The medical device industry is characterized by cost pressures, competitive markets and complexities associated with global distribution and regulatory compliances mandated by global and regional regulatory bodies (FDA, EMA, TGA, etc.). Failure to comply is a significant risk threatening the organizations’ ability to sell products in the market. Medical device organizations must apply for and maintain licenses or registrations that are subject to approval and renewal with global bodies for each product in that market. Maintaining product registration and licensing becomes a challenge when the organization has a global footprint and extensive product portfolio to manage.
The client was looking for a trusted partner to design and implement a systematic method to provide end to end management of their product licenses and registration. There was a pressing need to devise and implement an efficient and agile method to rationalize data and processes. The system would simplify the process and make it easy for the client to stay compliant with global regulatory mandates.
- Reduce resource load in order to fulfill client orders and go to market with a less resource-intensive business model
- Growing operational complexities in managing data associated with an extensively large product portfolio
- Disconnected source systems, compartmentalized business processes, dynamically changing regional requirements
- Redundancies arising out of inconsistent formats and templates for registration across regions
- Isolated business processes create data and process redundancies which take a toll on overall efficiency and hamper innovation
Birlasoft developed the Global Product Registration (GPR) solution to manage the client's regulatory process in Oracle's Agile Product Lifecycle Management (PLM) application. Birlasoft's GPR solution consolidates all regulatory requirements into a uniform process across the enterprise and enables the systematic tracking of the regulatory requirements by building a seamless integration with the product Lifecycle management process. The platform receives the finished good as an input and generates the submission documentation based on pre-configured templates. The documentation is managed within an Agile workflow and upon approval, submitted to the regulatory bodies. The GPR solution processes the regulatory body's response within Oracle Agile PLM, taking actions based on their feedback and input from workflow owners. Once released, the GPR solution automatically tracks the expiration of registrations and initiates the renewal process for approved Finished Goods.
Birlasoft's GPR solution has consolidated and automated the client's enterprise product registration processes and has eliminated the risks and complexities associated with disparate source systems, manual and geographically unique processes. It simplified the regulatory processes by consolidating product data into single repository and automating the submission, tracking, recording, and expiration of product registration. By automating the arduous global product registration process, the client was able to harness significant benefits in terms of reduced regulatory risks and improved operational efficiency. The GPR solution has provided the ability to leverage where-registered reporting, enabled tracking and notification of all product registrations, and installed a globally accessible repository.