BKP Codex: Up-Version 8.3, 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 Glance
- Fully integrated with Oracle Argus Safety™ 8.0-8.2.3
- Supports Argus Multi-Tenant
- 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
- Analysis of coded term changes
- 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.
- Automated analysis of coded terms generates up-versioning rulesUnchanged 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
- 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.