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EXTEDO / Werum RImanager - Regulatory Planning and Tracking Software
A centralized Regulatory Information Management System (RIMS) to manage your company assets
RImanager is a master data driven solution, which provides organisations the capability to manage its product portfolio with effortless compliance. It allows you to plan & track all your registrations across departments on a global scale. With RImanager you will have all your regulatory affairs activities transparent at anytime and anywhere.
Regulatory departments are the brains within the pharmaceutical industry, you are ultimately responsible for the life of your company’s assets. Not only do you have very high standards of regulations that must be followed, you also have to coordinate complex activities with multiple stakeholders to ensure medicines can be assessed effortlessly for quality; efficacy and patient safety.
We live in a world where there is an expectation that relevant stakeholders have the most accurate information at a click of a button. Time is limited and standards like IDMP must be adhered to, tracking registration deadlines, planning maintenance submissions and keeping control of related projects can quickly become unachievable. However, failure to manage this effectively can result in compliance gaps and potential risk to patient safety.
Within many companies these processes rely on intensive manual effort, supported by Excel and other disconnected IT solutions such as regulatory product databases and manufacturing execution systems. Not only does this require significant IT effort to maintain, but more importantly the individual silos create disconnects between operational and regulatory information. This makes the alignment of the registration and manufacturing processes significantly more complex and increases the opportunity for errors within documentation and submissions.
- Confluence of Regulatory and Technology to make your life easier
- Manage master data for your products
- 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
- Powerful Project Management functionality
- 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
Your single solution for managing Regulatory Information
EXTEDO / Werum RImanager is a centralized Regulatory Information Management System (RIMS) that enables you to efficiently manage your master data as well as plan and track related regulated data, activities, processes, submissions and commitments.
Regulatory Activity becomes the central trigger for all impacted changes and RImanager opens up transparency within your company.
As a part of the EXTEDOsuite, RImanager ensures that you have a single source of truth for all your regulatory product data. RImanager supports product registration, submission management and pharmacovigilance processes, and its open architecture queried through the same intuitive user interface.
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 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.
Used in combination with EXTEDO MPDmanager, RImanager supports the transmission of both the XEVMPD and IDMP standard data to regulatory authorities, allowing information to be readily shared without the need for exports or manual re-keying.
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 upcoming 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.
Regulatory Intelligence Services
Like products themselves, regulations are subject to continual maintenance and updates. When this happens, regulatory departments are directly impacted and are responsible for implementing the change within their business as well as communicating them to other key stakeholders.
EXTEDO understands the complexities associated with the lifecycle of a regulated product. The management of Marketing Authorizations relies on an equal balance of data accuracy, streamlined change control procedures and effective communication between multiple stakeholders. The use of defined processes is essential. With regulatory standards such as xEVMPD and the future IDMP, it is also necessary to ensure that you have the necessary data captured and managed for each product. With data coming from many different sources the challenge is collecting, structuring and migrating it correctly.
We can help you managing that.
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Purchasing a new EXTEDO application is the first step to streamlining business and regulatory processes within your organization. However, ensuring correct installation, implementation and integration is a crucial step in the process of deploying your new solution.
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Education & Training Services
To ensure you get the most out of your purchased solution, we offer detailed training for each product within the EXTEDOsuite solution portfolio. Training sessions are tailored to your individual needs and cover a broad range of technical and regulatory topics.
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