On September 13, 2022 the Center for Devices and Radiological Health (CDRH) and the Center for Biologics Evaluation and Research (CBER) jointly released a new draft guidance document titled “Computer ...

BOSTON--(BUSINESS WIRE)--Sware, provider of the most complete software validation solution for innovative life sciences companies, today announced that it raised $6 million in Series B funding, ...

In the highly regulated world of life sciences, quality isn’t a box to check—it’s a business imperative. For global en ...

The U.S. Food and Drug Administration (FDA) recently finalized its guidance document, Computer Software Assurance for Production and Quality System Software, for software used in device production and ...

(MENAFN- GlobeNewsWire - Nasdaq) The main market opportunities include training on modern technologies for computer system validation, compliance with evolving FDA regulations, and risk-based ...

With car companies adding more cameras, digital display screens, active safety systems and other technology to their vehicles with each passing year, they are starting to rely more and more on ...

BioAnalysis launches BASIS 2.0, its next-gen GMP-compliant AUC software for gene therapy. Higher throughput, one-click workflows and full regulatory compliance. We built BASIS 2.0 to dramatically ...

Software in the healthcare industry has come a long way over the past 20 years. Medical device companies, like most life sciences companies, were a bit hesitant to incorporate software and automation ...

Validate it? I just want to use it! Sound familiar? Most companies in the medical device industry understand and accept the need to validate software that is critical to the functioning of a medical ...

Major compliance overhaul: Gilead revamped core validation procedures, shifting to a risk-based approach that reduced redundancy and streamlined approvals. Next-gen systems rollout: A global Quality ...