“Many medical device and life sciences companies are still carrying out manual validation processes, using paper-based scripts, screen shots and pdfs. However, regulatory bodies, such as the FDA, are encouraging companies to take a more automated approach using computer system assurance (CSA). We are in a strong position to support companies in achieving the huge benefits this has to offer.”
Growing pressure on the manufacturing industry from rising prices, new regulations and supply chain uncertainty have accelerated medtech’s digital transformation. COVID-19, in particular, has encouraged medical manufacturers to adopt more resilient and agile working practices. New technology can enable process changes and business strategies that help medical manufacturers become more flexible and responsive to changing…
In this new survey, medtech manufacturers are invited to share their perspective on business initiatives, manufacturing execution systems and latest challenges.
Automating validation processes gives manufacturers the flexibility and capability to make changes, updates and re-validation, making it easier to upgrade or add new MES modules to their process. Simplifying the process through automation leads to faster ROI and time to market.
With digitalization impacting all areas of manufacturing operations, it should come as no surprise that medical device producers must adapt or risk missing the next wave of performance and product improvements.
How manufacturing execution systems not only help with audits but also aid in production efficiency and faster product introduction.
Manufacturers that make custom devices must move beyond conventional engineering practices to an automated and collaborative engineer-to-order process.
With the advances in technology, FDA has higher expectations from manufacturers as data is more readily available. The integration of other technologies into a comprehensive MES system will drive costs down and quality up.