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Risk-Based CSA Validation: Ensuring the Least Burdensome Approach

Leave a Comment / computer system validation, CSA, Digital Health, Focus Article, least burdensome approach, Medical Device, MedTech, Product Design & Development, Quality/Regulatory, sostware testing, Therac-25, verification / By

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

Leave a Comment / automation, compliance, computer system validation, CSA, Digital Health, Medical Device, MedTech, quality management, Quality/Regulatory, RC - Medical Device Audits, Certification & Verification, Soapbox / By

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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Critical Manufacturing Partners with Dataworks To Enhance CSA Support

Leave a Comment / CSA, Medical Device, MedTech, MES, partnership, Quality/Regulatory, regulatory, validation systems / By

Critical Manufacturing Partners with Dataworks To Enhance CSA Support     Critical Manufacturing, developer of multi-site manufacturing execution systems (MES), has entered into a strategic partnership with Dataworks, a provider of software solutions and validation services for the Life Sciences sector. “Dataworks focuses on the provision of transformational software solutions and validation services within the Life …

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