FDA Requirements

MasterControl Inc. helps companies comply with FDA requirements and ISO quality standard with easy to use, cost effective software solutions.

FDA requirements and ISO quality standards guide the way regulated life science companies do business on a daily basis. These companies must comply with quality standards in order to ensure that the products they offer are both safe and of the highest quality. MasterControl Inc. helps companies comply with FDA requirements and ISO quality standards with easy to use, cost effective software solutions.

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How to Successfully Complete an FDA Inspection

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Hundreds of companies around the world use MasterControl to automate core business processes and document management activities to promote collaboration, improve decision making, and accelerate time to market.

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Free Resources

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Industry Brief: 8 Best Practices for Compliant and Quick Software Validation in the Cloud
White Paper: How to Successfully Complete an FDA Inspection White Paper: Noncompliance to FDA Quality Standards: What's the Risk to Executives? White Paper: The Value of Studying and Utilizing FDA's QSIT Manual White Paper: FDA Inspections of Clinical Investigators: Are You Ready? White Paper: Most Common Reasons for FDA Form 483 Observations and Warning Letters in Medical Device Environments

How MasterControl Helps With FDA Requirements

For over a decade, MasterControl Inc. has been at the forefront of the GxP process and document management software solutions industry. As the first company to provide a software solution that specifically addressed FDA requirements and ISO quality standards, MasterControl Inc. has the industry experience regulated companies need to comply with current industry best practices and maintain an FDA approved status.

Comply with FDA Requirements Year after Year

MasterControl's GxP process and document management software solution, MasterControl suite, is an integrated, easy to use approach to compliance with FDA requirements. MasterControl's software solutions include a continuum of configurable applications that regulated companies can choose to deploy based on the unique needs of their company and the industry in which they compete. These FDA compliant applications include the following:

MasterControl Documents™
MasterControl CAPA™
MasterControl Training™
MasterControl Process™
MasterControl Change Control™
MasterControl Audit™
MasterControl Customer Complaints™
MasterControl Nonconformance™
MasterControl Submissions Gateway™

For More Information About FDA Requirements

It is imperative that regulated companies know the FDA requirements and regulation that guides their industry. MasterControl's Resource Center is a comprehensive site dedicated to providing regulated companies with the educational and research materials they need to learn more about FDA requirements, industry current events, and quality management systems. Companies can find the following materials:

Product Data Sheets
Industry White Papers
Tech Papers
Case Studies
Q & As
Online Demonstrations

Questions About FDA Requirements? Contact MasterControl Today

Complying with FDA requirements year after year is a challenge. To learn how MasterControl's GxP process and content management software solution helps companies around the world comply with FDA requirements, contact MasterControl online or call toll free at 1.800.825.9117 to speak with a representative.