If you do not submit a rejection letter to the FDA, you will be considered non-compliant, even if you have followed all the other steps you request. This could lead to receipt of Form 483 as well as warning letters from the FDA. If the situation is not corrected, you risk damaging your company`s reputation and possibly losing business, as well as other FDA measures. Fortunately, submitting a non-rejection letter is easy and takes very little time. The FDA has strict regulations that apply to companies in the life sciences industry, especially when it comes to electronic records and signatures. An essential part of compliance with these regulations is the filing of a 21 CFR Part 11 certification letter, better known as a non-repudiation agreement letter. For those who don`t know what these letters do, how to write one, and other details, this guide outlines what you need to know. The FDA has made two sample letters available on the organization`s official government website. Both contain placeholders in parentheses that indicate where you need to provide information and what information is needed. The two examples of letters from the non-repudiation agreement can be found here: www.fda.gov/industry/about-esg/appendix-g-letters-non-repudiation-agreement As part of the compliance process, all life sciences companies must submit a non-repudiation agreement to the FDA. This letter must be filed with the organization, otherwise the organization will believe that you are not complying with the regulations. The non-refusal agreement allows the FDA to receive electronically signed submissions in accordance with Part 11.100 of the Code of Federal Regulations (CFR) 21. If you answered yes above, 21 CFR Part 11 applies to you, and you must complete and send a letter with a non-rejection agreement to file with the FDA.

According to the FDA, all letters of the non-repudiation agreement must be sent to the following address: Note: Directories and subdirectories cannot begin with the “”. (period) Sign. The right LMS is crucial – as an electronic system, it also needs to be validated and compliant with the rules. At eLeaP, we have designed our learning management system to offer the best capabilities, but also to comply with 21 CFR Part 11 rules. It is fully validated and adapted to use. Contact us today to find out more or to arrange your individual consultation… When choosing a provider, look for timestamps and other features that automate the audit trail for you, as well as password protection and other advanced security tools… [Name of company representative] [Title of company representative]. . . Digital certificates ensure a private and secure submission of electronic documents.

The digital certificate links the owner`s name and a pair of electronic keys (a public key and a private key) that can be used to encrypt and sign documents. If your company follows all the regulations it contains and can prove to an auditor the validity of electronic signatures, the FDA will generally accept these electronic signatures instead of traditional paper signatures… Table 5: Aspects of the Submission Process and Help and Information Contacts Prior to registration as a Transaction Partner for the FDA`s ESG, a non-repudiation agreement letter for digital signatures must be submitted to the FDA. The letter must be submitted in paper form (preferably on company letterhead) and signed with a traditional handwritten signature. The letter should be sent to*:. . A non-repudiation agreement letter must be submitted to the FDA. See Appendix H, the Sample Letters of the Rejection Agreement, for examples of letters. . . .

Did you know? The FDA issued the final Part 11 Regulations in March 1997 to establish criteria for FDA acceptance of electronic records and electronic signatures. . * See Appendix B., Creating .tar Files and Compressing Files for Submission. Table 3: Delivery Protocol Selection Considerations. Regulation is a very important part of fda digital health for pharmaceutical companies, medical device suppliers, etc. Unfortunately, it is also one of the most complex. .