An industry-leading manufacturer of electroporation cell therapy instruments for lab automation was developing a new generation of their instrument product line that would be reliable, easy to use, and visually appealing. However, the client’s development team was struggling to keep up with the development of their automated molecular diagnostic testing system for COVID-19 due to workload, limited resources, limited expertise, and pressure of the pandemic. Gener8’s software division, The RND Group, provided QA professionals with expertise in the development of medical devices and IVD systems to address these challenges. The QA professionals improved processes, provided manpower, developed and verified software, conducted software hazard analysis, implemented a solid verification strategy, and completed comprehensive project documentation to deliver a full set of documentation and source code to the customer.
Challenges
- An instrument line using older technology and requiring significant training to use the software on the existing instrument
- Provide a complete hardware and software overhaul of the multi-instrument product line, while preserving the proprietary electroporation technology that made the product line unique and successful
- Design must be reliable, easy to use, and visually appealing, to pave the way for adoption by many new customers and fuel the customer’s aggressive growth plans
Solutions
- IVD Software Project Documentation
- Assay Management
- Reporting and data exporting/importing
- Consolidated 4 different software source code bases into a single code base that runs on 4 instrument types
- Delivered a full set of documentation and source code for a complete Design History File (DHF)
- Produce 1-2 software releases per year; serving as an extension of the customer’s support organization managing over 1000 instruments in the field
- Developed, verified, and validated to IEC 62304 and 21-CFR Part 11
- Quality Assurance
- Scalable from single researcher to large production environments