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SASŪ Solutions for Addressing 21 CFR Part 11 Compliance -- the P21 Biomedical Knowledge Platform
Edward Helton, SAS Institute
Patricia Halley, SAS Institute
David Handelsman, SAS Institute

The heart of CFR Part 11 is less than three pages long - but the impact on regulated industries has been enormous. SAS' P21 Biomedical Knowledge Platform offering has been designed to specifically address the issues associated with 21 CFR Part 11 and the F DA's Guidance for Industry documents. P21 provides these capabilities while offering an enhanced operating environment for managing clinical data, programs, logs, documents and reports. Careful consideration has been given to the intended performance wit h respect to data warehousing, analysis and reporting, electronic submissions and related e-signature requirements. The development of P21 adheres to the industry standards for both process and quality management. Application of both process and quality management has assured that the software meets the intended requirements of the system's 21 CFR Part 11 functionality. This presentation will discuss using P21 to assure that electronic records are "trustworthy, reliable, and generally equivalent to p aper records and handwritten signatures.