If you’re using industry-proven best practices in your regulated or non-regulated sector – including ISO 9000, Six Sigma, APQP, CMMI and FDA 21 CFR Part 820, you must be able to demonstrate compliance with extensive failure reporting and corrective action / preventive action standards. When failures or issues are encountered, they must be documented, tracked, analyzed for root cause, and corrected or prevented – not just in current products, but in future ones, as well.
Windchill CAPA enables proven best practices and compliance with a wide range of CAPA standards, including those in industries like Medical Devices that require rigorous closed loop processes to control both internal and external quality issues.
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