GemVax were in need of safety solution as their products are ready to be marketed. They had a limited understanding of the overall process of implementing a safety systems application. The requirement was to manage the entire project to deliver a fully validated system before marketing of the approved products. The key challenges GemVax faced in preparing to marl‹et their approved products:
- Limited understanding of safety system implementation
- Implementing a fully validated safety system in time to market the drugs
- End-user training to work on the newly implemented system
Techsol worked with GemVax to manage the project and ensure delivery of all elements required to meet the business objectives.
- Post-delivery by Oracle, we fast-tracked implementation of Argus Safety v188.8.131.52 on Oracle cloud.
- Our team provided validation for the entire system to mal‹e sure the application was compliant with the regulatory rules/guidelines.
- We provided end-user training to ensure the application was used to its full potential, accurately.
- We provided post-implementation hypercare to GemVaH team ensuring dll their issues were resolved in a timely manner.
Efficient execution of the project brought many favourable results for the client:
- The safety system was ready before the product go-live and on-going study
- Fully validated system as per GAMP5 guidelines
- Reduction in human effort for case processing
- Regulatory compliant system with the ability to perform end-to-end case processing
- Increased audit compliance with more control over all pharmacovigilance activities and recording of all case processing activities