See our Whitepaper for more information on how Dropbox can help aid in your compliance efforts with 21 CFR Part 11. While ultimately it’s up to you to make sure that you’re complying with your regulatory obligations, you can use these reports to conduct your own risk analysis under 21 CFR Part 11. While these audits don’t focus on 21 CFR Part 11, their purpose and objectives are similar to those of Part 11, and serve to help ensure security, confidentiality, integrity, availability, and privacy of your data. These reviews occur at least annually and are conducted by globally-respected audit and security firms that are independent and thorough in their inspections. How does Dropbox aid in my compliance efforts under 21 CFR Part 11 for electronic records?ĭropbox uses independent third-party auditors to test our systems and controls against some of the most widely-accepted security standards and regulations in the world, such as SOC 1 and SOC 2 Type II, ISO/IEC 27001, and ISO/IEC 27018. The FDA also issued guidance for Part 11 in August 2003, which can be found here. The Electronic Records section of Part 11 sets forth the requirements for the controls of closed and open electronic record-keeping systems, as well as requirements for establishing a link between signatures and electronic records.įor more information about this regulation, including the list of requisite procedures and controls, visit the Electronic Codes of Regulations page.

Part 11 of Title 21 sets forth the criteria under which FDA considers electronic records and signatures to be trustworthy, reliable, and generally equivalent to paper records and handwritten signatures executed on paper. Title 21 of the Code of Federal Regulations (CFR) governs food and drugs within the United States for the Food and Drug Administration (FDA), the Drug Enforcement Administration, and the Office of National Drug Control Policy.

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