Adverse drug event occurrences are disappointingly a common part of primary care, and many of these events are considered preventable. For life science companies involved in the development, manufacturing, and distribution of drugs, an adverse drug event can be a poor reflection of quality and safety control.

MasterControl Inc. is a leading GxP process management software provider for life science companies around the world. For over a decade, MasterControl has helped life science companies comply with industry best practice standards for handling adverse drug event occurrence.

About MasterControl Inc.
MasterControl Inc. is a leading global provider of GxP process and content management software solutions for 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 product development cycle, including adverse drug event processes, while facilitating regulatory compliance. By combining an integrated platform with a continuum of risk-based software validation products and services, MasterControl drives down the total cost of ownership and enables customers to extend their investment across the enterprise.

Effectively Manage Any Adverse Drug Event with Complete GxP Process Software Solutions
More serious than a customer complaint, an adverse drug event is telling of just how efficiently and effectively a life science company can handle product quality and safety issues. While relatively common within primary practices across the world, it is important that your life science company is capable of providing all of the information the FDA requires by regulation if an adverse drug event occurs.

MasterControl GxP process management software provides solutions for the challenges of documenting adverse drug events. MasterControl Customer Complaints™ software application features the following benefits to help you improve product quality and safety, customer satisfaction, and regulatory compliance:

• Med-Watch Form—As an FDA regulated company, you know that a customer complaint can turn into an adverse drug event. The Med-Watch form is an FDA compliant form used for mandatory reporting of adverse events, allowing a seamless handover to an adverse events specialist while ensuring that all required data is immediately collected.
• CAPA Integration—gives you the option to integrate customer-complaint handling with the corrective action preventive action (CAPA) process to automatically escalate any serious quality problem.
• Analytics and Reporting Tool—increase management oversight and demonstrate appropriate controls to regulatory agencies.
• A Secure and Centralized Server—provides a platform for receiving customer complaints and storing all subsequent documentation pertaining to investigation and correction of an adverse drug event.
• Connectivity—Allows managers to track a complaint from initiation to completion, giving them the ability to proactively improve the complaint-handling and adverse drug event handling process.

GxP Lifeline—MasterControl’s Complimentary Newsletter
MasterControl’s complimentary monthly newsletter, GxP Lifeline, is a virtual space dedicated to providing educational and resource materials for life science companies regulated by the FDA and EU. When you subscribe to GxP Lifeline you will find sector specific articles, feature stories, a monthly best practice tip, a list of upcoming life science events, and more. Subscribe to GxP Lifeline today to stay connected with the industry’s latest news. 

• Implementation Services: MasterControl combines industry best practice GMP regulation with unique customer requirements to provide optimized GxP process management software. MasterControl works alongside their customers’ IT Department to provide the implementation services, which include database creation, installation, and configuration.
• Software Validation Services: 21 CFR Part 11 and GMP regulation, include requirements to validate electronic record keeping systems. MasterControl provides full-cycle validation, a validation toolkit, and continuous development to help companies comply with industry best practices.

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
MasterControl GxP process and content management software solutions are specifically designed to meet the challenges of regulatory compliance within the FDA and EU environments. You can learn more about MasterControl’s approach to adverse drug event handling by contacting MasterControl online or calling toll free at 1.800.825.9117.

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