Foresight® Codex Up-Version

Foresight® Codex Up-Version is a MedDRA up-versioning tool for Argus SafetyTM versions 7 and 8 that provides a robust solution for life sciences companies that need to up-version MedDRA/MedDRA J coded terms in Oracle Argus Safety™ to new dictionary versions. Regular up-versioning of MedDRA-coded safety data streamlines regulatory compliance and enhances signal detection capabilities by standardizing safety data.

The tool supports a proven workflow built around industry best practices for analyzing, reviewing/updating, and batch up-versioning MedDRA coded terms using a friendly web- based interface. Foresight® Codex Up-Version 7.0 is standard for all customers using Argus SafetyTM hosted in the Foresight Cloud®

Features – At a Glance

 
  • Fully integrated with Oracle Argus Safety™ 7.x and 8.x
  • Supports any version of  MedDRA
  • Full support for Japanese coding with Argus J and MedDRA J
  • Industry proven workflow:
    • Analysis of coded term changes
      • Configurable analysis algorithm
      • Changed terms marked for  review
    • Review of term up-versioning instructions
      • Interactive review of term changes
      • Manual coding can override algorithm
    • Batch application of up-version instructions to Argus Safety database
      • Fast execution minimizes downtime
      • Preserves Argus audit trail integrity
  • Comprehensive reports of up-version decisions and results
  • Complete set of quality documentation to support fully validated use of Foresight® Codex: Up-Version
  • 21 CFR 11 and HIPAA compliant
  • Friendly web-based user interface accessible via web browser


Industry Proven Workflow


Foresight® Codex Up-Version implements a rule-based workflow, where an up-versioning rule is created for for each distinct verbatim/code pair. These rules can be interactively reviewed, approved or overridden, based on user access roles and then applied in batch to the Argus database.
  • Automated analysis of coded terms generates up-versioning rules
    • Unchanged MedDRA term rules are automatically approved
    • Changed MedDRA term rules are flagged for review
  • Manual review and coding/override of rules
  • Up-Versioning session level approvals via e-signatures
  • Comprehensive reports provide decision support, including display of where each verbatim/code pair appears in Argus
  • Batch application of dictionary up-versioning based on approved decisions


Comprehensive Reporting


Built-in reports provide detailed information at each step of the up- versioning process.
  • Up-versioning decision support
    • Comprehensive on screen display of all recoding rules
    • Interactive reporting on where terms are used in the Argus Safety database
    • Comparison of event term and data sheet coding to identify mis-matches
    • Summary reports of all rules by status for offline review
  • Pharmacovigilance reporting
    • Distinct preferred term usage report
    • Summary reports of all Adverse  Event PT changes across database or by product
  • Audit Trail
    • Fully integrated with Argus Safety audit trail for case and configuration data
    • Full auditing of Foresight® Codex Up-Version configuration, manual coding, and review/approval process supports 21 CFR 11 compliance