FDA 新指南落地：以风险为核心，规范医疗器械生产与质量系统软件保证

2025年9月24日，美国食品药品监督管理局 (FDA)正式发布了Computer Software Assurance for Production and Quality System ...
JD Supra

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

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and Radiological Health (CDRH) and the Center for Biologics Evaluation and Research (CBER) jointly released a new draft guidance document titled “Computer ...

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 ...
BioWorld

FDA inks long-awaited computer software assurance draft guidance

The U.S. FDA released a draft guidance for computer software assurance, a document that spells out the agency’s expectations for computer systems used to log a manufacturing site’s compliance and ...
BioWorld

Ambiguity a sticking point for industry in FDA’s computer software assurance draft

After years of dialogue between the U.S. FDA and industry, the agency’s long-awaited draft guidance for computer software assurance (CSA) for manufacturing facilities signaled a new, less cumbersome ...
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 ...
Healthcare Dive

FDA 2022's A-list guidance plan hits on software, post-pandemic future

FDA divides its planned guidelines into an A-list featuring prioritized documents and a B-list of texts it intends to publish. This year, the A-list is topped by the final guidance on clinical ...