I suggest you ...

Provide support for electronic signatures which can meet the requirements of 21 CFR Part 11.

Provide the means for a tester to electronically sign their results. It isn't enough that MTM 2015 shows the test runner in the test outcomes unless it can be demonstrated that the system positively identifies the person that ran a test and that person cannot be impersonated. Test records need to show who did what, when.

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Thomas Bolieu shared this idea  ·   ·  Flag idea as inappropriate…  ·  Admin →

2 comments

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  • Barry commented  ·   ·  Flag as inappropriate

    We need the ability to add a electronic signature trigger field in a work item that writes a signature (login user) & date\time stamp to separate read-only fields that will satisfy 21 CFR Part 11.

  • Pam Davis commented  ·   ·  Flag as inappropriate

    I worked in QA for a software development company that is now having to be in compliance for the FDA 'electronic signatures' compliance that Thomas explained above. PLEASE add this enhancement, this is so time consuming generating larg test documents, adding signature lines to EACH TEST, then getting the manual signatures. A time consuming NIGHTMARE. Please add this!!!

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