Part 11 and Drug Development: A Q&A Reference Guide (March, 2004) -
Part 11 requirements have now taken their place alongside longstanding regulations such as GCP and GLP as standards critical to those developing new drugs. As computer technology, the Internet, email, and other technological advances have worked their way into virtually every aspect of new drug development, so too have emerging and rapidly evolving Part 11 standards. Although the FDA's "new" Part 11 approach unveiled in late 2003 was seen as good news by industry, it has also spawned a new generation of difficult questions for every person involved in the drug development process. From clinical research associates (CRA) and clinical site staff dealing with EDC-based systems and electronic patient diaries to clinical data managers coping with complex clinical data management systems to regulatory affairs staff making electronic submissions, Part 11 standards are very much an element of everyday life. Developed by industry experts, The "new" Part 11 and Drug Development: A Q&A Reference Guide addresses the most common and difficult questions regarding the day-to-day interpretation and implementation of the all-new Part 11 standard today. What specific clinical records and systems must be Part 11 compliant? What are Part 11 standards for email systems used to communicate study-related data, information, and queries from sponsor/CROs to clinical trial sites? And how, specifically, is Part 11 relevant to clinical trial monitors, study sites, IRBs, data managers, trial auditors and others? From electronic signatures to electronic record retention and from clinical system validation to creating audit trails, this new reference guide provides authoritative answers to the Part 11-related questions confronting development professionals today. As the ultimate Part 11 resource guide for pharma R&D staff, The "new" Part 11 and Drug Development: A Q&A Reference Guide provides, in one pocket-sized handbook: * Detailed commentary from leading Part 11 experts on 150+ questions across 14 areas critical to the drug development process. * The latest insights and commentary from FDA officials on critical Part 11 issues. * The Part 11 regulations, the FDA's August 2003 Part 11 Scope and Application Guidance, and other important guidance documents. About the Authors John McKenney, Lisa Olson, and Keith Benze are with SEC Associates, Inc., a leading consultancy that has been at the forefront of 21 CFR Part 11's interpretation since it was first issued in 1997.