Periodic review schedules, that are created and approved in the system, are automatically displayed in the Validation Calendar. The validation calendar is available to users from the Dashboard and will display upcoming, delayed, completed, and WIP (work in progress) periodic reviews. Through the validation calendar, users are able to view, in real time, when a periodic review is required for any given system, or process. As noted previously, once the periodic review is completed, the system will dynamically update the validation calendar to indicate that the schedule task has been finished.
Automatic notification and messaging facilitates for upcoming periodic review, improves efficient inter-departmental communications, enabling staff members to be informed of upcoming periodic review tasks on a timely basis and in a consistent manner. Notifications are sent via email, as well as through ValGenesis’s internal messaging mechanism. ValGenesis also provides “watchdog-like” functionality which issues alerts, not only for the upcoming periodic review tasks, but for the delayed periodic review task and performs escalations. The Validation calendar available in ValGenesis helps to mitigate the common validation error cited in FDA warning letter, for missing period review and revalidation schedules.