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 ...

VANCOUVER, British Columbia--(BUSINESS WIRE)--Elevated Signals, the manufacturing execution system (MES) for the cannabis industry, today announced it is GMP-ready, following third-party validation ...

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 ...

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 ...

Validation of computerised systems is a regulatory requirement for both GMP and GLP laboratories. Although computerised system validation (CSV) has been required for over 40 years, the approaches ...

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

Mahboubeh Lotfinia works as a Qualified Person and Quality Partner at F. Hoffmann-La Roche and is trained in GMP/GDP audit execution and CSV (Computerized System Validation).

Validated next-generation sequencing soon will become necessary in ensuring the safety and efficacy of cell and gene ...