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.
FEATURES
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
EXCEPTIONAL CONFIGURABILITY
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
PRODUCTEXPERT BENEFITS
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
ProductExpert
ProductExpert is part of AMPLEXOR Life Sciences Suite. It is the first ISO IDMP compliant solution available on the market that enables users to meet IDMP related requirements.
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R&DExpert
R&DExpert is the most advanced and highly flexible solution, which enables users to efficiently manage R&D project and document management, including trial management. One environment. One authoritative source of truth.
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QualityExpert
QualityExpert is part of AMPLEXOR Life Sciences Suite. It enables users to manage all QA/QC processes and documents through a single user-friendly interface in one environment.
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RIMExpert
RIMExpert is part of AMPLEXOR Life Sciences Suite. It is a business intelligence tool designed to standardize the data management process across your company and product lifecycle.
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SubmissionExpert
SubmissionExpert is part of AMPLEXOR Life Sciences Suite. It is the most advanced solution that helps users create, compile, and manage regulatory submissions and publishing.
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