Automated Periodic Review and Re-validation Schedules
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.
Periodic review schedules can be easily created through the scheduler module available in ValGenesis.
- Each periodic review/revalidation schedule created is highly configurable, allowing a user to specify the due dates, frequency of the revalidation, grace period, alert notification, and approval workflow
- The system sends out e-mail notifications and alerts to required user groups about upcoming periodic review and revalidation tasks
- One time and recurring periodic review and revalidation schedules can be created
- Periodic review schedules can be created for a Validation type, Load type etc
- Periodic review/Revalidation tasks can have the same, or staggered due dates
- The system routes the proposed periodic review schedules for approval through a controlled workflow
- Improves communication between stake holders across departments
- Minimizes impact on production or other previously scheduled tasks
- By implementing the scheduler module available in ValGenesis, companies can achieve an efficient periodic review program and ensures critical GxP Process, Instrument, Systems, etc. are periodically reviewed and revalidated on time, to eliminate the possibility of missing the revalidation tasks due to human error.
- ValGenesis improves coordination among various groups such as Quality Assurance, Technical Services, Validation, and Manufacturing etc. to complete the validation tasks on time.
- Approval and agreement of any periodic review and revalidation schedule between different departments is suggested to minimize the impact of these validation activities on the production schedule.
- Scheduler function in ValGenesis improves the communication between the stake holders for the upcoming periodic review and revalidation schedule tasks.
- Selected Groups (groups selected at the time of schedule creation) will be alerted of upcoming or delayed periodic review and revalidation tasks automatically, through corporate email system.