Adverse Drug Event


MasterControl Inc. provides GxP process management software solutions to help regulated FDA companies comply with adverse event reporting regulation effectively and efficiently.

An adverse drug event within the FDA environment refers to any undesirable change in health that occurs in a person after they have enrolled in a clinical trial. In order to monitor drug safety, the FDA requires that each adverse drug event be reported and reviewed by the Center for Drug Evaluation and Research (CDER). MasterControl Inc. provides GxP process management software solutions specifically designed to address the challenges of compliance within the rigorously regulated FDA environment.

About MasterControl Adverse Drug Event Solutions

MasterControl Inc. is a leading global provider of GxP process management software solutions. Since 1993, MasterControl has been providing FDA regulated companies with the software solutions they need to attain and sustain regulatory compliance. 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 safeguarding of adverse event reporting processes. Hundreds of companies worldwide use MasterControl for easier compliance, faster validation, and better GxP process management.

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Sustaining Regulatory Compliance While Managing an Adverse Drug Event

Outdated paper based process management methods are messy, to say the least. They also foster inefficiency, disconnected processes, poor reporting systems, and a lack of oversight. If a life science company does happen to come across an adverse drug event, a paper based management method simply won't cut it.

MasterControl™ suite provides the software solution regulated life science companies need to sustain compliance with FDA regulation. When customer complaints, deviations, adverse drug event, and other incidents occur, MasterControl software solutions use automated routing, notification, delivery, escalation, and approval to launch and track all related documents. All of the documents and forms needed to report an adverse drug event to the FDA are easily accessible due to MasterControl's advanced tracking system.

To learn more about making the right decisions when it comes to managing an adverse drug event, visit MasterControl's Education Center to find informative white papers and other valuable resources.

Life Science Industry Education and Collaboration

With an ever-increasing movement towards globalization, the life science industry is becoming more competitive. MasterControl provides the educational and research materials regulated companies need to stay abreast of industry current events, software solutions, and collaborative endeavours.

MasterControl's complimentary monthly newsletter, GxP Lifeline, is aimed at providing life science companies, especially those within the pharmaceutical, biotechnology, medical devices, blood/tissue, and clinical/medical laboratory sectors, with informative and interesting stories and articles. GxP Lifeline also includes a monthly best practice tip and a list of upcoming life science events to help companies make the right decisions about managing an adverse drug event and every other part of their GxP process.

Contact MasterControl Today for Adverse Drug Event Solutions

To learn more about how MasterControl suite provides solutions for automating, streamlining, and effectively managing every step of the product development cycle, including the possibility of an adverse drug event, contact MasterControl online or call toll free at 1.800.825.9117 to speak with a representative.