Hugel Pharma, a global biotechnology firm, had a few approved products that were ready for marketing. The organization, however,did not have a safety system in place. They were looking for a partnerthat could deliver a safety system in a timely manner.
Hugel had products that were ready for market and needed a drug safety solution in place. The knowledge of the team with respect to the process for implementing a safety systems was inadequate. They were banking on a partner that could deliver a fully validated system accompanied by project management. The key challenges faced by Hugel were:
- A limited understanding of safety system implementation
- Having a fully validated safety system ready in time to market the drugs
- End-user training for the system was required
Techsol and Hugel worked together to deliver a system that met the business requirements through seamless project management.
- Implementation of Argus Safety v7.0.4.1 on Oracle Cloud was expedited following Oracle’s delivery of the Argus licenses.
- The entire system was validated by Techsol to ensure compliance with regulatory rules and guidelines.
- End-user training was provided to ensure the Hugel team was able to work with the new system effectively.
- Post-implementation ‘hypercare’ (24X7 support) by Techsol made sure that issues were resolved with minimum downtime.
Hugel gained many benefits through the efficient implementation of the drug safety system:
- A timely delivery of the drug safety system
- Fully validated system as per GAMP 5 guidelines
- A 50% reduction in human effort for case processing
- A system for end-to-end case processing meeting regulatory compliance requirements
- Compliance audit readiness through the control and recording of all pharmacovigilance and case processing activities