Tag: CSA

If you don’t find what you are looking for, try using a different term or contact us.

Software Validation in GMP featured image with digital binary code and compliance theme.

Software Validation in GMP: Continuous, 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....

BECOME A GMP INSIDER

Stay in touch and be the first to get the latest GMP News!