CFR Part 11 Module

Nintex should consider creating a pre-built report or an optional add-on module option within Nintex eSign designed to help organizations achieve compliance with FDA's 21 CFR Part 11 regulations. This module could features such as prepackaged account configurations, signature-level credentialing, and signature manifestation, which includes the printed name, date/time, and signing reason. Examples of this in the competitive eSign market today are DocuSign's Part 11 module, the Validator for Life Sciences, which simplifies validation testing and documentation required for Part 11 compliance by providing automated reports with detailed test results.