Streamlining the Regulatory Process
To maintain regulatory compliance while meeting product delivery deadlines, a pharmaceutical laboratory needed secure visibility and data access across multiple departments and functions throughout the organization.
Drug Enforcement Administration (DEA) approval requires annual reports on drug registrations, permit processes, losses and thefts, and other data on pharmaceutical products. This data is maintained in a variety of different systems managed by multiple stakeholders throughout the organization. Collecting, collating, and validating this information for DEA reports requires orchestration across these systems and stakeholders.
Tresbu Digital determined that the best solution was automating the manual workflows for coordinating all activities related to the regulatory approval process. Our new Mendix application, automated the formerly manual process, reducing time and errors, and implementing transparent tracking and alerting for all DEA-related activities from start to finish. This app easily links to SAP for seamless collection of DEA Transaction IDs and other data for timely reporting to the DEA. The client can also update and adapt the platform as needed for future solutions.
The laboratory saved 8-10 hours of labor each week. It lowers regulatory management costs by 16%. The system increased security and risk management while increasing visibility and control in the approval process, resulting in timely submissions and more efficient compliance.