Articles tagged with “csv”

GAMP 5 Second Edition: A Guide to Key Changes & Updates

Learn the key updates in ISPE GAMP 5 Second Edition. Our guide covers the new focus on critical thinking, agile validation, cloud services, and CSA for GxP syst

25 min read

10/10/2025

gamp 5 second edition computer systems validation csv gxp compliance ispe agile validation computer software assurance data integrity

Understanding GAMP 5 Guidelines for System Validation

An overview of GAMP 5 guidelines for validating computerized systems. Explains the risk-based approach, system lifecycle, and updates for AI and cloud tech.

20 min read

9/12/2025

gamp 5 csv pharmaceutical manufacturing ispe risk-based approach regulatory compliance system lifecycle artificial intelligence

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

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