Compliance

The pharmaceutical and medical technology sectors have long grappled with the complexities of clinical trial management. Traditionally, these processes involved disparate systems and manual workflows, leading to inefficiencies, data silos, and delays. However, the advent of electronic quality

The laboratories of today face numerous challenges that call for heightened efficiency, accuracy, and streamlined workflows, creating a pressing need for reliable automation solutions. Responding to these demands, Tecan has introduced Veya™, a cutting-edge liquid handling platform designed to r

The memorandum to President Trump suggests addressing the significant need for a cohesive strategy to manage biological risks through the establishment of a Unified National Biosafety and Biosecurity Agency. The driving factor behind this proposal is the potential for high-risk laboratory research

Genetic testing for Lynch Syndrome (LS) is crucial in preventing certain cancers, especially for women diagnosed with endometrial (womb) cancer. This inherited condition significantly raises the lifetime risk of various cancers, including bowel, ovarian, pancreatic, and womb cancers. Despite

The US Food and Drug Administration (FDA) raised serious concerns about Sanofi's manufacturing facility in Framingham, Massachusetts, by issuing a Warning Letter for significant deviations from current Good Manufacturing Practice (cGMP) standards for drug substance production. This alarming

Recently, concerns have been raised by Clinical Safety Officers (CSOs) regarding the potential risks to patient safety due to NHS trusts' historical non-compliance with digital clinical safety standards. A BBC investigation revealed that 126 cases of serious harm, including three fatalities,