ProductExpert

MEET THE ISO IDMP
IMPLEMENTATION DEADLINE.

Manage IDMP complexity in a user-friendly manner.

START SMALL AND PROGRESS TO FULL COMPLIANCE WITH IDMP.
Pragmatic IDMP assessment and implementation approach.

REDUCE COMPLEXITY. REUSE CONTENT AND INFORMATION.
One repository for all regulated content. One authoritative source of truth on product data.

ProductExpert is the first ISO IDMP compliant solution available on the market, which enables users to meet IDMP related requirements. One time data entry. One source of truth.

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 ProductExpert 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.

ProductExpert supports the pragmatic IDMP introduction approach – our IDMPJourney™ methodology – which allows an iterative approach by:

  1. Starting with the ISO IDMP standard for selected products
  2. Confirming integrations with Master Data and/or external systems
  3. Discovering the level of required manual interactions
  4. Designing and testing business processes using real data and solution
  5. Extending to other products and evolving to reflect emerging implementation guides

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 CONTROLLED VOCABULARIES AND MASTER DATA LIFECYCLE MANAGEMENT

 

SUPPORT FOR INVESTIGATIONAL PRODUCTS

 

RICH DATA AND BUSINESS RULE VALIDATION

 

EXCEPTIONAL CONFIGURABILITY


EASY-MAINTAIN AND SCALE-IMPLEMENTED SOLUTION ACCORDING TO THE EVER-CHANGING BUSINESS AND REGULATORY REQUIREMENTS


ROLE-BASED, PROCESS-CENTRIC AND USER-FRIENDLY INTERFACE

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