FDA cGMP


Managing FDA cGMP Requirements with Quality Management Solutions

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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FDA cGMP: Playing—and Winning—the Regulatory Game

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 QMS Solutions Streamline the Management of FDA cGMP Requirements

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:

  • Document Control/ Document Management
  • Training Management
  • Audit Management
  • BOM Management
  • Supplier Management
  • Change Control Management
  • Customer Complaints Software
  • Submissions Management
  • Forms-Based Process Automation

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.

How MasterControl Ensures Compliance with FDA cGMP Guidelines

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:

  • MasterControl Documents™ automates the entire lifecycle of all documents-based processes, including task assignment/routing, follow-up, tracking, escalation, review, and document approval.
  • MasterControl Training™ automates the assignment and monitoring of training tasks and the grading of online exams to ensure compliance with FDA cGMP. It automatically sequences all training courses, so that, after a prerequisite course is completed, the next one is launched. The software also provides a group sign-off feature for verifying the training of large groups of employees. Training management can be integrated with the rest of the quality system, so that any change to a document or process that warrants new training will automatically invoke training tasks upon approval of the change.
  • MasterControl CAPA™ connects with various quality subsystems to track incidents, starting with problem identification and analysis, proceeding, when warranted, to corrective action (CAPA). A CAPA can automatically be launched from another form, with the software automatically entering all relevant data to ensure compliance with FDA cGMP.
  • MasterControl Change Control™ streamlines the change control procedure for faster turnaround. It offers a best practice form that incorporates the latest requirements for FDA cGMP, GCP, and GLP.
  • MasterControl Nonconformance™ is designed to automate, manage, and streamline the process for identifying, evaluating, reviewing, and handling of any nonconforming materials and finished products to ensure compliance with the guidelines of FDA cGMP.

For More Information on FDA cGMP

For more information about FDA cGMP or our software that ensures GLP or GCP compliance-- please feel free to contact a MasterControl representative.