Is your life science company wondering how to improve regulatory compliance with FDA adverse event reporting regulations? In order to safeguard product safety and protect the public health, the FDA requires that life science companies voluntarily engage in adverse event reporting.

MasterControl Inc. provides time-tested software solutions to help regulated life science companies comply with industry best practices throughout the product development lifecycle.

About MasterControl Inc.
MasterControl Inc. is a global provider of GxP process and content management software solutions for FDA and EU regulated life science companies. The MasterControl™ suite is easy to use, easy to deploy, easy to validate, and easy to maintain. It incorporates industry best practices for automating and connecting every stage of the adverse event reporting process. By combining an integrated, Web-based platform with a continuum of risk-based software applications, MasterControl helps companies facilitate regulatory compliance in all the GxP processes. Hundreds of companies worldwide use MasterControl for easier compliance, faster validation, and better GxP process management.

Comply with FDA Adverse Event Reporting Regulation
A customer complaint, deviation, and adverse event reporting system are needed in any life science company. Yet, many companies are still practicing archaic means of collecting and recording this data, resulting in an efficient expenditure of time, man-hours, and revenue.

With MasterControl GxP process and content management software solutions, you can guarantee that all critical information pertaining to a corrective action preventive action (CAPA) or adverse event reporting form will be captured. With MasterControl software applications, MasterControl CAPA™ and MasterControl Customer Complaints™, there is no need to worry about losing or misplacing paper reports. Here are the features and benefits of MasterControl software solutions:

• Automates routing, notification, delivery, escalation, and approval of CAPAs and all related documentation.
• Provides a secure, centralized Web-based repository for all CAPA documents.
• Integrates the CAPA process with the rest of the quality system, including the adverse event reporting system, for a truly holistic approach to quality management.
• Tracks quality incidents, such as an adverse event reporting incident, so managers can have a real-time view of the current state of the product development cycle, and can then more proactively improve the quality system.
• Ultimately, MasterControl GxP software solutions help you improve product quality and safety, increase customer satisfaction, and ensure FDA and EU compliance.

Find the Research and Educational Resources You Need
Visit MasterControl’s Education Centre today to learn more about GxP process and content management software. Here you will find industry white papers, case studies, and more.

Downloads - GMP Training

	White Paper Download: Automating Training Management and Training Control Processes in FDA and ISO Environments
	Product Data Sheet: MasterControl Training
	White Paper Download: 21 CFR Part 11 - Risks of Noncompliance

  Contact MasterControl Today
To learn more about MasterControl’s dynamic approach to adverse event reporting, contact MasterControl online or call toll free at 1.800.825.9117 to speak with a representative. 

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