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Posts Tagged ‘fda’

Medical Device Manufacturers Can Streamline UDI Management

The medical device manufacturing industry is highly competitive and highly regulated. Manufacturing high-quality, life-saving products requires strict oversight of all aspects of production—from inventory to manufacturing and distribution to the end user. The Food and Drug Administration (FDA) has established a unique device identification (UDI) system to track medical devices with the end goals to […]

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ERP Software Compliance for Regulatory Standards such as SOX, FDA, and ISO using Microsoft Dynamics NAV

Let’s face it, whether you’re a publicly or privately held company today, it’s quite likely that you will need to comply with at least one regulatory agency in order to meet your customers’ needs. Whether it’s ISO, FDA, SOX (Sarbanes Oxley), DOD, etc., you need a system that is robust enough to provide the necessary […]

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Is Food, Cosmetic, and Drug Manufacturing Software FDA Approved?

I have been asked many times over the years if manufacturing or ERP software was FDA approved.   Based on my experience in the manufacturing industry, ERP software is not FDA approved, but rather can be utilized to follow and maintain your company’s processes to be compliant with the Current Good Manufacturing Practice (CGMP). If you […]

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