Conducting periodic reviews on GxP systems, assets and/or processes that have already been validated is a critical aspect in any validated environment. It is important to review a system or process for changes – both physical and procedural – in order to verify that a system or process is operating as expected. For the most part, management of periodic reviews is achieved using spreadsheets and other paper-driven tools. This in turn equates to reliance upon a single user or group of users to ensure that periodic reviews are completed on time and documented accordingly. Through this reliance on human interaction the possibility of errors heightens and risk increases. Through ValGenesis users are able to create periodic review schedules that automatically alert user groups of any upcoming or delayed periodic review tasks. In this way human errors are removed from the process ensuring that users are aware in real time of the status of any periodic review. Alert notifications for upcoming and delayed periodic review tasks are automatically sent to impacted user groups through corporate email, so users are not required to login to ValGenesis every day
Optional approval for scheduled periodic review
When a periodic review schedule is created in the system, the creator of the periodic review has the option to route the schedule through an approval process. Optional approval gives users the flexibility to route critical periodic reviews for approval, while allowing non-critical periodic reviews to be created without approval. If a periodic review is routed for approval and rejected, the creator of the periodic review can make the required changes before routing the schedule back for approval.
Automated alert notification for upcoming periodic reviews
One of the key benefits associated with creating periodic reviews through ValGenesis is that user groups are automatically notified of upcoming periodic reviews through corporate email. This assists users in ensuring that critical systems and processes are reviewed in a timely manner thereby reducing the risk of non-compliance.
Escalation process for the delayed periodic review tasks
Responsible user groups are automatically notified with the details of delayed periodic review tasks through corporate email. This assists users in ensuring that critical systems and processes are reviewed in a timely manner thereby reducing the risk of non-compliance.
Real-time validation calendar
Any periodic review schedule that is created and approved in the system is 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.