Workflow management in GxP software refers to structured management and automation of workflows in accordance with regulatory requirements to ensure compliance with standards and improve efficiency in the execution of critical processes. This includes defining workflows, assigning tasks, monitoring progress and ensuring that all steps and decisions are documented and auditable.
The application area of workflow management is electronic form processes. Four important examples of form processes in the GxP area are:
Request for changes (change request): This form process involves the submission, review and approval of change requests for documented procedures, processes or systems in accordance with GxP standards.
CAPA plan (Corrective and Preventive Action): This form process includes the collection, investigation, planning, implementation and review of corrective and preventive actions to resolve issues and prevent future incidents that may violate GxP requirements.
Deviation Report: A form process for reporting and investigating deviations or nonconformities during production, laboratory work or clinical studies in accordance with GxP requirements.
Protocol for qualification/validation (Qualification/Validation Protocol): This form is used to support the planning, execution and documentation of qualification or validation activities for equipment, systems or processes according to the GxP guidelines.
