FDA cGMP

Software Facilitates Process of Managing Requirements for FDA cGMP

The process of complying with the requirements of FDA's Current Good Manufacturing Practices -- or cGMP -- is sometimes viewed by FDA-regulated companies to be a time consuming and expensive ordeal. In fact, the opposite is true: not complying with current FDA cGMP can be a time consuming and expensive ordeal.

FDA's current regulations for GMP (FDA cGMP) are there to ensure that products are consistently produced in a controlled environment with quality standards guiding their intended use. For well over a decade, MasterControl Inc. has led the quality management software industry by providing the products, training, and support services that companies need in order to sustain compliance and increase their production.

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How Software from MasterControl Helps Streamline the Management of FDA cGMP

MasterControl offers software applications that greatly facilitate compliance with the FDA cGMP. Some of our integrated, easy-to-use applications include:

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

The above applications are only a few of the solutions that MasterControl offers to facilitate compliance with the FDA cGMP.

How the MasterControl Suite Ensures Compliance with the Guidelines for FDA cGMP

The MasterControl Suite includes the following integrated applications as well as many other applications:

• 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 current requirements for GCP, GLP, and GMP.
• 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.