Grit Daily

Risk-Based Innovation: How a Quality Professional Is Elevating Software Assurance

Risk is a lens, not a leash. Once teams see what truly threatens patients and processes, the busywork falls away, and quality ...
JD Supra

FDA’s Draft Computer Software Assurance Guidance Changes the Game for Quality System and Production Software Validation

On September 13, 2022 the Center for Devices and Radiological Health (CDRH) and the Center for Biologics Evaluation and Research (CBER) jointly released a new draft guidance document titled “Computer ...
JD Supra

FDA finalizes computer software assurance guidance for production and quality system software

The U.S. Food and Drug Administration (FDA) recently finalized its guidance document, Computer Software Assurance for Production and Quality System Software, for software used in device production and ...

InstantGMP Modernizes Software Validation with FDA Computer Software Assurance-Aligned Approach

InstantGMP™, a provider of cloud-based GMP and FDA compliance software for pharmaceutical and other regulated manufacturers, announced it has aligned its software development and validation practices ...
Business Wire

ISACA Produces New Audit and Assurance Programs for Data Privacy and Mobile Computing

ROLLING MEADOWS, Ill.--(BUSINESS WIRE)--Global business technology association ISACA has released new audit and assurance programs within the data privacy, mobile computing, Secure Shell Protocol, ...
PharmiWeb

3 Day Virtual Computer System Validation (CSV) Training Course | Streamlined Validation with a Focus on Risk-Based Approaches (Sept 23rd - Sept 25th, 2025) - ResearchAndMarkets.com

DUBLIN--(BUSINESS WIRE)--The "Computer System Validation (CSV) Training Course (Sept 23rd - Sept 25th, 2025)" training has been added to ResearchAndMarkets.com's offering. The attendee will learn ...