Nonconformance is one of the leading reasons for medical device manufacturers receiving FDA warning letters. Regulation 21 CFR 820.90(a) establishes the FDA requirement that manufacturers must establish and maintain procedures to minimize nonconformance to specified requirements.
Often, the high incidence of nonconformance is caused by the inability of design and development teams to trace the root cause (of what causes the deviation). In several cases, the primary reason traceability becomes difficult because product design and related documentation are managed using tools like Microsoft Word, Excel spreadsheets, emails, etc.
In the spreadsheets, users can create a formula that automates calculations required for developing a product. But version control can be a challenge. This problem can be overcome by using a next-generation PLM software that integrates a quality management system
With a next-gen PLM solution, in addition to automating this process, monotonous and manual tasks and elements can be removed, freeing up resources to add value. Version control also becomes inherent to the system. In addition to that, a modern PLM solution also enables the creation and management of the Design History File (DHF), one of the most complex and multifaceted elements that go into design & development.
This approach of automating and digitally transforming the PLM lifecycle will certainly shorten the development time - while also enabling faster time-to-market and better quality.
In this whitepaper, we will explore:
- The globalization of product development process
- How to improve visibility into processes & better change control
- Automation of PLM processes
- PLM workflow automation with ComplianceQuest
- And more