FDA Guidelines

While FDA guidelines effect change in the life science industry, compliance and traceability have become of high priority for many manufacturing companies. Traditionally speaking, sustaining regulatory compliance to FDA guidelines was considered a “cost of business.” Today, MasterControl Inc. provides dynamic GxP process management software solutions to help regulated companies eliminate the pain and cost of complying with current industry FDA guidelines

About MasterControl Inc.

MasterControl Inc. is a leading provider of GxP process management software solutions specifically designed to help life science companies comply with FDA guidelines and EU regulations. With more than a decade of experience, MasterControl has developed MasterControl™ suite—a software solution that is easy to use, easy to validate, and easy to maintain. It incorporates industry best practice and FDA guidelines for automating and connecting every stage of the product development cycle. From the laboratory to the consumers' shelf, MasterControl helps hundreds of companies worldwide sustain compliance sooner, experience validation faster, and maintain better GxP process management throughout their enterprise.

White Paper Downloads - FDA Requirements

	White Paper Download: Automating Training Management and Training Control Processes in FDA and ISO Environments
	Product Data Sheet: Automating Document Control Processes in FDA and ISO Environments
	White Paper Download: FDA 21 CFR Part 11 - Risks of Noncompliance

Implement FDA Guidelines in the Everyday GxP Processes of a Life Science Company

FDA guidelines include 21 CFR Part 11, 210-211, 820, and 606. The FDA environment is rigorously regulated, making quality and processes control a vital part of any life science companies' success. Many life science companies, however, lack visibility and efficiency when it comes to tracking and controlling GxP process management across each department.

MasterControl's GxP process management software solution, MasterControl™ suite, is a complete approach to compliance, giving regulated companies the visibility they need to effectively and efficiently manage their quality and document control processes according to FDA guidelines. MasterControl™ suite includes the following continuum of integrated, web-based software solutions:

• MasterControl Documents™
• MasterControl CAPA™
• MasterControl Training™
• MasterControl Forms™
• MasterControl Change Control™
• MasterControl Audit™
• MasterControl Customer Complaints™
• MasterControl Nonconformance™
• MasterControl SOX™

Learn More about FDA Guidelines

The competitive nature of the life science industry makes research and education imperative. MasterControl provides life science companies with the resources they need to make the right decisions about regulatory compliance with the MasterControl Education Centre and MasterControl newsletter, GxP Lifeline

.Contact MasterControl Today

By combining an integrated platform with a continuum of risk-based, time-tested software validation products and services, MasterControl offers the complete approach to compliance with FDA guidelines. To learn more about current FDA guidelines and MasterControl's software solutions, contact MasterControl online or call toll free at 1.800.825.9117 to speak with a representative.

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