Biocare Medical Digitalizes Drug Approval Quality Assurance
High costs as well as high risks to health: Quality assurance is one of the most critical processes during the approval of a drug. Consequently, Biocare Medical, which develops and manufactures automated immunohistochemistry instruments and reagents for IHC laboratory tests, is no exception. As part of a comprehensive project, the company is therefore digitizing the entire quality assurance process, relying on a joint solution from Axon Ivy and InnoVelocity Inc. In addition to quality assurance, Biocare Medical also automates Covid-19 workforce management.
Reduced Time, Improved Efficiency
Forty-nine hours - that's how much time was previously spent on data analysis and reporting alone as part of Biocare Medical's comprehensive quality assurance process. Based on Axon Ivy's technology, InnoVelocity Inc. developed a solution as part of a comprehensive digitization strategy that reduces this time to just four hours, shortening the company's entire medical device certification process. As a result, data control and reporting efficiency were improved by 90 percent and all ISO/MDSAP certification requirements were met.
Axon Ivy as the Central Platform
"This project was instrumental to Biocare's growth and success for two reasons: first, it transformed critical business knowledge into repeatable business logic, and second, it significantly reduced the time required to train and build additional resources," said Morgan Porter, COO of Biocare Medical.
As a first step, managers used BPMN to document the process, which until then had been largely manual. The result: standardized workflows and the definition of a consistent process flow. On this basis, the second step was to automate manual tasks such as scanning and forwarding documents and checking data. This leads to a reduced susceptibility to errors throughout the entire process.
All relevant documents, responsibilities, and deadlines are now bundled and transparently available on one platform. Stored business rules and escalation levels ensure a smooth and rule-compliant process. The current status of a product can be called up at any time, and reports generated on demand. This enables continuous digital control and monitoring of the quality assurance process.
Independent Adjustments Using Low-Code
Thanks to the low-code support of the Axon Ivy platform, Biocare Medical can make adjustments to the process independently and without IT support or time-consuming training. Axon Ivy can be seamlessly integrated into existing systems and operated intuitively. Simultaneously, the platform offers excellent technical depth, which means that even complex processes can be mapped and be used flexibly for a wide range of business processes.
“Thanks to the low-code support of the Axon Ivy platform, Biocare Medical can make adjustments to the process independently and without IT support or time-consuming training.”
Tim Harris
Director Americas Sales and Business Development, Axon Ivy Inc.
Digital Workforce Management for Safe Work
In addition to quality assurance, Biocare Medical is also automating Covid-19 workforce management. In the future, employees can be divided into shifts or to different premises via the management system in a simple and user-friendly way, so that they work in the spirit of social distancing. With the help of integrated Covid checklists that can be filled out daily and can also be accessed on mobile devices, symptoms of illness can be checked even before employees start work. Reports can be generated at any time for management or authorities based on employee planning and sickness reports received, making it easier to track cases of illness in a timely manner.
Innovation, Growth, and Success
Biocare Medical has taken an important step on the road to digital transformation with the digitization of the quality control process. Thanks to the scalability of the platform, the company is well positioned to meet future digitization and automation requirements and to implement them quickly and easily. This allows Biocare to position itself as an innovative company and nothing gets in the way of further growth and success.