2 Day Virtual Computer System Validation (CSV) Training Course: COTS, SaaS, IaaS, and PaaS Models with Best Practices for Validation, 21 CFR Part 11, and Data Integrity (Nov ...

Market opportunities lie in integrating modern technology and agile methodologies to enhance compliance with FDA regulations. Emphasis on cloud services, validation approaches, and maintaining data ...
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and Radiological Health (CDRH) and the Center for Biologics Evaluation and Research (CBER) jointly released a new draft guidance document titled “Computer ...
FiercePharma

Worried About Computer Software Assurance? Relax, You're Probably Already Doing It

Computer software assurance (CSA), the FDA's new framework for computer system validation (CSV), is being heralded as a game-changer. While the promise of simplified, less costly validation is ...
Labroots

Microbial testing for the pharmaceutical industry: A straightforward path toward regulatory compliance, data integrity, and computer systems validation

Microbial testing, analysis and environmental monitoring is fundamental to safe pharmaceutical manufacturing. Regulatory agencies require that the many components of the system implemented, from ...