HiARSIC

Know HiARSIC

HiARSIC / RSI Management System (RSI) is an integrated system that enables the Automated Update of RSI to enhance efficiencies in process by improving productivity, reducing workload, ensuring compliance by integrated key processes globally with clear visibility.

Features

Automate RSI
Move from manual management to automated organization of event terms by RSI type and version number.

Integrated Solution
All RSI information will be closely integrated with safety systems for seamless and accurate auto-listedness.

Flexible Configuration
Provide RSI configuration of terms mapped at product family level as well at product indication level with accuracy.

Complex Logics
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.

Active window
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.

Benefits

Efficiency

  • Significantly reduce medical review time
  • Sync feature brings RSIs automatically
  • Bulk Assessment for legacy cases
  • Reduces re-work

Accuracy

  • Product Level and Indication Level accuracies
  • Time level accuracies
  • Special scenarios and standard condition accuracies

Compliance

  • Audit Ready at all times
  • Label discrepancies identified immediately
  • Audit trail in accordance with 21 CFR part 11

Transparency

  • Clear visibility across indications, products…
  • View actual RSI
  • Provides view of previous RSI versions
  • Safety vs. HiARSIC assessments
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