Serious Adverse Event


MasterControl Inc. has years of experience helping FDA-regulated companies address the challenges of managing serious adverse events.

A serious adverse event in the pharmaceutical or medical device industry could indicate grave safety and quality issues. Life science and medical technology companies must sustain dependable methods of managing any serious adverse event according to industry best practice. This can be a challenge. MasterControl Inc. has years of experience helping FDA-regulated companies address the challenges of managing serious adverse event. Their trusted GxP process management software offers real solutions to real compliance challenges.

About MasterControl Serious Adverse Event Solutions

MasterControl Inc. is a leading global provider of GxP process and document management software, helping FDA-regulated companies address the challenges of compliance. MasterControl suite applications include software solutions to automate, streamline, and effectively manage document control, customer complaint management, serious adverse event handling, change control, audit control, and more.

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Connect Serious Adverse Event Handling and CAPA Management with MasterControl GxP Process Management Software

FDA-regulated companies invest thousands of dollars in the implementation of a quality management system, yet they are still faced with disconnected processes that decrease manufacturing efficiency. MasterControl's GxP process and document management software system, MasterControl suite, includes a continuum of integrated applications that ensure a connected solution to compliance.

MasterControl CAPA connects the customer complaint process to the rest of the quality system, providing links to CAPA and serious adverse event handling. MasterControl CAPA also includes the following features:

  • Automated tasks
  • Simple three step process to move a serious adverse event to resolution
  • Analytics and reporting tool
  • Part 11 compliant features
  • Web-based platform
  • MedWatch form
  • Proactive monitoring

For More Information on Serious Adverse Event

MasterControl CAPA is the software solution to handling any serious adverse event natural science companies may face. In order to help regulated companies make the right decisions about sustaining regulatory compliance, MasterControl has developed a comprehensive site to help life science and medical companies learn more about FDA and ISO regulations, industry current events, and serious adverse event management options.

The Resource Center includes industry white papers, tech papers, case studies, serious adverse event software product data sheets, online demonstrations, and more.

Contact MasterControl Today for More Information on Serious Adverse Event

Ensure that serious adverse event handling is carried through to resolution with MasterControl CAPA. To learn more about MasterControl's serious adverse event software solution contact MasterControl online , or call toll free at 1.800.825.9117 to speak with a representative.