Identification of Medicinal Products (IDMP)

IDMP

To simplify the exchange of information between regulatory authorities worldwide and to support healthcare authorities in the development of electronic health records, the International Organization for Standardization (ISO) has developed the Identification of Medicinal Products (IDMP)standards. The goal of IDMP is to expand the safety monitoring of medicines through sharing of data across classes of medicines and therapeutic areas.

For IDMP compliance, manufacturers need to implement the ISO standards for how all data is captured, transformed, governed and reported.

Current IDMP Challenges

  • Much of the required data exists in unstructured documents so document parsing capabilities will likely be needed.
  • Master Data Management (MDM) will be necessary since data required for IDMP is distributed across multiple departments and systems within R&D, manufacturing and regulatory affairs.
  • Companies should plan for cross-functional process changes and expanded governance.
  • Managing product data centrally (using a central repository of product information with controlled vocabularies) will produce a variety of business benefits.

Benefits of the Sparta IDMP Management Solution

Sparta helps manage regulatory business process workflows of the IDMP submission including:

  • Review, approve, submit, track & exchange product information.
  • Handle individual Case Safety Reports (ICSRs) and data trending.
  • Status oversight & quality control of IDMP records throughout the building and submission processes.
  • Provide version control and information retention.

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