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How to Validate Software for the FDA

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To ensure that happens, the FDA regulates life science firms according to regulations specified in 21CFR. Part of that regulation is validation of the software used by life sciences businesses.

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How do quarterly ERP software updates impact FDA Validation

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ERP (Enterprise Resource Planning) software is a critical tool for businesses in many industries, including those that are regulated by the FDA. These software systems are constantly evolving, with new updates and releases being made available on a quarterly basis.

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Why SAP ERP Makes Sense for Pharmaceutical Manufacturing

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Legacy software systems no longer make sense for life sciences businesses, especially those in Pharmaceutical manufacturing. The problem is that complexity, regulation, and competition have changed how pharmaceutical and life sciences firms must do business. Data is siloed, hard to update, and time-consuming to store or use.