From a GMP perspective, the approval and validation of quality orders are critical steps. According to GMP guidelines, these activities require at least two sign-offs.
While standard D365 F&SCM provides a single step for the validation of quality orders and consequent batch release, STAEDEAN Life Sciences allows configuring a quality order approval workflow.
Workflow requirements can be activated in Life Sciences Quality Control & Assurance > Setup > Life Sciences Quality Control & Assurance parameters > Quality management tab:
If the Quality order approval parameter is enabled, the completion of the workflow is required to proceed with quality order validation.
If the Quality order approval parameter is disabled, the quality order can be validated without executing the workflow.
The quality order approval workflow template can be configured in Life Sciences Quality Control & Assurance > Setup > Life Sciences Quality Control & Assurance workflows and supports:
Conditions (for example, different steps can be applied depending on the item type).
Review activities, such as peer review (multiple review steps can be configured).
Approval tasks.
STAEDEAN Life Sciences workflow templates leverages D365 F&SCM workflow engines and standards. Please refer to the D365 F&SCM training material for information regarding the configuration of a workflow instance.
To control whether quality order editing is permitted during workflow processing, configure the Block quality order editing setting located at Life Sciences Quality Control & Assurance > Setup > Life Sciences Quality Control & Assurance parameters > Quality management:
If the Block quality order editing parameter is disabled, the quality order, its lines, and line results will remain editable both during the processing of the approval workflow (such as when the status is Pending approval) and after it has been completed (that is, when the status is Completed).
When the Block quality order editing parameter is enabled, users cannot change the quality order, its lines, or their results during the approval workflow (such as while it’s in the Pending approval state) or after it’s finished (Completed state). However, you can still edit the quality order if the workflow status is Not submitted, Pending complete, Returned, or Change requested.