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, Nov. 07, 2025 (GLOBE NEWSWIRE) -- The "Computerized Systems Validation, Data Integrity & Cloud Computing In Pharma & Biotech (Dec 9th - Dec 10th, 2025)" training has been added to ...

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 ...

The "Computerized Systems Validation, Data Integrity & Cloud Computing In Pharma & Biotech (Dec 9th - Dec 10th, 2025)" training has been added to ResearchAndMarkets.com's offering. Advancements in ...

(MENAFN- GlobeNewsWire - Nasdaq) Market opportunities lie in modernizing software development and validation approaches, emphasizing agility and continuous validation to meet changing needs, while ...

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 ...

Computerized systems are those which comprise the components shown in Figure 1.1, namely, a computer system and a controlled function which is operating within its specified working environment. The ...

DUBLIN--(BUSINESS WIRE)--Research and Markets(http://www.researchandmarkets.com/research/7989d0/elearning_course) has announced the addition of the "E-Learning Course ...

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 ...