READY! and ISO IDMP

ISO IDMP standards are the cornerstone of READY!

READY! architecture fully supports the ISO IDMP data model, the new Controlled Vocabularies (SPOR) and forthcoming product submissions using HL7 standard.

READY! is easy to use, and all of the complexity of the ISO IDMP is hidden from the end user.

A user-friendly web interface helps to navigate and manage your product information in XEVMPD and ISO IDMP format simultaneously.

READY! comprises the following main elements related to enabling full support of ISO IDMP.

  • A web user interface and IDMP product database to manage and clean-up product information
  • Full support for SPOR, including interface to EMA API
  • An integration service for data retrieval, validation, and standardisation of product data from various data sources
  • A HL7 gateway for exchanging messages with regulatory authorities
  • Automatic validation of data prior to submitting
  • Tracking and management of all sent and received messages
  • Master Data Management

READY_for_IDMP-2017
READY! covers full support for ISO IDMP:

  • Full support for XEVMPD and the ISO IDMP standards
  • Automatic creation of XML messages for Article 57 in XEVMPD and ISO IDMP formats
  • An easy-to-use web interface that can track the status of XML messages
  • Automatic, two-step validation of product data and XML messages
  • Automatic submission of messages via built-in HL7 Gateway
  • Automatic error handling
  • Presentation of XML data into Word and PDF formats
  • The user-friendly web interface manually collects product information (for those companies without a backbone product database or tracking tools)
  • Drop-down lists are based on EMA’s controlled vocabularies (SPOR)
  • MEDDRA support
  • Strong change management capabilities (handling variations, updates, errors)
  • Support for product lifecycle management
  • Full reporting capabilities
  • Easy search
  • Export of data to Excel
  • Import of data from Excel
  • Import of XEVMPD messages (for migration purposes etc)
  • Export of XEVMPD messages
  • Import of IDMP/SPL messages (for migration purposes etc)
  • Export of IDMP/SPL messages
  • Security policy and access control
  • Handling of controlled vocabularies
  • Handling of user roles and groups
  • Life cycle management of medicinal product with regulatory status, version, and dates (change date, effective date, version date, etc.)
  • Automatic alerts

READY! supports integration, retrieval, cleaning, re-mapping, validation, and standardisation (formatting) of source data according to ISO IDMP and usage of relevant Controlled Vocabularies (CVs).

READY! can be integrated with the other IT systems:

  • Existing product databases
  • Document Management Systems, including MS Sharepoint and EMC Documentum
  • SAP, Oracle, Navision, and other ERP systems
  • Various tracking tools and RIM solutions
  • MS Excel-based data lists

The following integration interfaces are available for secure exchange of information:

  • Web services
    (Over plain HTTP or by using an SSL connection)
  • FTP and SFTP interfaces
    (Also, there is an option to use XLS message format)

READY! translates the received product information into the format defined by the ISO IDMP standard, performs automatic validation, and sends the valid messages to the EMA ISO IDMP Gateway when applicable.

Messages are automatically validated against the latest Controlled Vocabularies (SPOR) to ensure the accuracy and quality of medicinal product information prior to submission.

This approach simplifies implementation of subsequent changes to the EMA ISO IDMP XML Schema or business rules, and helps avoid unnecessary changes and re-validation of the interfaces between internal IT systems and the READY! solutions.

Our experience with the xEVMPD implementation projects and membership in the IDMP Implementation Task Force has enabled us to create the optimal solution for the pharmaceutical industry.

 

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