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

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

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 ...

BioPharma Consulting Group today announced the launch of a new digital transformation advisory framework designed to ...

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

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 ...

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 ...

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 ...

The topic of AI and its implications for orthopedic surgeons became of high personal importance when Bill Gates predicted that AI would replace physicians and others within the next decade. As an ...

In the 1999 sci-fi classic The Matrix, “plugging in” symbolized digital enslavement. In 2025, for a paraplegia patient in ...

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 ...