FDA Regulations

FDA regulations may be used as standards for broad-range groups and processes for automating business procedures

FDA regulations have been developed to ensure that companies implement quality management processes that will create higher quality products. In today's competitive world, businesses often struggle to meet stringent FDA regulations as they seek to balance quality control and the push to make a profit. MasterControl Inc. is the leading provider of FDA GxP quality management solutions that efficiently improve quality processes and compliance with FDA regulations. MasterControl's integrated, easy-to-use system ensures faster software ROI.

Free Resources

How to Successfully Complete an FDA Inspection

Product Videos

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: 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
Kit: 11 Free Resources to Boost Your FDA Readiness

FDA Regulations and Industries

FDA regulations affect the manner in which a wide range of industries conduct day-to-day business matters. Since 1993, MasterControl has provided an integrated quality management suite to help FDA-regulated industries attain and sustain compliance year after year. MasterControl's unique software addresses FDA regulations as well as the unique needs of companies across industries. MasterControl's FDA solutions can help companies belonging to any of the following industries:

Pharmaceutical
Medical Devices
Biotechnology
Blood/Tissue
Laboratories
Contract Organizations

Implementation and Training Services According to FDA Regulations

From more than a decade of experience working with companies in FDA environments, MasterControl has developed time-tested implementation methods for companies to meet the requirements of FDA regulations. MasterControl works closely with the customer's IT Department during the implementation phase, which includes:

Database Creation and MasterControl Installation
Database Configuration

MasterControl provides a comprehensive training program led by the professional services team. The team, which consists of FDA specialists and system administrators, conducts product training at the state-of-the-art Training Center in Salt Lake City and at customers' facilities who ensure compliance with FDA regulations.

How Important are FDA Regulations?

FDA regulations are of great importance because they set a standard which can be enforced by warning letters, 483 notices, civil money penalties, etc. Failing FDA audits and/or violating certain FDA regulations can result in major fines, negative publicity, and even consequences as serious as jail time for executives.

Contact MasterControl Today for More Details on FDA Regulations

MasterControl believes that FDA compliance is a state, not an event. With years of experience and in-depth understanding of the FDA regulations, and the latest GxP content management solutions in the industry, the MasterControl Professional Services team has helped over 900 hundred companies worldwide realize ROI faster. Begin working towards compliance today with MasterControl. Contact MasterControl online for more details on FDA regulations and your inquiry will be addressed promptly, or call toll free at 1-800-825-9117.