Medical Device Suite manages automatically the history of all changes on each of data. Our software offers you a total traceability without any effort about date, time, author, type of actions. You can then know at any time who did a change, when and where in your study.
Very fine traceability functionality allows for example to identify with two clicks what has changed between two sessions of risk analysis of or two milestones project, or to highlight all the post-market data that are taken into account in the analysis of risk during an audit or inspection.
Our ISO 14971 risk survey software is also customized to prevent users from changing the archiving data to make them tamper-proof.
This management of the automatic audit trail is visible in live by a simple right click on each data:
Just as it is possible to perform queries on traceability data, it is possible to run reports by selecting filters using this traceability data.