Food and Drug Administration (FDA) - 21 CFR Part 11

21 CFR Part 11 - Title 21 CFR Part 11 of the Code of Federal Regulations deals with the Food and Drug Administration (FDA) guidelines for electronic records and electronic signatures .  Part 11 defines the criteria under which electronic records and electronic signatures are considered to be trustworthy, reliable and equivalent to paper records.  Part 11 requires drug makers, medical device manufacturers, biotech companies, biologics developers, and other FDA-regulated industries, with some specific exceptions, to implement controls, including audits, system validations, audit trails, electronic signatures, and documentation for software and systems involved in processing electronic data.

1. If your protocol is a partnership with a pharmaceutical/biotech company, that organization may take ownership/management/security of the computing devices used at Yale. Compliance may only be required if Yale computing devices or storage media are used.
2. There may be requirements for certification that the EHR (Electronic Health Record) application you are using is compliant. Currently, the YNHH Logician EHR is not compliant and there are no plans to bring it into compliance.

Related links

• Compliance with Department of Veterans Affairs (VA) research data security
• Offices of Grant & Contract Administration