Efficient management of regulatory affairs
Regulatory Information Management solution
Centralized Regulatory Information Management (RIM) solution to efficiently manage your regulatory data, activities, processes, submissions and commitments
RImanager is a centralized master data driven Regulatory Information Management solution, which provides organizations the capability to manage their product portfolio with effortless compliance. It allows you to manage your master data as well as to plan and track related regulatory data, activities, processes, submissions and commitments across departments on a global scale. With RImanager you will have all your regulatory affairs activities transparent at anytime and anywhere.
Connecting your regulatory and production processes
RImanager manages all your product master data. Regulatory activities can be defined that store and track the information related to each product and its related submissions. As RImanager is built upon Werum’s PAS-X MES platform, it can also be integrated tightly into your manufacturing processes. This ensures that information regarding labelling, formulation and drug safety remain in a single repository, allowing instant access for your end-users and providing essential management and regulatory reporting capabilities.
Effectively manage your regulatory projects
RImanager also includes a set of powerful project management tools to help you to structure and control your overall regulatory processes. Using the built-in task management tools, you can assign specific activities to departments or teams of users. Direct links between tasks and business objects such as manufacturing sites, pharmaceutical products, formulations or submission documents allow quick and accurate access to related objects. For more complex processes, RImanager’s workflow engine enables you to assign tasks in sequence to a number of users. The fully audited workflows can also be used to manage review and approval processes. RImanager’s real-time email alerts provide instant notification to users about up-coming tasks or activity deadlines. RImanager also includes version control capabilities that allow you to track and control the status of every object within the system. For example, by making changes to a new “Draft” version of an object, you are able to modify it without affecting the currently published version.
Goals and drivers
- Manage master data for your product portfolio
- Powerful project management tools to plan and track regulated activities, tasks and resources
- Structured data driven system that supports IDMP (Identification of Medicinal Products) exchange to authorities
- Supports EU and USA regulatory procedures and lifecycle maintenance
- E-mail alerts
- FDA CFR 21, Part 11 compliant
- Confluence of regulatory affairs and state-of-the-art technology
- Single source of information for your regulatory product maintenance
- Developed and supported by the leaders in manufacturing execution and regulatory affairs software
- Regulatory activity planning made easy
- Assign tasks and responsibilities to relevant people
- Readily generate management reports
- Reduce time and effort creating product documentation and regulatory submissions
- Access current and legacy product data from a single interface