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Medical device industry news and trends - and the resources to understand and act on them.

 

Process Validation Case Study: Know What You Know... and What You Don't

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About R&Q case studies: We hope this process validation case study helps you understand how we serve our medical device clients in this area. If you have specific process validation questions please contact us and we'll be happy to help. Looking to solve a different problem? Here are all of our available case studies. Subscribing to our blog is the best way to know when future case studies are available.


Challenge

Transfer troubles.

A company executed site transfer and design transfer together for a newly developed product without an in-depth understanding of the product and its manufacturing process. The lack of detailed product specifications, in-depth process design, and full process validation left the program team searching for a baseline to deem the product as acceptable once the design and equipment was transferred to its new location. The result? The program experienced setbacks in implementation and found itself handling a larger-than-ideal number of nonconforming lots.

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