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 ...

This training unlocks opportunities for companies to modernize GxP validation by shifting to Computer Software Assurance, ensuring data integrity and compliance with FDA regulations, and addressing ...

This course offers a strategic edge by refining cloud system classification through CSA principles, preventing compliance pitfalls and inefficiencies. It empowers teams to enhance validation precision ...

Nia Therapeutics announced publication in Brain Stimulation of the first in vivo validation of its Smart Neurostimulation System (SNS), a wireless, implantable brain-computer interface designed for ...

Continuous compliance: Rather than preparing for audits, agents continuously monitor validation completeness, test coverage, ...

Embrace Computer Software Assurance (CSA) for modern life-sciences by focusing on meaningful evidence rather than burdensome documentation. This approach enhances efficiency, aligns with FDA ...

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

PMI’s FDA-approved SynCardia STAH is promising, but adoption and revenues lag; cash burn and dilution weigh. Read the full ...

After claiming its approval in Europe earlier this year, Abbott has secured the FDA’s go-ahead for its Volt pulsed field ablation system for irregular heart rhythms, a step forward in an international ...

This course offers an essential opportunity to enhance data integrity and compliance for cloud systems. It provides a practical model for documentation and change control, crucial for meeting ...

Edge platforms, which provide a liaison between networks and legacy equipment, can provide a layer of cybersecurity protection without infrastructure modifications ...

ST. PAUL, Minn.--(BUSINESS WIRE)--Cardiovascular Systems, Inc. (CSI ®) (NASDAQ: CSII), a medical device company developing and commercializing innovative interventional treatment systems for patients ...