Sign In / Register
Achieve continuous worldwide UDI Compliance
UDI Platform
byprojektraum36 GmbH & Co. KG
Solution Types
Applications
Works with
SAP Cloud Platform
Benefits and Features
Benefits
Benefit from a Managed Service
UDI is going to be an ongoing process in your company, as more regulatory authorities will issue UDI regulations. You will have to handle them together with upcoming changes in existing UDI databases - that´s why we deliver UDI content continuously to ensure a compliant state.
Expand to other countries
Manage your UDI compliance on a single UDI Platform - start to ensure compliance with FDA and EUDAMED and extend to other countries/regions with our Content Packages based on our multi-agency approach.
Integrate to your SAP landscape
Benefit from a native integration of the regulatory data on the UDI Platform solution with your operative ERP data in your hybrid SAP Landscape. Whether SAP ERP, MDG or S/4 HANA - the UDI Platform integrates seamlessly into your existing SAP-managed product data.
Stay compliant with the UDI Platform
The UDI Platform offers the strategic answer to your UDI challenge. It allows handling multiple regulatory authorities (“Multi-Agency-Capability”), integrates into existing processes and workflows and leverages existing Product Master Data in your SAP Systems - fast, flexible and easy to use.
Operated and natively built on SAP Cloud Platform
Natively built and operated on the SAP Cloud Platform, the UDI Platform integrates seamlessly into your existing SAP System Landscape, allowing to combine operational processes with regulatory processes.
Add Content Packages for worldwide compliance
Content Packages are the centerpiece of the UDI Platform. They enable you to cover the requirements of different regulatory authorities, containing the specific data model, data validation rules and the complete handling of exchanging data with the authorities to achieve global UDI compliance.
Benefit from a native SAP Integration
Benefit from a native integration of the regulatory data on the UDI Platform solution with your operative ERP data in your hybrid SAP Landscape. Whether SAP ERP, MDG or S/4 HANA - the UDI Platform integrates seamlessly into your existing SAP-managed product data.
Plans and Pricing
hand with checkmark
All Plans include
Managed UDI Platform
Enhanceable Rules Framework
Customizable Maintenance Processes based on Workflows
Highly customizable User Interfaces
Integration into existing on-premise Processes
Re-Use of existing Master Data
Advanced Reporting for Data and Submission status
UDI Platform Base Package
USD
1
.00
Per Month
UDI Platform Base Package
UDI Platform Base Backage. Your start into the UDI-Platform - get familiar with the platform and its features.
Please contact us for a personal quote.
Includes unlimited User
FDA Content Package
Price upon request
FDA Content Package
This package contains the pre-configured content to exchange data with FDA GUDID database
GUDID Data Model with all necessary attributes
Includes all validation and changeability rules
Grace Period-handling
Unlocking Feature
Submission Handling
Reporting
Includes unlimited User
EUDAMED Content Package
Price upon request
EUDAMED Content Package
Enhancement Package covering EUDAMED contents
EUDAMED Data Model and all necessary attributes
Validation Rules
Submission handling
Reporting
Availability: dependent on final EUDAMED implementation Guide
Includes unlimited User
Technical Information
The information contained in this section is provided by the publisher.
Solution Types
  • Applications
Works with
  • SAP Cloud Platform
Publisher
projektraum36 GmbH & Co. KG
p36 delivers highly innovative Software-as-a-Service solutions for the Life Sciences industry by combining outstanding SAP technology know-how with special expertise in regulatory topics in the Life Sciences - making p36 the perfect partner to support ...
Publisher Website