Profile and Challenge: 

The Therapeutic Goods Administration (TGA) was contending with an antiquated, disjointed legacy system that was not conducive to the dynamic landscape of legislative compliance. The transformation needed was multifaceted, requiring not just a system overhaul but a rethinking of how applications forms were managed and how users – including manufacturers, agents, and sponsors – provided submissions to TGA. The goal was to ensure a seamless transition to a structure that would not only comply with existing regulations but also adapt to future legislative changes. 

Solution: 

Teratek’s resources achieved. 

  • Program-Level Architecture: We formulated a program-level architecture that mapped out the trajectory for future capabilities and process modelling. This strategic blueprint was pivotal in envisioning a system that could grow and evolve with TGA’s objectives. 
  • Dynamics 365 Case Management and Dataverse Portal: At the operational level, we helped designed and implemented a Dynamics 365 Case Management system coupled with a Dataverse Portal. This integration allowed for streamlined reporting and efficient management of submissions, tailored to meet the specific compliance mandates of TGA. The system enabled various stakeholders, such as manufacturers, agents, and sponsors, to interact with TGA in a compliant and user-friendly environment. 

Result: 

The implementation of the program-level architecture and the new Dynamics 365 Case Management system yielded the following outcomes: 

  • Enhanced Compliance Management: The system provided a unified platform for managing legislative compliance more effectively, reducing the risk of non-compliance and enabling quicker adaptation to regulatory changes. 
  • Streamlined Submissions Process: Stakeholders experienced a simplified and more intuitive submissions process, improving accuracy and efficiency in reporting. 
  • Operational Efficiency: The consolidation of disparate systems into a single case management system eradicated redundancy, leading to time and cost savings. 
  • User-Centric Design: The Dataverse Portal’s design centred around user experience, which facilitated higher engagement levels from stakeholders and improved the overall quality of data submissions. 
  • Future-Ready Framework: TGA now possesses a scalable architectural framework capable of accommodating future technological advancements and regulatory requirements, ensuring long-term sustainability of the digital ecosystem. 

In conclusion, Teratek’s intervention has provided TGA with a robust and comprehensive solution that not only addresses today’s challenges but also sets a solid foundation for future growth and adaptation. The project stands as a testament to Teratek’s strategic foresight and technical expertise in delivering complex, compliance-driven architectural services.