21 CFR Part 11

21 CFR Part 11 compliance is regulated by the FDA, and is set forth to guide the safety and quality of life science products. MasterControl Inc. goes beyond software to provide regulated life science companies with the solutions they need to face the everyday challenges of business and 21 CFR Part 11 compliance. MasterControl suite automates, streamlines, and effectively manages every stage of the product development cycle, from change control to handling customer complaints.

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 solutions. MasterControl software is specifically designed to help life science companies sustain compliance with FDA regulations like 21 CFR 11 and EU quality standards. MasterControl™ suite incorporates industry best practices for automating and connecting every stage of the product development cycle. Hundreds of companies worldwide use MasterControl for better GxP process management and faster compliance with 21 CFR 11 regulations.

21 CFR 11 Compliant Software Solutions—Easy Validation, Easy Deployment, Easy Maintenance
With over a decade of experience in the FDA and EU regulated environments, MasterControl 21 CFR 11 software solutions are specifically designed to address the challenges of compliance. 21 CFR 11 compliant software solutions provide the security and electronic signature features necessary for regulated companies to ensure compliance. MasterControl™ suite offers a complete approach to fulfilling industry best practices with the following integrated software applications:

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

 GxP Process Management Support
Life science companies must learn to compete in a competitive market marked by increasing globalization, the heightening demand for faster and more cost-effective production methods, and stringent FDA and EU regulations. MasterControl provides educational and research resources specifically for regulated life science companies concerned about 21 CFR 11 regulatory compliance.

• GxP Lifeline: a complimentary monthly newsletter featuring stories, articles, best-practice tips, a list of life science events, and more. This newsletter acts as a virtual space where regulated companies can learn more about 21 CFR 11 and other regulations that guard their specific sectors.
• Education Centre: is dedicated to the education of life science companies providing industry white papers, case studies, tech papers, 21 CFR 11 software product data sheets, online demonstrations, and more.

 
Contact MasterControl Today
MasterControl 21 CFR 11 software solutions provide easier compliance, faster validation, and better process management across an enterprise. To learn more about MasterControl 21 CFR 11 compliant software, contact MasterControl online or call toll free at 1.800.825.9117 to speak with a representative.

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• 21 CFR Part 11 Compliance
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