Quality By Design Technology Intervention
Our client is a medical device manufacturer in Europe with a product that will be getting into clinical development stage soon. Their product is designed to address some challenges within the respiratory disease space. Their products are inspired by the passion to provide life-changing experience for patients suffering chronically.
The challenge
The client was looking for a quality by design implementation before they go into the clinical development stage for their product; quality-control solution that builds quality into production processes rather than testing failures out. They needed a system to increase efficiency with real-time data analysis to help them move past the paper-based reporting system they had previously relied on.
The clients primary objectives were to:
- Reduce reliance on manual systems and paper-based records
- Proactively manage operations efficiency
- Better quality reporting
The Solution
To achieve their process improvement goals, RiverArk worked along with the senior management team to come up with a quality by design concept that would work in their manufacturing domain. Implement it at their Contract manufacturing service provider and follow through.
Our experts helped identify applications for Process Controls, select the best fit, help qualify and validate the system and operationalise it.
We helped the client with models and tools that could be used of the application to provide automated real-time visual analysis of quality data. This helped them address the access to data which was a challenge in their previous manual and not so controlled electronic environment. Such data was useful for the clients Quality team to perform analysis and provide interventions at the right time.
- Identifying deviations and acting upon them quickly
- Use the capabilities within the application and the tools provided to make informed decisions
- Robust reporting capabilities allow quality managers to analyse production quality in real time.
- Visualisation of data by accessing multiple data points and providing graphical representations out of the software suite
The Results
The Quality by design implementation with use of technology now helps the client ensure that every unit is produced to the same exacting standard. All deviations are picked up automatically by the application controls introduced. The operations team at the CMO were able to ensure good reporting cycle times. This in turn ensures that the client in turn provides medical devices that are of high quality and no defects every time.
The clients quality unit can now review current data real-time compare it with all available historical quality records and analyse.
The capabilities the application provides along side the tools and controls that have been set in help provide analysis that is meaningful and useful.