21 CFR Part 11 Software

MasterControl Inc. is a leading GxP process management software company providing 21 CFR Part 11 software solutions to help regulated companies effectively face the challenges of conducting business.

Organizations regulated by the U.S. Food and Drug Administration (FDA) like pharmaceutical, biotechnology, medical device, and others continue to face the daily challenges of complying with 21 CFR Part 11. MasterControl Inc. is a leading GxP process management software company providing 21 CFR Part 11 software solutions to help regulated companies effectively face the challenges of conducting business.

White Paper Downloads on 21 CFR Part 11

	White Paper: MasterControl's Product Positioning in Regards to 21 CFR Part 11 - Automating the Management of Documentation
	White Paper: 21 CFR Part 11 - Are You Ready for an FDA Inspection?
	White Paper: 21 CFR Part 11 - Risk of Non-compliance
	White Paper : 5 Ways to Ensure System Compliance with 21 CFR Part 11
Click here to view all available resources.

About MasterControl Inc.

MasterControl Inc. is a leading global provider of GxP process management software helping hundreds of companies worldwide attain and sustain compliance to FDA and EU regulations. Adhering to industry regulations like 21 CFR Part 11 is a significant undertaking for most companies. However, with 21 CFR Part 11 software solutions by MasterControl Inc., this effort is beneficial, allowing the company to capitalize on current technology to automate, streamline, and effectively manage all quality control and business processes.

MasterControl suite incorporates business best practices to automate and connect every stage of the product development cycle in order to facilitate regulatory compliance. MasterControl suite applications promise an integrated, web based platform with connected applications that provide a complete 21 CFR Part 11 software solution. MasterControl suite includes the following software application continuum:

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

Implementing and Validating 21 CFR Part 11 Software Solutions

MasterControl Inc. 21 CFR Part 11 software solutions are focused on FDA compliance in all areas and departments of life science companies. With more than a decade of experience, MasterControl has developed time-tested implementation and validation services to ensure compliance with 21 CFR Part 11.

• 21 CFR Part 11 Software Implementation Services : MasterControl's experienced team works with each company's IT Department to ensure database creation, installation, and configuration.
• 21 CFR Part 11 Software Validation Services : includes full-cycle validation, validation toolkit, and continuous development to ease the burden and complexity of validation.

MasterControl technical and customer services support help companies deploy software sooner and receive software ROI faster.

Life Science GxP Lifeline to Education and Collaboration Resources

MasterControl's complimentary monthly newsletter, GxP Lifeline, is a virtual space dedicated to helping life science companies learn more about 21 CFR Part 11 software, FDA and EU regulations, and best practice tips. Each monthly edition of GxP Lifeline includes features articles, stories, and life science industry event news so companies can make the right decisions about 21 CFR Part 11 software and regulatory compliance.

For More Information

To learn more about 21 CFR Part 11 software solutions, contact MasterControl online or call toll free at 1.800.825.9117 to speak with a representative.

Related Items:

• 21 CFR Part 11 Compliance
• 21 CFR Part 11 Training
• FDA Compliance
• Regulatory Compliance
• GMP Guidelines
• GMP Regulation
• FDA Guidelines
• Life Science Research