Tag: Software Validation

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Software validation vs verification in GMP computerized systems with lifecycle and compliance focus

Software Validation vs Verification in GMP

Software validation vs verification explained under EU GMP Annex 11, FDA 21 CFR Part 11, and GAMP 5, with practical...
Software Validation in GMP featured image with digital binary code and compliance theme.

Continuous Software Validation in GMP: Risk-Based Control Across the Lifecycle

Explore risk-based software validation in GMP, from CSV to continuous assurance, ensuring compliance, data integrity, and efficiency....
FDA New Guidance on CSA in 2025 - Featured Image

FDA’s 2025 Guidance on CSA: What Manufacturers Need to Know

FDA’s 2025 CSA guidance introduces a risk-based approach to software assurance, reducing burden and aligning with ISO 13485:2016 compliance....

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