The Code of Federal Regulations Title 21 Part 11 is a significant milestone in the U.S. FDA's effort to improve the efficiency of the development, submission, review and approval process for new drugs. 21 CFR Part 11 requires that the drug sponsor perform validation of systems that support the maintenance and submission of electronic records. This white paper discusses how SAS Drug Development assures the reliability of electronic records through a predefined system development life cycle (SDLC) executed by a highly qualified staff. The paper also includes a step-by-step explanation of how SAS Drug Development was specifically designed to comply with each subsection of 21 CFR Part 11.
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