The FDA Case for Quality highlights the need for Systems Capability Maturity. Mature systems requires moving from using standalone systems to a system using a common platform with closed loop data sharing. Seabrook build this capability on Siemens Teamcenter PLM, a platform that has the capacity to manage all product and quality related data and share this data across the entire enterprise, the supply chain and if required with customers or partners. This is smart manufacturing, or Industry 4.0 for Medical Device manufacturers.
The webinar associated with this blog post focuses on paperless manufacturing. Everything revolves around quality – the impact on quality, a business case, the impact on operations and what results can one expect to achieve?
The FDA 2015 Quality Subsystem observations identify a high level breakdown of the source of quality issues experienced by medical device manufacturers. Taking a look at the recent FDA figures on Non-Compliance Observations, it is clear that production and process controls are a key source of issues. In our experience, over 50% of non conformances are a result of errors on paper, rather than problems with the product.
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