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The medical device industry is challenged by the need to maintain compliance with FDA regulations along with high pressure to increase yields and reduce time-to-market. Implementation of eDHR, CAPA, deviations management, ECM, and manufacturing intelligence certainly help fulfill important requirements. IT system needs to follow 21 CFR Part 11 requirements. Our award winning iPQM solution is tailored to enable collaboration between engineering and manufacturing, and to detect quality issues proactively and quickly to effectively complete CAPA and ECM processes. We have partnered with CamStar* to provide various services for medical device industry.
*Camstar is a provider of enterprise manufacturing execution and quality systems (MES). Camstar provides manufacturing solutions in the areas like medical devices, semi-conductors and biotech. |
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