Articles tagged with “software-validation”

IEC 62304 vs FDA CSA: A Medical Software Compliance Guide

Compare the IEC 62304 standard vs. FDA CSA guidance for medical software. Learn key differences in scope, risk classification, validation, and documentation.

35 min read

12/28/2025

iec 62304 fda csa medical device software software validation 21 cfr 820 qms software regulatory compliance iso 13485

FDA CSA Guidance: A Pharma & Biotech Compliance Guide

Understand the FDA's final Computer Software Assurance (CSA) guidance, a risk-based shift from CSV for pharma & biotech. Learn key principles for compliance.

30 min read

12/27/2025

computer software assurance fda guidance software validation gxp compliance risk-based validation pharma manufacturing 21 cfr part 11

GAMP 5 Categories Explained: Software, Risk & Examples

Learn the GAMP 5 software categories for computerized system validation. This guide explains each category with examples and its role in a risk-based approach.

25 min read

10/16/2025

gamp 5 computer system validation gxp risk-based approach ispe software validation pharmaceutical compliance