For medical device, pharmaceutical, and other companies doing business in regulatory environments, compliance with the FDA’s Current Good Manufacturing Practices—or cGMP—often seems like a never-ending, costly, and time-consuming nightmare. In actuality, though, failing to comply with FDA cGMP guidelines is even more expensive and painful than conforming to them. Though they may feel at times as if they are causing undue strain on a company, FDA cGMP requirements are not meant to be a burden; simply put, they exist to ensure that the company’s products are always manufactured in a controlled environment according to quality standards that guarantee consistency. For more than two decades, MasterControl has provided companies with matchless quality management software solutions that allow them to sustain compliance with FDA cGMP requirements and thrive in stringently regulated markets.
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As in any competition, businesses competing in a regulated world can’t win the game if they don’t play by the rules. So how do you comply with the rules of the game without sacrificing efficiency? First, you have to know the rules. For companies regulated by the FDA, that means having a thorough knowledge of FDA cGMP. Second, you need to have in place a system that functions according to the rules. In the FDA regulated game, that means having a quality management system (QMS) expressly designed according to FDA cGMP guidelines. And if that system is automated, you stand an even greater chance of winning against less efficient competitors.
MasterControl provides software applications that have been specifically engineered to facilitate compliance with the FDA cGMP guidelines. The core integrated and easy-to-use MasterControl applications include:
These are just a few of the integrated applications that comprise the MasterControl quality management solution suite that facilitates companies’ compliance with the FDA cGMP. Additional modules are available to help customers with quality management needs that may be specific to their organization. In fact, MasterControl’s All Access solution package is a scalable offering that allows companies to use the quality management tools they need, exactly when they need them. It is a comprehensive offering that is designed to work as a single, integrated solution rather than a combination of components from a variety of companies. All Access puts the ultimate set of professional tools at your fingertips as your business grows and adapts to regulatory and market challenges.
MasterControl software solutions have been designed and modified over the years specifically to help companies doing business in regulatory environments meet requirements like FDA cGMP. Individual modules of the integrated MasterControl solution—all of which are central components of MasterControl’s All Access offering—include:
For more information about FDA cGMP or our software that ensures GLP or GCP compliance-- please feel free to contact a MasterControl representative.