Key Features/Benefits

  • Efficiently triages and reviews all inbound complaints from different sources
  • Performs robust investigation and root cause analysis
  • Multi-channel capabilities: email, fax, online chat, etc.
  • Integrates seamlessly with PV systems to publish adverse event cases
  • Customizable workflow
  • Provides actionable reports and analysis to stake holders for better decision making
  • Balances workload and ensures effective resource utilization with automated workflows

Background

Life science companies receive any number of product complaints from a disparate number of sources, each of which can put patient safety and company reputation at risk. The need to resolve each complaint quickly and with full reporting compliance is a business-critical activity that demands process efficiency. For many companies, the mechanisms for handling the intake, investigation, oversight and response to complaints is laborious and time consuming.  Unfortunately, it is a process that eludes many organizations since inadequate handling and management of product complaints is one of the top findings in the FDA warning letters to pharmaceutical and healthcare companies.

LifeSphere Product Complaints™ - Product Complaint Management System

LifeSphere Product Complaints is a fully integrated, end-to-end product complaint (PC) management solution designed to log and track complaints and respond with timely resolutions to customer issues, allowing departments to perform investigative and root cause analysis.  It enables fulfilment/response of the complaint by providing easy access to approved, accurate and consistent content using its content management features. LifeSphere Product Complaints can easily be integrated with any safety system and has standard integration with LifeSphere Safety Database, ArisGlobal’s pharmacovigilance (PV) comprehensive safety system, and LifeSphere MI, our medical information management system.

LifeSphere Product Complaints has multi-channel capabilities including email, fax, online chat, etc., and provides actionable reports and analytics. A flexible system, it can easily integrate with other company systems such as salesforce.com. Unlike many legacy systems, LifeSphere Product Complaints is Web-based and built with highly configurable and scalable modern technology on a cloud platform.

Offering a highly flexible and customizable workflow, LifeSphere Product Complaints eliminates redundant processes and streamlines interdepartmental information flows, preventing delays and/or loss of critical information due to manual or disparate processes. The system also helps minimize compliance risks, acting as a single point of capture safety cases, directing them to the most appropriate department for follow-up and resolution.

adverse event reporting software