Managing all the documentation for the many devices Northeast Scientific remanufactured was complex and prone to errors. A modern manufacturing execution system allowed them to manage documentation by eliminating paper.
Molecular diagnostics is increasingly used for the rapid detection and identification of existing and emerging pathogens. The need for rapid results has required testing to move from normal settings, such as physician’s offices, to smaller, more widespread, and often temporary point of care (POC) locations.
Product quality is a top priority in any business because nothing else matters without it. Measuring the impact of quality instantly becomes the No. 1 business imperative when those process inefficiencies begin to negatively affect the bottom line. See how these companies digitized and connected their document management processes to help accelerate the time it takes to get a product to market without jeopardizing regulatory compliance.
For contract development, manufacturing, and packaging organizations, improving operational flexibility, increasing capacity, shortening lead times, and improving product quality is more important than ever.
Not every QMS has the same capabilities and connectivity. A QMS that isn’t connected to other areas of the enterprise still slows down quality processes and introduces the possibility of more human error.
Your document control system should be agile and scalable to keep up with the changing regulatory landscape. Here, we detail the guidelines and standards that apply, and illustrate how digitizing document control processes is essential for ongoing compliance.
Modern pharmaceutical regulatory and manufacturing models have made great advances assuring and confirming quality of products for all of us. The further industry moves from the initial application of the early practices and subsequent systems, the more challenging it has become to differentiate between the many facets of quality concepts. The intent of this white paper is to clarify those concepts and bring their fundamentals into focus.
It is safe to assume that no organization that intends to stay in business sets out to manufacture or provide a low-quality product. This is particularly true for highly regulated companies. And yet switching from a manual quality management system (QMS) to an electronic one in order to improve product quality and ensure regulatory compliance remains low in most companies’ list of priorities. In this white paper we discuss the most common “quality pains” I’ve seen among regulated companies and offer some strategies on choosing and executing an eQMS.