MASTERCONTROL, INC.

Data Sheet Data Sheet If your company is planning to convert to an automated system for managing documents and business processes, make sure...

Paper doesn’t just slow down manufacturing, it also keeps manufacturers from fully using their data. A digital system that’s connected to other...

Device Classifications One of the biggest changes from the in vitro diagnostic directives (IVDD) to IVDR is the move from list-based IVD device...

A product's quality, reliability and safety depend to a great extent on its conformance to specifications that have been tested, proven safe and...

Supply chains can become extensive and involve multiple levels of suppliers, depending on the complexity of the end product. Managing various...

It seems that Quality by Test is well on its way to being a thing of the past, and for good reason. One out of every 10 drug products make it to...

The velocity of innovation and competition in the life sciences is relentless. It’s prompting an increasing number of companies to adopt...

For a medical device manufacturer, one of the most challenging aspects of compliance is understanding whether a manufacturing process must be...

The prospect of an inspection by the U.S. Food and Drug Administration (FDA) causes dread for many manufacturers. If gone poorly, an FDA audit...

Required Functions of a QMS A quality system needs to include tools, processes and resources that enable a company to fulfill quality management...