A customer complaint in the natural science company could indicate a more serious adverse event. MasterControl Inc. is a leading GxP process management software provider dedicated to providing integrated, easy to use solutions to managing any serious adverse event.

About MasterControl Inc.
MasterControl Inc. is a global provider of GxP process management software helping companies manage serious adverse event to attain and sustain compliance year after year. With years of industry experience, MasterControl was the first company to develop a software solution that specifically addressed FDA requirements. With dynamic software solutions and the support of technical and customer services, it is no wonder over 400 companies around the world employ MasterControl GxP process management software.

Managing Serious Adverse Event with the Leading Software Solutions
Customer complaints are inevitable in any business. In the FDA regulated environment, companies must manage these complaints before they turn into a serious adverse event because the quality and safety of their products depend upon it. MasterControl Customer Complaints™ addresses the challenges of managing a serious adverse event with the following features:

• A secure and centralized platform for receiving notice of a serious adverse event
• Stores documentation pertaining to the investigation and correction of a serious adverse event
• Web-based platform allows customers to log complaints from virtually anywhere
• Connected applications with CAPA processes and change control
• Dynamic tracking capabilities ensure managers know the state of their company’s customer complaint process
• Advanced reporting capabilities
• Continuous monitoring
• Streamlined 3-step process

Implementation and Validation Methods
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.

Regulated companies must also comply with industry best practice when implementing software and seeking continuous validation. With more than a decade of experience, MasterControl has developed time-tested implementation and validation methods to help companies realize software ROI faster and deploy serious adverse event software sooner.

• Implementation Services: MasterControl combines industry best practice with the database creation, installation, and configuration serious adverse event software solutions require.
• Validation Methods: FDA regulations pertaining to electronic records and electronic management guide natural science companies through the software validation process. Companies can realize continuous validation with full-cycle validation, the validation toolkit, and continuous development

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

  Questions? Contact MasterControl Today
A serious adverse event can indicate a quality or safety issue. To learn more about MasterControl’s complete approach to serious adverse event management, contact MasterControl online or call toll free at 1.800.825.9117 to speak with a representative.

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• Serious Adverse Event
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