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 ...
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FDA inks long-awaited computer software assurance draft guidance

The U.S. FDA released a draft guidance for computer software assurance, a document that spells out the agency’s expectations for computer systems used to log a manufacturing site’s compliance and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

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

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After years of dialogue between the U.S. FDA and industry, the agency’s long-awaited draft guidance for computer software assurance (CSA) for manufacturing facilities signaled a new, less cumbersome ...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