Test groups represent a GMP critical document that, according to GMP guidelines and FDA regulations, must be subject to a strict approval process. To ensure compliance with regulatory requirements, Life Sciences Quality Control & Assurance introduces test group approval and activation steps.
In Life Sciences Quality Control & Assurance > Setup > Quality control > Test groups, test groups can be approved and activated by clicking the Approve and Activation buttons:
When a test group is approved, the Approved checkbox is automatically ticked, and the approver’s name is stored in the Approved by field in the Test groups form.
When the test group is activated, the Active checkbox is automatically ticked. The activation period is defined in the From date and To date fields; if the fields are blank the test group is always considered active. The system prevents the activation of two versions of the same test group during overlapping periods.
If test groups are subject to advanced approval rules, it is possible to configure a test group approval workflow.
Users can specify if the test group approval and activation should be secured via electronic signature by ticking the Signature required checkbox for the Approve test group and Activate test group requirements in the Electronic signature requirements form (Organization administration > Setup > Electronic signature > Electronic signature requirements). If the electronic signature requirement for test group approval and/or activation is enabled, the Sign document form is displayed when clicking the Approve/Activate buttons. Users need to:
Enter a Reason code (for example, “QC approval”) and a comment (optional/mandatory as per relevant configuration), then click OK.
Enter the electronic signature Password and click OK.
Note
The electronic signature leverages Microsoft Dynamics 365 Finance & Supply Chain Management standards, enhanced by STAEDEAN Life Sciences features available in the Life Sciences Supply Chain Management module:
If the Block editing parameter is enabled in Life Sciences Quality Control & Assurance > Setup > Life Sciences Quality Control & Assurance parameters > Quality management, a test group in Approved status cannot be modified.
To modify an approved test group, users must remove the approval by clicking Approve and enabling the Remove approval parameter. Otherwise, a new version of the same test group must be created and modified as needed.