21 CFR Part 11 is a Food & Drug Administration (FDA) regulation, enacted in 1997, which covers electronic records/electronic signatures when used for FDA regulated activities. Part 11 describes the process for creating, modifying, maintaining, archiving, retrieving, and transmitting electronic records, and the use of electronic signatures when complying with the Federal Food, Drug, and Cosmetic act or any other Food and Drug Administration regulation. The focus of this regulation is to ensure the integrity, trustworthiness/reliability, traceability, and accountability of a company's record management process.
Domino provides the tools to help administrators and system/application designers to create applications that meet the compliance requirements. The purpose of this paper is to provide technical guidance to our customers who are building or modifying applications that may be used as part of the compliance process. The focus of this paper is on Domino as an application development platform with the Notes client. The instructions and guidance within this document highlight the many tools and options available within Domino to assist our customers in building compliant and secure applications for their environment.
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