April 26, 2013

BKP Codex: Up-Version

Codex Up-Version

BKP Codex: Up-Version 8.1, a MedDRA up-versioning tool from BKP Technologies, Inc. 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. BKP Codex: Up-Version 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.

 

Features – At a GlanceRuleScreen

 

  • Fully integrated with Oracle Argus Safety™ 7.x/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 BKP Codex: Up-Version as a 21 CFR 11, Annex 11 and HIPAA compliant system
  • Friendly web-based user interface accessible via web browser

 

Industry Proven Workflow

BKP 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.

WorkflowScreen

  • 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 supportCodexup Report
  • Pharmacovigilance reporting
    • Distinct preferred term usage report
    • Summary reports of all Adverse  Event PT changes across database or by product
    • Japanese LLT changes report
  • Audit Trail
    • Fully integrated with Argus Safety audit trail for case and configuration data
    • Full auditing of BKP Codex: Up-Version configuration, manual coding, and review/approval process supports 21 CFR 11 and Annex 11 compliance

To learn more about the BKP Codex: Up-Version, download our info sheet or contact us for a free consultation.  The BKP Codex: Up-Version tool is part of the BKP Codex Suite of tools.