Pragmatism Over Paperwork: Common Sense in FDA CSA Guidance
It has been almost three decades since the U.S. Food and Drug Administration (FDA) enacted 21 CFR Part 11. Over those years, software validation in life sciences has become a dreaded ritual of producing mountains of paper to appease auditors. However, validation deserves greater recognition as a revolutionary safety mechanism.
To redeem validation as a system of vital guardrails, enter the FDA’s final guidance on computer software assurance (CSA). It officially steers the industry away from compliance theater, known as traditional computer system validation, or CSV, and toward a risk-based, pragmatic framework.
Read More
