这个发现让我既意外又释然。意外的是，被行业奉为“红线”的CSV验证，竟从未成为FDA的直接处罚靶点；释然的是，这恰好印证了我多年的判断：CSV更多是行业内人为制造的焦虑，脱离这种束缚，才能真正发挥电子实验记录本（ELN）的价值——而这，恰恰契合FDA ...

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 ...

Every time software that pharma, medical device and biotech companies use for development and manufacturing gets updated, the FDA requires it to be validated for data integrity, reliability, and ...

Market opportunities arise in providing solutions for cGMP software verification and validation, addressing increased FDA scrutiny. Demand exists for expertise in FDA guidelines, risk management ...

On January 7, 2025, FDA published a draft guidance titled “Artificial Intelligence-Enabled Device Software Functions: Lifecycle Management and Marketing Submission Recommendations.” The draft guidance ...