The Dutch authority carrying out GMP inspections, the Health and Youth Care Inspectorate (IGJ), announced it will carry out a series of ...

ValGenesis, Inc., the global leader in enterprise digital validation and compliance solutions, today announced that GAMP Services Private Limited, a technology and consulting firm based in India, has ...

In pharmaceutical manufacturing, software validation is innovation’s silent killer. A single user requirements specification (URS) takes weeks. Test plans stretch for months. Change controls bog down ...

Cell and gene therapies (CGTs) are shaping modern medicine by targeting diseases at their source through cellular and genetic modifications. The true game-changer for such therapies will lie in ...

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等法规制定者保障药品质量的初心。

A new study from researchers at Wake Forest University School of Medicine shows an improvement in screening rates for anxiety and depression among epilepsy patients with the implementation of an ...

The defense contractor L3Harris Technologies is reinforcing its role in critical munitions supply chains through a significant contract extension and a key regulatory achievement in its space ...

Abstract: A new and effective educational management system has been designed and implemented. Different courses of registered students are considered for the License Master Doctorate (LMD) system.

OSAKA, Japan, Dec. 4, 2025 /PRNewswire/ -- HiroPharmaConsulting (R) Co., Ltd. announced that it has received a patent for an innovative Good Pharmacovigilance Practice (GVP) Computerized System ...

The patented technology, known as the AI-PV HiroPharma Validation Method (AI-PV HPVM), provides a structured and rational methodology to ensure the reliability and regulatory compliance of AI-enabled ...