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Status Unlikely to implement
Categories Integrations
Created by Guest
Created on May 5, 2017
Merged idea
This idea has been merged into another idea. To comment or vote on this idea, please visit APP-I-1049 Provide tools for Change Control.

FDA Electronc Signature Approval & Change Control Merged

See my support request....Requirements need to be reviewed and approved by a defined group of roles.   The tool needs to allow for electronic signature that supports 21 CFR Part 11 requirements.   The tool cannot allow the requirement to be changed without a defined change control.  In other words, if requirement 001 states "the system shall require the user to enter their maiden name" and that requirement is approved and baselined under change control.   Aha needs to ensure that no one can go into the requirement and change it to "the system shall require the user to enter their mother's maiden name".   It's not a significant change - it's really just clarifying text - but - it's a change.  And an auditor will look at the timestamp of the change and see that it occurred after the last approved version of the requirements.   So, the tool workflow needs to be established such that any changes to the requirements necessitate a re-approval with appropriate change control descriptions, impacts, etc.