All processes carried out under the Risk Management Plan (RMP) for medicines subject to additional monitoring are managed securely, traceably and in compliance with regulations on a single platform.
The RMP Management System moves the entire workflow to the digital environment — from prescribing to prescription approval, from drug supply to reporting. It enables all users involved in the process to manage their tasks on a role basis, while storing all records on a secure infrastructure with full traceability.
Features
Compliance with RMP Processes: Supports the complete fulfilment of all required conditions during the prescribing of medicines subject to additional monitoring, and ensures that processes are conducted in accordance with the Risk Management Plan.
Web-Based, Role-Based Management: Physicians, pharmacies, pharmaceutical warehouses, pharmacovigilance officers and other authorized users can securely perform their assigned tasks through a web browser.
Secure and Centralized Data Management: All process data is stored in a secure database. Data integrity is preserved, every transaction is recorded, and retrospective traceability is ensured.
Single-Point Access to All Prescription Information: Prescription images, patient eligibility assessments, prescription approval forms and all related documents are linked to each prescription and can easily be viewed on a single screen.
Automatic Prescription Approval Form Generation: Prescription Approval Forms are prepared automatically from the information entered into the system. This reduces manual data entry, minimizes the risk of errors and shortens processing times.
Integrated E-Mail Management: All e-mail correspondence related to the process is stored within the platform. Prescription Approval Forms can be sent directly from the system to the relevant e-mail addresses, and all communication is recorded.
Automatic Reports: Reports requested by the Ministry of Health, the marketing authorization holder or the pharmacovigilance officer are generated automatically by the system. Reporting processes are accelerated and the operational workload is significantly reduced.
Benefits
- Detailed management of monitoring processes for medicines subject to additional monitoring
- Complete digital management of Risk Management Plan processes
- Support for regulatory compliance and process standards
- Recording of every process step and full traceability
- Reduced manual workload and increased operational efficiency
- Secure data management and a central document archive
- Fast reporting and simplified audit processes