Visu

Visu is a Regulatory Information and Process Management (RIMS) platform designed for life sciences organizations. It digitizes, streamlines, and automates business processes across regulatory, document, submission, labeling, clinical, and CMC functions. The platform is built to serve a range of sectors including Pharma and Biotech, Medical Device and Diagnostics, Consumer Health, and Chemical and Related Industries.

Visu is structured to adapt to the people involved in decision-making and workflow, the front-end and back-end systems within an organization and external agencies, and the ongoing changes in roles, policies, regulations, and IT systems. The platform is positioned as a flexible solution that can handle exceptions, manage change, and address evolving requirements across the user community.

Industry-Specific Applications

• Pharma and Biotech: supports submissions tracking and compliance management across the product lifecycle
• Medical Device and Diagnostics: manages complex regulatory requirements and device history records
• Consumer Health: addresses product safety and compliance in fast-moving consumer markets
• Chemical and Related Industries: provides adaptable process management for chemical regulatory standards

Key Platform Capabilities

• Intuitive User Experience: standardized architecture reduces training requirements; supports configuration of custom views, forms, and dashboards in a single location
• Cross Solution Compatibility: all process solutions operate together without interference, enabling automatic deployment of changes
• Bi-directional Integration: configurable to connect with existing enterprise systems
• Responsive and Multilingual: accessible on PC, Mac, tablet, or mobile via any HTML5-supported browser, with multilingual support included
• BI Dashboards: supports predefined and custom reports; Visu data can be visualized with third-party BI tools
• Automated Workflow Engine: process parameters can be modified without IT involvement; architecture supports automatic upgrades
• Collaboration and Roles: users engage with tasks and approvals; process managers can identify bottlenecks and optimize workflows
• Speed and Scalability: designed for fast market response to changing conditions and regulations

Stakeholder-Specific Features

• Executives: visibility and control over processes, strategic oversight, and business activity monitoring
• Process Owners: intuitive usability, code-free capabilities, and root cause analysis tools
• IT Personnel: reliable and scalable platform, rapid development support, and robust administration

Related Solutions

• Regulatory Information Management (RIM) for Medical Devices: a modular regulatory and process platform for medical device organizations
• Regulatory Impact Assessment (RIA) for Medical Devices: supports proactive regulatory planning
• Regulatory Publishing Automation for Pharma and Biotech: automates document publishing processes

Visu provides Roundtrip Optimization (RTO) tailored to different organizational roles. The platform supports global regulatory operations through multilingual capabilities and bi-directional integration with existing enterprise systems. It is applicable to organizations requiring compliance with standards such as eIFU and UDI for medical devices.