One stop Signal management solution for tracking, evaluation and approval



The current processes for documenting and tracking of signals from detection to risk categorization and management is most organizations is siloed with discrete operating functions utilizing a combination of tools and manual processes. Gap in business process and tools lead to incorrect outputs and errors incurring additional cost & re-work. The solo use and access to safety risk management data may appear to safety immediate needs but is largely error prone, hard to secure, monitor, and audit. The lack of alignment of Risk Management and Periodic Reporting processes introduces inconsistency, duplication and encourages a reporting need based business process which can lead to compliance and more importantly patient safety issues.

Quartica’s solution provides the ability to leverage data from signal detection to signal validation, evaluation and approval while bringing the content attributes for use and reuse, with adherence to information compliance and reporting. It automates generation of safety review committee deliverable and enables information flow to risk management and aggregate reporting business processes.


Optimize signal validation, analysis, prioritization and evaluation processes
Automate signal evaluation reports and approval business process workflows
Automate notification of new signal or risk to Risk Management, Aggregate Reports and SDEA Partners
Automate alignment of signal with Risk Management, Aggregate Reports and other PV functions

Ready to automate your signal management process?


Key Features

  • Manage end-to-end signal management process including tracking, evaluation and approval
  • Automate generate Safety Review Committee deliverables
  • Manage Review and Approval workflow process
  • Generate audit and inspection ready reports and dashboards for different level of management
  • Align Signal Management and Risk Management processes
  • Track decision log, review and approval history for complete traceability
  • Configure organizational specific strategies to fine tune reporting plans.
  • Ensure conformance to standards, templates and regulations.