Author Archives: Martin Lipa

Building a Solid Foundation for a Pharmaceutical Quality System: Presenting QRM and KM As United Enablers

Risk, knowledge, uncertainty, decision-making: They are among the building blocks at the center of the biopharmaceutical industry that guide the daily operations of biopharmaceutical organizations, from the work of scientists during discovery to technicians manufacturing each batch. Indeed, the biopharmaceutical industry is a knowledge-based industry in which organizations satisfy patient needs while gaining competitive advantage by their ability to grow, transfer, and apply knowledge rapidly and effectively. Many people who read the word knowledge have a certain implicit interpretation of…