What’s 21 CFR Part 11?
Title 21 of the Law of Federal Regulations (CFR) governs food and medicines within the United States for the Food and Drug Administration (FDA), the Drug Enforcement Administration, and the Office of National Drug Control Policy. Part 11 of Title 21 sets forth the criteria under which FDA considers electronic records and autographs to be secure, dependable, and generally original to paper records and handwritten autographs executed on paper.
The Electronic Records section of Part 11 sets forth the conditions for the controls of unrestricted and open electronic record- keeping systems, as well as conditions for establishing a link between autographs and electronic records.
For further information about this regulation, including the list of needful procedures and controls, visit the Electronic Canons of Regulations runner. The FDA also issued guidance for Part 11 in August 2003, which can be plant then.
How does Dropbox aid in my compliance sweats under 21 CFR Part 11 for electronic records?
Dropbox uses independent third- party adjudicators to test our systems and controls against some of the most extensively- accepted security norms and regulations in the world, similar as SOC 1 and SOC 2 Type II, ISO/ IEC 27001, and ISO/ IEC 27018. These reviews do at least annually and are conducted by encyclopedically- admired inspection and security enterprises that are independent and thorough in their examinations.
While these checkups do n’t concentrate on 21 CFR Part 11, their purpose and objects are analogous to those of Part 11, and serve to help insure security, confidentiality, integrity, vacuity, and sequestration of your data. While eventually it’s up to you to make sure that you ’re complying with your nonsupervisory scores, you can use these reports to conduct your own threat analysis under 21 CFR Part 11.
See our Whitepaper for further information on how Dropbox can help prop in your compliance sweats with 21 CFR Part 11.
Which Dropbox checkups, reports, and instruments can help in my compliance sweats?
. Dropbox provides guests with several types of inspection reports and instruments that attest to the effectiveness of the controls Dropbox has enforced. The list of these reports and instruments can be plant then. Those most applicable to 21 CFR Part 11 are addressed in our SOC 3 report and ISO 27001 instrument.
Farther details regarding these controls can be plant in our SOC 2 inspection report, which is available upon request through our deals platoon or (for being Dropbox Business guests) support.
See our Whitepaper for further information on how Dropbox can help prop in your compliance sweats with 21 CFR Part 11.
What about HelloSign and electronic autographs?
At this time, Dropbox and HelloSign don’t offer compliance support under 21 CFR Part 11 specific to electronic autographs.
Part 11 of Title 21 CFR (Code of Federal Regulations)
Misbehave with FDA digital hand regulations and induce trusted documents
FDA regulations, specifically Part 11 of Title 21 of the CFR, define the criteria under which the FDA considers electronic records, electronic autographs, and handwritten autographs inked in electronic records to be dependable and generally original to paper records and inked handwritten autographs on paper.