Risk Management

The Risk Management module offers a comprehensive approach for life science companies to effectively identify, assess, document, and track risks across their organization. It centralizes risk management documentation and maintains consistency across all quality processes.

Integrate with eQMS

This module is part of an all-in-one electronic Quality Management System (eQMS) that addresses various aspects such as document control, change management, supplier and audit management, training, CAPA processes, and more, ensuring a cohesive risk management strategy.

Streamline Documentation

Manage your Risk Analysis, Risk Assessments, and Control documents efficiently within a singular system. The tool provides automated workflows that not only streamline documentation procedures but also support compliance with regulations, offering complete visibility over workflows and upcoming tasks.

Leverage Document Templates

Create risk management documents using customizable templates provided by the system. This includes risk assessments, management plans, and traceability matrixes, with the option to import existing templates through an easy drag-and-drop feature.

Enhance Data Relationships

Effortlessly link risk management data to various quality processes, ensuring traceability. Customize how risk data is shown across processes and make relationships between risk documentation and related documentation seamless.

Regular Risk Evaluation

Develop risk management plans to periodically assess and monitor risks. The system facilitates linking risk assessments to nonconformance and deviation records, enabling re-evaluation of risks. Timely periodic review alerts help maintain up-to-date risk assessments.

Maintain Regulatory Compliance

Designed to comply with standards like ISO 13485:2016, ISO 9001:2015, ISO 14971:2019, and regulatory requirements such as GMP, ICH Q9, and EU regulations, the system supports electronic signatures compliant with FDA 21 CFR Part 11.

Use Custom Fields for Insight

Add custom fields to gain deeper insights into risk management processes. Capture strategic monitoring and data for statistical analysis using different formats like lists, numbers, dates, and text.

Audit and Inspection Ready

Facilitate easy access to risk management documentation during audits by linking relevant risk documents to regulatory standards, enhancing preparation and compliance demonstration.