Important Notice: Our web hosting provider recently started charging us for additional visits, which was unexpected. In response, we're seeking donations. Depending on the situation, we may explore different monetization options for our Community and Expert Contributors. It's crucial to provide more returns for their expertise and offer more Expert Validated Answers or AI Validated Answers. Learn more about our hosting issue here.

Is the non-repudiation letter solely for use during the testing period or is it carried forward to the production system environment?

April 26, 2017Environment forward letter non-repudiation period production system Testing

0

Posted

Is the non-repudiation letter solely for use during the testing period or is it carried forward to the production system environment?

1 Answer

0

Posted

A. The non-repudiation letter is necessary to enable your corporation to submit electronic submissions to the FDA. It is mandated by 21 Code of Federal Regulations (CFR) 11 and specifically referenced in 21 CFR 11.100 (c) (2). A copy of the non-repudiation letter sent to the Office of Regional Operations (ORO) shall be provided to the FDA ESG Staff. The use of the non-repudiation letter applies to electronic submissions submitted both through the FDA ESG production system and via the mail.