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 ...
Yahoo Finance

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

CARY, N.C., Dec. 16, 2025 /PRNewswire/ -- InstantGMP™, a provider of cloud-based GMP and FDA compliance software for pharmaceutical and other regulated manufacturers, announced it has aligned its ...
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FDA inks long-awaited computer software assurance draft guidance

The U.S. FDA released a draft guidance for computer software assurance, a document that spells out the agency’s expectations for computer systems used to log a manufacturing site’s compliance and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

Instantgmp Modernizes Software Validation With FDA Computer Software Assurance-Aligned Approach

(MENAFN- EIN Presswire) EINPresswire/ -- InstantGMPTM, a provider of cloud-based GMP and FDA compliance software for pharmaceutical and other regulated manufacturers, announced it has aligned its ...
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After years of dialogue between the U.S. FDA and industry, the agency’s long-awaited draft guidance for computer software assurance (CSA) for manufacturing facilities signaled a new, less cumbersome ...