Sign and Authorize System Changes

Auditor license is required for this feature.

If an electronic signature, or an electronic signature and authorization signature, is required for a system change1 Aids compliance with FDA 21 CFR part 11. you must complete the required confirmation box(es) whenever a change is required.

All electronic signatures and authorization signatures are recorded in the Event Log.

1. Make the required change in the setting.
2. Click on Save.
3. Select from:
   If the System Change Requires an Electronic Signature
   

   1. Enter a meaningful reason for the setting change (a reason must be entered).
      
   2. Complete your electronic signature:
      • User ID
      • Password.
   3. Click on Sign.

   The change in the setting has now been signed for.

   If the System Change Requires an Electronic Signature and an Authorization Signature

   1. Enter a meaningful reason for the setting change (a reason must be entered).
      
   2. Complete your electronic signature:
      • User ID
      • Password
   3. Click on Sign.
      The Authorization required dialog becomes active.
      Once your electronic signature has been accepted you cannot change the reason for change text.
   4. Complete the electronic Authorization signature:
      • User ID
      • Password
   5. Click on Authorize.

   The change in the setting has now been signed for and authorized.

Note:  When you enter a password on a web page, it offers by default to save your login credentials. As this feature may cause a security risk, ensure not to save your Data Reviewer passwords (both Initial login and Signature and authorization login) by clicking the Never option.