TrackWise Digital Risk Management

TrackWise Digital Risk Management provides a complete solution to proactively manage risks of pharmaceutical products, combination products, and medical devices. The built-in templates comply with ICH Q9 and ISO 14971 and can be configured based on the complexity of the products. Manage risks for the entirety of a product lifecycle directly within TrackWise Digital, resulting in patient safety and product quality being at the forefront of all quality decision-making.

Key Capabilities

Built on TrackWise Digital
TrackWise Digital is the single source of truth for all of Quality Management by connecting your risk management, complaints, and QMS processes, all on one platform. Learn more about the benefits of having TrackWise Digital with Risk management:

Benefits of TrackWise Digital with Risk Management

Built-in, Configurable Risk Analysis Tools

  • Top-Down Risk analysis – The built in Hazard Analysis links single-fault failure modes from FMEAs to hazards, and links hazards/hazardous situations to harms.
  • Bottom-up Risk analysis – The built in Failure Mode and Effects Analysis (FMEA) capability provides a listing of single-fault failure modes, and risk control activities and assignments.

Learn More about Medical Device Risk Management

Risk Review
TrackWise Digital Risk Management features built-in dashboards that provide information on progress or completion of risk management workflows, and notification of risk control activities that are required. Electronic signatures and audit trail functionality, in accordance with 21 CFR Part 11, allow for efficient and compliant cross-collaboration. Authors and approvers can be configured for each element of the risk management file to allow for targeted involvement of subject matter experts.

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