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Simplifying the management of IDMP and other medicinal product information
With the imminent introduction of the new IDMP standards, organizations will need to capture and manage significantly more regulatory data for each medicinal product than under the existing XEVMPD requirements.
IDMP data management for multiple medicinal products registered in numerous different regions involves significant effort, it can be a time consuming and costly process.
EXTEDO’s MPDmanager software solution simplifies the process of maintaining IDMP submissions, delivering a single source of truth for all IDMP data. By providing a repository for all registrations and enabling the electronic submission of data directly to the authorities, MPDmanager’s powerful medicinal product database enables you to efficiently fulfill regulatory requirements surrounding the management of product data.
- No technical IDMP knowledge needed to collect and maintain IDMP data
- Guided dictionary maintenance through standard regulatory activities
- Multiple internal and external users can maintain multiple medicinal products at the same time
- Assure data quality via business validation, technical validation and foureye principle
- Increased transparency and productivity via user friendly and modern interface
- Global IDMP and CFR Part 11 compliance
- Product dictionary provides a single source of truth for all your medicinal products
- Supports future demands such as multi-gateway functionality and data model changes
- Integration with EXTEDOsuite and other third party products to provide a total RIMS solution
- Reuse your data from source systems to improve data quality and save time
- Full system validation support reduces validation effort to a minimum
- Well established in operation management services, which takes over IT infrastructure services, application management services including maintenance of controlled vocabularies, pre-validated software releases and video tutorials on new features
Simplifying IDMP registration maintenance
MPDmanager’s clear and concise user interface is specifically designed to make data collection, maintenance and IDMP compliance straight forward. The integrated authoring guide provides you with the information needed to understand and collect your data. It also includes the knowledge to maintain activities with predictive regulatory activity selection. The system guides the user through each maintenance activity in a step-by-step mass update wizard until all changes have been executed. When you are ready to submit an update, MPDmanager’s builtin validation engine provides a quick and easy quality check to ensure that all changes remain compliant with ISO and other regional specifications.
MPDmanager is the perfect solution for any company size
Standalone IDMP software solution – for CROs, small to mid-sized corporations
As a standalone tool MPDmanager provides simple IDMP compliance for CROs and small to mid-sized corporations. Out-of-the-box, its capabilities enable you to efficiently submit and manage IDMP registrations with the EMA and other regional authorities.
While its easy-to-use interface allows you to browse data without requiring a detailed knowledge of the IDMP data model. Additionally, innovative dashboards and notifications provide you with upto-date information about the status of your registrations. MPDmanager also enables you to query live data through quick and advanced search forms, allowing your users to manage medicinal products efficiently.
Integrated in RIM and MDM – for medium to large-sized corporations
For larger corporations, MPDmanager can be implemented as part of an integrated Regulatory Information Management solution. Full multi-gateway functionality and automated communication between industry and authorities are supported and its plugin architecture enables you to connect to tools such as EXTEDO’s RImanager or Master Data Management (MDM) systems. This approach means that data can be reused, improving data quality and saving time.
Simplifying the move from XEVMPD to IDMP
MPDmanager is your perfect companion for handling the transition from XEVMPD to IDMP. The ability to access submission data without requiring a comprehensive understanding of every detail makes your transition smoother and ensures that your business continues to remain compliant into the future. EXTEDO MPDmanager provides Effortless Compliance™ with IDMP medicinal product data management regulations. It improves your data quality, increases operational efficiency, and delivers better-automated communication channels between your departments and with the authorities.
- Is our company able to meet the latest IDMP requirements?
This is the question that a lot of organizations are asking as they get ready for the transition from Extended Eudravigilance Medicinal Product Dictionary (XEVMPD) to Identification of Medicinal Products (IDMP). EXTEDO's services team is well-equipped with the knowledge and experience to help your organization transition painlessly from XEVMPD to IDMP.
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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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