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The requirements of Life Sciences companies (including in the pharma and medical device space) inevitably change over time. Sometimes, a change is due to regulatory requirements; sometimes, customer needs change. Keep reading if you want to...

Today, the Quality conversation is no longer about making the digital leap from an outdated paper-based Quality Management System (a traditional QMS) to managing your Quality processes with electronic Quality Management software (an eQMS).  That tran...

Implementing a Quality Management System is key to ensuring consistency in all your processes and, ultimately, guaranteeing your product quality and safety.  A well-established QMS will allow you to meet both customer and organizational requirements,...

CSV and CSA both play the same role in the digitally matured life sciences companies. Yet, these approaches have some key differences. In this article, we will review the differences between CSV and CSA. Until very recently, CSA was seen as a futuris...

Healthcare faces complex challenges in a world that is becoming more digital day-to-day. It has become clear that healthcare companies will need to embrace open systems that allow for the sophisticated analysis of multiple data streams and the develo...

Nobody knows the importance of 'Quality Records Management' better than a quality assurance professional! Quality records are invariably scrutinized in every internal or external audit. These documents are treated as living evidence of organizational...

Companies in the life sciences continuously strive to adapt to new developments in our rapidly evolving modern world. Professionals in businesses like pharma, medical devices, and biotech know that in this digital age organizing processes and going p...