GXP

FDA GXP Compliant Software System

The FDA has developed a series of Good Practices (GXP) regulations to better ensure the safety and efficacy of products manufactured by a large variety of life industries. From the laboratory to the grocery store or pharmacy shelf, FDA GXP compliance requirements are there to protect the life sciences industry and the consumers they serve. MasterControl offers an integrated quality and GXP compliance management software system to FDA-regulated companies. MasterControl believes compliance is a state not an event.

Downloads

	White Paper: GAMP®5: A Risk-based Approach to Compliant GxP Computerized Systems
	White Paper: FDA's Quality Systems Approach to Pharmaceutical CGMPs
	White Paper: MasterControl/Datafarm GxP2eCTD Connector
	Webinar: GAMP 5 - A Risk-based Approach to Compliant GxP Computerized Systems

Becoming GXP Compliant

Compliant: Through an efficiency and quality business process, MasterControl helps companies attain compliance, and sustain it year after year. MasterControl provides the resources companies need to validate a software solution with onsite, full cycle validation, as well as the resources needed to follow IQ, OQ, and PQ validation test protocols.
Connected: MasterControl connects people with the data and processes needed to see the ?big picture.? This holistic view encourages collaboration and allows managers to view and monitor the entire quality system. By implementing MasterControl's integrated solution, system validation can be performed only one time.
Complete: MasterControl helps companies realize compliance as a part of corporate culture as compliance is enforced across the enterprise in every department and organization.

To learn more about GXP requirements and all the factors that go into becoming FDA compliant, visit MasterControl's Q&A . Here companies can find the answers to commonly asked questions about industry specific issues.

About MasterControl
Since its beginning in 1993, MasterControl has been at the forefront of the quality management software industry. Today, hundreds of companies worldwide use MasterControl software solutions to meet current GXP requirements. MasterControl's software has proven to be both effective and efficient in reducing the cost of managing GXP and quality.

Customer Reviews
When making an important company investment, like an integrated quality management software suite, it is important to find a system that supplies superior software and the customer service to back it up. To learn more about how MasterControl software and GXP compliant services are rated by customers all around the world, please review these case studies and customer comments.

For More Information
For more information on current GXP compliance and the software that helps companies stay compliant, connected, and complete contact MasterControl today or call toll free 1-800-825-9117.

Related Items: