Align Risk management business process with Signal Management and Periodic Reports



The current processes for identification, evaluation and categorization of risks and the associated management of the risk minimization measures including local implementations 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 and re-work. The current process may appear to satisfy immediate needs but is largely error prone, hard to secure, monitor and audit. The lack of alignment of Risk Management, Signal 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 a one stop shop solution by integrating risk identification, categorization, evaluation and the downstream management of risk minimization measures including local implementation plans. It also provides the capability to plan, schedule, author and distribute RMP documents while bringing the content attributes for use and reuse, with speed, an adherence to information compliance and reporting. The solution can also leverage data from your existing signal detection systems thus leveraging your existing systems and business processes where applicable.


Automate risk assessment, categorization and risk minimization activities.
Align Risk Management process with Signal Management and Periodic Reporting processes
Track Risk Commitments, Risk Minimization activities (RMM, aRMM) and Local Implementation Plans
Automate authoring, re-use and production of risk management plans – CC‐RMP, EU‐ RMP, Local RMP and others.

Ready to align RMP with PBRER/PSUR?


Key Features

  • Manage end-to-end risk management process including planning, scheduling, report generation and submission tracking
  • Optimize reporting plans utilizing harmonization strategies to reduce total overall reports.
  • Ensure conformance to standards, templates and regulations
  • Manage Review and Approval workflow process
  • Align RMP Planning, Risk Classification, Risk Minimization activities, RMP authoring and submission processes
  • Align Risk Management, Signal Management, Periodic Reports and PRAC Management processes
  • Collaborate with other departments, partners and local affiliates
  • Generate dashboards and reports for different levels of management