Tag: CSA

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EU GMP Annex 11 versus FDA 21 CFR Part 11 comparison for computerized systems and electronic records

Annex 11 vs 21 CFR Part 11: Comparison and GMP Requirements

Comparison of Annex 11 and 21 CFR Part 11, with practical takeaways on validation, governance, risk management, audit trails, electronic...
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....
CSV vs CSA software validation differences – featured image showing a professional using a laptop with digital icons representing compliance, documentation, and data security.

CSV vs CSA: Key Differences in Software Validation

Discover the key differences between CSV and CSA in pharma, shifting from document-heavy compliance to risk-based assurance...
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....
CSV in pharmaceutical manufacturing - featured image

Computer System Validation (CSV) in the Pharmaceutical Industry

Practical guide to CSV in pharma: lifecycle validation, Annex 11 updates, GAMP 5 methods, CSA approach, and real-world compliance practices....

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