QMS Workflow Engine Enhancements

This release introduces a powerful enhancement to the QMS Workflow Engine that dynamically configures and assigns QMS Roles based on the type and category of each record. Designed to ensure the right people are involved at each stage of a CAPA or investigation, the new functionality integrates Record Types, Workflows, Teams, and Forms to drive intelligent, metadata-based user assignments.

Now, when initiating a workflow (e.g., CAPA, Investigation), the system uses the record’s metadata, such as Type and Category, to automatically determine the correct Teams and associated Authority Types (Process Owner, Contributor, Approver).

For instance, a CAPA categorized under ‘Technology’ would automatically involve the Head of IT and Technical Support as lead investigators, as per the configurations, ensuring a faster, more accurate response aligned with the organization’s quality protocols.

This enhancement empowers Administrators to configure dynamic review groups that are automatically assigned to workflow steps based on record metadata such as category, type, and subtype. The system supports hierarchical mapping of Record Types and uses these to determine the appropriate Teams and Authority Types for each workflow.

Within each Team, users can be assigned one or more Authority Types, such as Process Owner, Contributor, or Approver, etc., representing the specific role or ‘hat’ they wear in the context of a given record.

These Authority Types are further defined by their level of involvement (Assigned, Escalation, Informed), ensuring accurate participation across the workflow. Workflow Configuration Profiles provide control over workflow behavior, including step order, visibility of fields, authority-to-action mappings, and targeted notifications.

When a workflow is initiated, the system notifies the authority types in each stage (depending on the notification configurations). The authority then has to perform the relevant actions and transition the record to the next stage.