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Electronic Signature Exceptions

Article ID: 395  |  Last updated: 26 Apr, 2017

If electronic signatures are enabled in Helix ALM, users are prompted to enter their username, password, and a reason for making the change when adding, editing, or deleting items. This electronic signature is saved with the items and helps enforces compliance with business or regulatory processes, such as 21 CFR Part 11.

Helix ALM can be configured to require users to enter a change reason with the following exceptions:

  • Creating items using email import
  • Creating items using SoloSubmit
  • Any item modifications using a SOAP-based interface
  • Escalation rules that modify an item
  • Attach and fix actions performed in Surround SCM except when adding or editing items from the Helix ALM Browser dialog box

To ensure compliance, configure projects so users cannot add, edit, or delete items using these actions.

Article ID: 395  |   Last updated: 26 Apr, 2017
exceptions electronic signature

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