Medical Innovation Exchange

computer system validation

Join J&J, Pfizer and FDA at the Supply Chain Summit and Advanced Manufacturing Conference

Join J&J, Pfizer and FDA at the Supply Chain Summit and Advanced Manufacturing Conference     Supply chain challenges and the move to advanced manufacturing are two key issues affecting the Medtech industry. On November 7-9, MedTech Intelligence will be hosting the MedTech Advanced Manufacturing Conference and Supply Chain Summit, in partnership with Axendia, Inc. The …

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Join J&J, Pfizer and FDA at the Supply Chain Summit and Advanced Manufacturing Conference

Join J&J, Pfizer and FDA at the Supply Chain Summit and Advanced Manufacturing Conference     Supply chain challenges and the move to advanced manufacturing are two key issues affecting the Medtech industry. On November 7-9, MedTech Intelligence will be hosting the MedTech Advanced Manufacturing Conference and Supply Chain Summit, in partnership with Axendia, Inc. The …

Join J&J, Pfizer and FDA at the Supply Chain Summit and Advanced Manufacturing Conference Read More »

Risk-Based CSA Validation: Ensuring the Least Burdensome Approach

Risk-Based CSA Validation: Ensuring the Least Burdensome Approach     Now that the FDA guidance on computer software assurance (CSA) is available, life sciences companies that have struggled with traditional computer system validation (CSV) are eager to adopt it, and it’s easy to understand why. The modernized framework is designed to help manufacturers achieve CSV more …

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Automating Computer Systems Validation for Your QMS

Automating Computer Systems Validation for Your QMS      Companies must show that their software systems are performing as expected to comply with regulatory requirements. All validation activities and test results must be documented to define both how the software is used and what the user needs to do with it. By using this documentation, we …

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