliance & Validation Challenges in Maintaining the Validated State for Emerging Technologies Introduction The FDA regulated pharmaceutical, medical device, and consumer products industries (hereafter referred to collectively as the “pharmaceutical industries ”) have incorporated computerized technologies into almost every aspect of their research, development, and manufacturing activities. Perhaps more than any other field of scientific or technological endeavor, computerized systems have evolved at a pace unequalled in history. Indeed, reasonable arguments can be made that the evolution of computerized syste

Join for free to read