I vaguely recall having heard a discussion on this area but can't recollect if the feature exists. If it does how does it work, what needs to be implemented?
Yep, it's supported. Here's a blurb from our vendor process assessment form:
Describe your approach to complying with 21 CFR Part 11.
21 CFR Part 11 refers to the U.S. Food and Drug Administration’s (FDA) guidelines on electronic records and electronic signatures. It defines the criteria under which electronic records and electronic signatures are considered trustworthy, reliable, and equivalent to paper records.
Rational Change provides electronic signature capability for change requests (defects, enhancements, or any other type of data you might want to manage). The system can be configured to capture electronic signatures for specific users or roles at different points in the change request process, for example, a change request may require one or more signatures before it can be assigned or resolved.
To add an e-signature, the user must enter a user ID and password that uniquely identifies him or her. If the user ID and password are authenticated, the system captures the user’s name, date and time, and meaning of the signature, and stores this information as an attribute of the change request.
All changes to a change request are logged in an audit trail. The Rational Change lifecycle can be used to enforce a sequence of steps and events.
Only authorized users can login to Rational Change, and their access is restricted by role.
Describe how Rational Change is designed to comply with 21 CFR Part 11.
Rational Change is a closed system that requires user authentication. Data is stored in a secure relational database management system (RDBMS), either IBM Informix or Oracle Database. Rational Change is configured using a flexible process that defines forms, attributes, and a lifecycle for change requests, including pre-conditions and triggers. The electronic signature requires re-authentication of the user ID and password so that no one can “sign” a document at another person’s logged-in session. When a change request is signed, the signature is stored on the change request, and information about the signature is stored in the secure database so that the signature can be validated.
Is your software fully compliant with 21 CFR Part 11?
Rational Change supports electronic signatures as described above, but it is important to note that companies using Rational Change must define procedures to ensure use consistent with 21 CFR Part 11.
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