Electronic Signatures in DOORS Next Generation
One answer
You can create a change request in the Jazz work item system and sign it. In V6.0.0 you can associate the change request with a change set in DOORS NG when you have enabled configuration management for that project area.
In the current release plan (6.0.1) we are working on extending this to control delivery of DOORS NG change sets. In other words, one could make it a precondition of delivery that the change request has been approved. And the approval can require a FDA-compliant electronic signature.
For more information (and to follow the work) you can subscribe to this: 44277: CM: Requirements Change Management
In addition, a lighter-weight DOORS NG review and approval mechanism provides evidence of review (and if desired, approval). However this is not designed to meet FDA CFR 21 part 11 requirements.
In the current release plan (6.0.1) we are working on extending this to control delivery of DOORS NG change sets. In other words, one could make it a precondition of delivery that the change request has been approved. And the approval can require a FDA-compliant electronic signature.
For more information (and to follow the work) you can subscribe to this: 44277: CM: Requirements Change Management
In addition, a lighter-weight DOORS NG review and approval mechanism provides evidence of review (and if desired, approval). However this is not designed to meet FDA CFR 21 part 11 requirements.