ATReview
Identify, analyze, review, and approve GxP System audit trail records
ATReview revolutionizes traditional audit trail review management by turning manual periodic reviews into real-time, digital processes. Specifically designed for the Life Sciences industry, it provides a validated solution that streamlines audit trail review activities while ensuring compliance with regulatory standards.
Enhance efficiency and free up critical resources
Performing audit trails record reviews for GxP systems is essential to uphold best practices and ensure patient safety. However, the complexity and growing number of systems make the analysis and review of GxP audit trail records increasingly difficult. As the execution of audit trail record reviews becomes more challenging to manage, defining a thorough periodic review schedule and analyzing the extensive data involved is both time-consuming and labor-intensive. This process demands highly skilled resources, pulling them away from other critical projects, at a time when such expertise is becoming more scarce in the market.
Smart automation for instant insights
ATReview enables organizations to replace manual GxP system audit trail reviews with intelligent automation. This fully customizable application consolidates all your GxP relevant audit trail data into a single, user-friendly interface. With our cloud technology, audit trail records from GxP systems are examined for relevant parameter changes and automatically sent to ATReview, where all relevant parameter changes can be analyzed, reviewed, and approved in real-time.
Customized monitoring and secure, tamper-proof logs
Organizations can choose which GxP systems to gather audit trail data from and define their own relevant parameters. ATReview then automatically identifies actionable items and alerts the appropriate users. With continuous, real-time monitoring of your audit trail data for relevant parameter changes, the need for cumbersome periodic reviews and retrospective data tracking is eliminated. Access to relevant audit trail records is securely managed through assigned privileges within the ATReview application, with all record review actions recorded in real-time activity logs, ensuring a fully contemporaneous and tamper-proof audit trail.
Why choose ATReview
- Standardization
Predefining your relevant parameter changes and establishing the data critical to your processes allows for a completely standardized audit trail review across computer systems regardless of the user involved.
- Automation
Automate both the transfer of relevant audit trail data to the ATReview application and the detection of incomplete and non-attributable record data in real time.
- Compliance
The move from manual periodic review to automated continuous monitoring means that you are permanently ‘audit ready’ and greatly reduces the risk of non-compliance.
- Continuous Monitoring
Remove the risk of non-compliance or negative impacts with continuous monitoring and real time alerts. ATReview highlights record gaps instantly allowing for immediate corrective action.
- Filtering & Sorting
With ATReview’s bespoke configuration abilities, only monitor relevant parameter changes from registered GxP systems and automatically remove all data not relevant for audit trail review.
- System & User Tracking
ATReview gives organisations full visibility and control of registered GxP systems and assigned responsible owners through an easy and secure configurable System Registry.
- Tamper Proof & Secure
ATReview provides a real time and uneditable activity log of all actions related to data record reviews. This digital footprint and secure e-signature features, supports your data integrity regulatory obligations.
- Resourcing
Remove vast amounts of manual and time-consuming data extraction and mining during periodic reviews. Eliminating much of this manual work being carried out by highly skilled personnel, ATReview application significantly improves internal resourcing.
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