What is a 21 CFR Part 11 Letter of Certification? • As part of the compliance process, all life science companies must file what’s called a letter of non-repudiation agreement with the FDA. This letter must be on file with the organization, or the organization will deem you not in compliance. • According to the FDA’s website, “A letter of Non-Repudiation Agreement for digital signatures must be submitted to the FDA prior to registering as a transaction partner for the FDA ESG. The letter must be submitted (preferably on company letterhead) and signed with a traditional handwritten signature. Users requesting a new ESG account must send an electronic copy of their Letter of NonRepudiation to ESGHelpDesk@fda.hhs.gov. In addition, users must send a physical copy to the FDA. Users must send a hard copy within 2 weeks or your account may be disabled.” Where Should You Send a 21 CFR Part 11 Letter of Certification? • According to the FDA, all letters of non-repudiation agreement should be sent to the following address: • Lowell Marshall Electronic Submissions Gateway U.S. Food and Drug Administration 3WFN, Room 7C34 12225 Wilkins Avenue Rockville, MD 20852
