Calyx RIM Reviews & Product Details

RegDesk is the next generation RIMS software with AI technology built exclusively for medical device and diagnostic companies. It is a one stop solution for regulatory teams.

RIMS (Regulatory Information Management System) allows companies to team up, preserve application information data from various locations and enhance the processes of preparing a submission, as well as simplify the publishing and tracking of all regulatory activities that support a product’s complete life cycle.

LifeSphere Regulatory is a comprehensive, cloud-based platform designed to streamline regulatory information management for life sciences organizations. By integrating data, content, and processes into a unified ecosystem, it enhances efficiency, ensures compliance with global regulations, and fosters collaboration across departments. Key Features and Functionality: - Regulatory Information Management (RIM: Offers robust capabilities for product information management, regulatory planning, tracking, and data management, increasing data quality and global oversight. - Product Compliance: Manages medicinal product data submissions throughout submission, post-submission, and post-approval stages in accordance with Identification of Medicinal Products (IDMP requirements. - Document Management: Provides a centralized content repository for seamless document and content management, including template management, workflows, advanced rendering, and permissions. - Submission Management & Publishing: Consolidates submission and publishing workflows, simplifying the creation, compilation, and publication of submissions in various formats. - Labeling: Streamlines end-to-end labeling change management and compliance tracking workflows, driving greater efficiency and consistency. - Regulatory Analytics: Utilizes preconfigured dashboards and reports to address common regulatory tracking, reporting, and analytical needs. Primary Value and User Solutions: LifeSphere Regulatory addresses the challenges of managing complex regulatory processes by providing an intuitive and flexible suite focused on risk reduction, collaboration, and efficiency. Its modern cloud architecture ensures compliance with evolving regulations through regular updates and future-proof features. By integrating with other LifeSphere systems, such as Safety and Quality, it offers a holistic approach to regulatory affairs management, enabling organizations to accelerate approvals, reduce risks, and streamline collaboration across departments.

Validfor is a digital validation lifecycle management platform that modernizes how regulated organizations manage their computerized system validations. Designed for the life sciences, pharmaceutical, and medical device industries, Validfor centralizes all validation activities in one secure and compliant environment. By replacing traditional manual validation with a digital, data-driven approach, Validfor enables teams to plan, execute, and track validation processes with real-time visibility and accuracy. The platform includes built-in templates, electronic approvals, and full traceability to ensure regulatory compliance and consistent documentation quality. Whether you’re managing a single system or an enterprise-wide validation program, Validfor helps your organization stay audit-ready, improve collaboration, and maintain complete data integrity while saving time and reducing compliance risk.

One platform for content, data, and process transformation. CARA removes the technological and financial drawbacks of a network of individual systems – instead, you can consolidate complex regulated business processes, data and content onto a single, unified platform with a single license fee