ProductExpert is a fully configurable solution and a part of our Life Sciences Suite, which is built on a unique and innovative Integral by Design, Modular by Implementation™ architecture. The latter allows for easy and transparent mirroring of the required business processes together with their business entities in the system, using easy-to-apply configurations. It also allows for changes, extensions, and integrations, as well as automations and migrations, to be carried out in a matter of days as opposed to months.
This revolutionary design led to our modules being a market leader for XEVMPD in the EMA region, as more than 25% of all XEVPRMs submitted to EMA and nearly 50% of all XEVPRMs submitted using a vendor tool (outside of EMA’s WEB Trader tool) were submitted using this solution. Our clients manage between 5,000 – 100,000 EVMPD registrations.
With the combination of data model and the process-centric and role-based workspaces, our unique user interface enables a user-friendly way to manage data complexity. Combined with other powerful functionalities such as Change Control to manage the entity lifecycle, it offers a new generation of applications in this area. Many of our clients call it game changing!
COMPLIANCE BEYOND IDMP SPECIFICATIONS
SUPPORT FOR INVESTIGATIONAL PRODUCTS
ROLE-BASED, PROCESS-CENTRIC AND USER-FRIENDLY INTERFACE
SUPPORT FOR CONTROLLED VOCABULARIES AND MASTER DATA LIFECYCLE MANAGEMENT
RICH DATA AND BUSINESS RULE VALIDATION
EASY-MAINTAIN AND SCALE-IMPLEMENTED SOLUTION ACCORDING TO THE EVER-CHANGING BUSINESS AND REGULATORY REQUIREMENTS
Our clients call it game changing
ProductExpert supports the pragmatic IDMP introduction approach – our IDMPJourney™ methodology – which allows an iterative approach by:
MEET THE ISO IDMP IMPLEMENTATION DEADLINE
- Starting with the ISO IDMP standard for selected products
- Manage IDMP complexity in a user-friendly manner.
START SMALL AND PROGRESS TO FULL COMPLIANCE WITH IDMP
- Confirming integrations with Master Data and/or external systems
- Pragmatic IDMP assessment and implementation approach
- Discovering the level of required manual interactions
REDUCE COMPLEXITY. REUSE CONTENT AND INFORMATION.
- Designing and testing business processes using real data and solution
- One repository for all regulated content. One authoritative source of truth on product data
- Extending to other products and evolving to reflect emerging implementation guides
LIFE SCIENCES SOLUTIONS
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