Safety Data Configuration for Regulatory Success.
Your business needs a pharmacovigilance system that grows with you. We deliver validated, 21 CFR Part 11/Annex 11-compliant Argus Safety configurations using proven methods that turn compliance challenges into operational strengths.
Regulatory inspections require readiness and expertise. Our team provides complete support, ensuring your organization stays confident throughout any regulatory review.
Fast, accurate safety decisions drive success. We create intuitive workflows and smart reporting that speed up pre- and post-marketing evaluations, helping your team act quickly on safety insights while maintaining data integrity and compliance standards.
Well-managed systems deliver enhanced capabilities:
- Automated case narrative generation, correspondence creation and data requests that maintain consistency while minimizing errors
- Case classification protocols for identifying high-priority safety events
- Tailored E2B profile configuration, system architecture and validation controls that meet regulatory standards
- Automated global expedited reporting processes that eliminate manual workflows
- 21 CFR Part 11/Annex 11-compliant change management, including automated configuration specification (CS) updates
- Regulatory audit preparation and system validation support
- Specialized support desk providing fast response and issue resolution from team members with both technical and drug safety operational expertise