Conducting periodic review 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, paper-based management of periodic reviews is achieved through the use of spreadsheets and other paper-driven tools. Traditional paper-based periodic review management relies on a single user or group of users, to ensure that periodic reviews are completed on time and documented according to the requirements of approved procedures. Through this reliance on human interaction, the possibility of errors and compliance risk increases.
- The creator of the periodic review schedule has the option of routing the schedule through an approval process.
- Configurable approval gives users the flexibility to route critical periodic reviews for approval, while allowing non-critical periodic reviews to be created without approval.
- User groups are automatically notified of upcoming periodic review tasks through corporate email.
- ValGenesis ensures that critical systems and processes are reviewed in a timely manner therefore reducing the risk of non-compliance.
- Delayed periodic review tasks can be escalated to selected user groups through corporate email to avoid the risk of non-compliance.
- 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.