21 CFR Part 11 Compliance

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 for life science companies. The MasterControl ™ suite is easy to use, easy to deploy, easy to validate, and easy to maintain so regulated companies can attain and sustain 21 CFR Part 11 compliance, and receive software ROI faster. With over a decade of experience creating software for companies within the FDA environment, MasterControl has created time-tested software solutions employed life science companies worldwide.

MasterControl GxP Process Management Software—Helping Regulated Companies Sustain 21 CFR Part 11 Compliance Year after Year

MasterControl believes 21 CFR Part 11 compliance is a state, not an event. MasterControl provides the software tools and the technical and customer service support to help companies sustain compliance year after year. MasterControl GxP process management software, the MasterControl suite, includes a continuum of integrated applications that optimize quality and business processes and foster efficiency. All of these elements combine to offer a 21 CFR Part 11 compliance solution that keeps companies compliant, connected, and complete. The MasterControl suite applications include the following:

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

The Goals of GxP Lifeline: Collaboration and Education

GxP Lifeline is a complimentary electronic newsletter published monthly by MasterControl. Within each edition, life science companies can find feature stories and articles, a monthly best practice tip, and a list of life science events such as trade shows and conferences that are happening all around the world.

MasterControl hopes life science companies will subscribe to GxP Lifeline as an educational resource where they can learn more about everything from the specifics of 21 CFR Part 11 compliance, to the solutions for the top five challenges of handling customer complaints.

For More Information

21 CFR Part 11 is here to stay. Companies competing within the rigorously regulated FDA environment must learn to effectively and efficiently manage every stage of the product development lifecycle to ensure that they reach the industry and company goals of sustained 21 CFR Part 11 compliance.

To learn more about MasterControl GxP process management software and how it helps hundreds of companies around the world sustain 21 CFR Part 11 compliance, visit MasterControl online or call toll free at 1.800.825.9117 to speak with a representative.

Related Items:

• FDA
• 21 CFR Part 11 Software
• 21 CFR Part 11 Training
• Life Science Research
• FDA Guidelines
• GMP Guidelines
• GMP Regulation
• Internal Audit Reporting