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 ...
Dublin, March 10, 2025 (GLOBE NEWSWIRE) -- The "FDA Trends for Computer System Validation (CSV) Compliance and Enforcement" training has been added to ResearchAndMarkets.com's offering. Upon ...
Dublin, Nov. 10, 2025 (GLOBE NEWSWIRE) -- The "Computer System Validation Training Boot Camp?: Master FDA, EMA, and GAMP 5 Computer System Validation Requirements (Dec 9th - Dec 11th, 2025)" training ...
LIMERICK, Ireland, Oct. 08, 2024 (GLOBE NEWSWIRE) -- kneat.com (KSI:CA), inc. (OTC: KSIOF), a leader in digitizing validation and quality processes, is pleased to announce that a global pharmaceutical ...
In this webinar, you’ll learn about the importance of computer system validation (CSV), how frequently it should be performed, and the benefits it can have to help meet FDA regulations and quality ...
As a “GxP” system, following Good Manufacturing, Laboratory and Clinical Practices, the computer system must be validated in accordance with FDA requirements. If electronic records and/or electronic ...
DUBLIN--(BUSINESS WIRE)--The "Computer System Validation (CSV) Training Course (Sept 23rd - Sept 25th, 2025)" training has been added to ResearchAndMarkets.com's offering. The attendee will learn ...
Dublin, Sept. 10, 2025 (GLOBE NEWSWIRE) -- The "Computer System Validation (CSV) Training Course (Sept 23rd - Sept 25th, 2025)" training has been added to ResearchAndMarkets.com's offering. The ...
The certification that a computer is operating according to specification. It includes the observation of the hardware, software, connected instruments, as well as the practices trained staff employ ...
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