Current Good Manufacturing Practices (cGMP)
How to Assure a System that Complies to the Requirements for Current Good Manufacturing Practices (cGMP)
The process of complying with the requirements of current good manufacturing practices or cGMP is considered by many FDA-regulated companies to be a time consuming and expensive ordeal. In fact, the opposite is true: not complying with cGMP can be a time consuming and expensive ordeal.
FDA's cGMP regulations ensure that products are consistently produced in a controlled environment with quality standards guiding their intended use. For over a decade, MasterControl has led the quality management software industry providing the products, training, and support companies need to sustain compliance.
The MasterControl Suite Ensures Compliance with the Guidelines for cGMP
The MasterControl Suite includes the following integrated core applications:
- MasterControl Documents™ automates the entire lifecycle of all documents-based processes, including task assignment/routing, follow-up, tracking, escalation, review, and approval.
- MasterControl Training™ automates the assignment and monitoring of training tasks and the grading of online exams for current good manufacturing practices compliance. It also allows training courses to be sequenced, so that after a prerequisite course is completed, the next one is automatically launched. In addition, the software 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 MasterControl quality system, so that any change made to a document or process that warrants new training will automatically invoke new training tasks upon approval of the change to ensure current good manufacturing practices throughout enterprise.
- MasterControl CAPA™ interconnects different quality subsystems to track incidents, beginning with the initial problem identification and following through to the final resolution. A CAPA can automatically be launched from another form, which will cause all relevant data about cGMP to be automatically entered into the CAPA form.
- 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.
- To ensure compliance with cGMP guidelines, MasterControl Nonconformance™ is designed to automate, manage, and streamline the process for identifying, evaluating, reviewing, and handling of any nonconforming materials or finished products.
For More Information on Current Good Manufacturing Practices (cGMP)
For more information about current good manufacturing practices cGMP, or how MasterControl can help your company meet good manufacturing requirements, please feel free to contact MasterControl representative.