Susan J. Schniepp, distinguished fellow at Regulatory Compliance Associates, details regulatory requirements for developing a quality manual. and not just the quality department, similar to how the ...

Quality is a difficulty term to define, but most people know it when they see it. A quality product is made well, with integrity and attention to detail. A quality management system (QMS) is a formal, ...

As AI technology and no-code automation tools continue to evolve, manual testing seems to be losing its edge. This perception may or may not align with reality, as multiple factors are impacting ...

Purpose-built electronic quality management systems are a better fit for CGT production than traditional technologies.

Grace McNally, in the Office of Compliance at FDA's CDER, discusses the role of QbD and pharmaceutical quality systems as it relates to contract manufacturing. The US Food and Drug Administration's ...

At its simplest, manufacturing quality involves conforming to specifications and leveraging design quality to create the highest possible standard. With production workers more reliant on mobile ...