The current periodic review and revalidation scheduling processes are predominantly paper based and manual. Validation departments in regulated firms are faced with the challenge of efficiently managing the periodic review and revalidation tasks by coordinating with other department stake holders. In the manual process, managing periodic review schedules is a complex task that is prone to human error. Managing an effective periodic program to ensure that all critical GxP processes, systems, instruments, equipment, etc. are revalidated on time is complex and difficult to maintain. Failing to revalidate critical GxP entities (Instruments, Equipment, Software etc.) and GxP Processes could result in FDA issued warning letters and citations.

“Systems and Processes should be periodically evaluated to verify that they are still operating in a valid manner”. Source: ICH Q7A GMP Guidance

Once a periodic review schedule has been created in the scheduler module in ValGenesis, it is routed through a configurable approval workflow. Upon approval of the schedule, the schedule will be automatically written to the Validation calendar. The selected user groups will be alerted of pending and delayed periodic review tasks through the Task Alert Feature and/or through the corporate e-mail system. By alerting groups of users, ValGenesis eliminates the possibility of failing to periodically review and revalidate critical GxP entities on time.

The approved periodic review/revalidation schedules will be available in the calendar for information to all the users corporate wide. The approved schedule can be edited with appropriate permission; the edited schedule will be routed through a configurable workflow for approval. Approval workflow improves the communication among various groups involved in the periodic review and revalidation tasks. This would minimize the impact on validation schedules, or other planned tasks.

Approved periodic review and revalidation schedules are automatically written to a central validation calendar. The validation schedule calendar can be viewed by the week, month or year. Group members can add notes in the calendar, making the revalidation and periodic review tasks more collaborative.