A risk-assessment and risk-management tool to summarize experts prior knowledge (Prior-K) and investigate, quantify and prioritize risks for new or existing processes throughout the life-cycle. iRISKTM can also be customized to your User Requirements Specification.
Registration and Management of Risks Risk Register allows for a streamline environment where strategic risks are filled, managed and analyzed, while ensuring you that Risk Mitigation actions are focused on the most significant threats to your business. It allows different tiers to work together, sharing action plans and assigning risk ownership to the appropriate level.
Make your Equipment, facility, utility and process qualification effort more effective, lean, simpler and faster using iRISK4CQVTM ĘC a Quality Risk Management platform with an integrated Qualification workflow dedicated to pharma manufacturers using an electronic Quality Risk Management system. Risk assessments established in iRISK4CQVTM are founded on understanding the products or product type that will be produced at the facility/line/equipment and results in associated qualification plans.
A tool to drive horizontal integration (whole process analysis, end-to-end) and vertical integration (process history, life-cycle) and support science-driven process/product improvement and troubleshooting. iSEETM can also be customized to your User Requirements Specification.