Move from manual management to automated organization of event terms by RSI type and version number.
All RSI information will be closely integrated with safety systems for seamless and accurate auto-listedness.
Provide RSI configuration of terms mapped at product family level as well at product indication level with accuracy.
Use logic to define complex scenarios and assessments at System level and datasheet level. Special scenario and standard condition accuracies while making this closer to real-life assessments.
Assisted Medical Review
Automate and digitize medical assessment of listedness by providing accurate and comparable listedness screens.
RSI assessments made accurate by comparing listedness within the reporting window and RSI effectiveness version.
Audit ready always
Audit trail in accordance with 21 CFR part 11. Label discrepancies identified immediately.