Articles tagged with “computer-system-validation”

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

21 CFR Part 11: IT Guide to Electronic Records & Signatures

A detailed guide for IT on 21 CFR Part 11. Learn the FDA's rules for electronic records & signatures, including system validation, audit trails, & data integrit

45 min read

10/12/2025

21 cfr part 11 data integrity fda regulations electronic records electronic signatures computer system validation annex 11 audit trails

Understanding the 2025 Job Market for CSV Professionals

Learn about the 2025 job market for Computer System Validation (CSV) professionals. Understand CSV's critical role in regulated industries for data integrity and patient safety.

15 min read

6/23/2025

computer system validation csv job market analysis career outlook regulated industries data integrity regulatory compliance fda 21 cfr part 11 quality assurance

GAMP 5: Computerized System Validation in Pharma

This guide explains GAMP 5, its principles, and lifecycle for computerized system validation in pharma, covering regulatory compliance and real-world applications.

25 min read

5/31/2025

gamp 5 computer system validation pharmaceuticals regulatory compliance fda 21 cfr part 11 eu annex 11 ispe automated manufacturing data integrity risk-based approach

Computer System Validation in Pharma & Biotech Compliance

Learn what Computer System Validation (CSV) is, its crucial role in pharmaceutical and biotech compliance, ensuring data integrity and regulatory adherence for patient safety.

55 min read

5/30/2025

computer system validation csv pharmaceutical compliance biotech compliance fda regulations data integrity gxp 21 cfr part 11