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LifeSphere® IDMP

Complete ISO IDMP compliant software solution

LifeSphere® IDMP

Complete ISO IDMP compliant software solution

Key Benefits


  • Allows the import and cleansing of raw data from different sources or can work with an master data management (MDM) solution
  • Uses integration module or natural language processing (NLP) and optical character recognition (OCR) capabilities to collect information from different systems into a central hub
  • Supports workflow-driven process for enrichment and verification of compiled information
  • Acts as the central source of product information throughout the organization
  • Provides webservices and standard connectors to integrate with third-party systems through open architecture

LifeSphere® IDMP – A Complete ISO IDMP Software Solution

LifeSphere IDMP provides a complete ISO IDMP software solution to address the challenges from implementation of Identification of Medicinal Products (IDMP) standards. A multi-tenant cloud-based solution, LifeSphere IDMP enables companies to achieve compliance and leverage their investments to realize multiple business benefits.

Using a flexible interface layer, companies can collect information from different sources, and consolidate, map and transform that information before filing it into a central repository that conforms to the complete ISO IDMP model for managing product information. Users can review, enrich and verify the data before submission to the regulatory authorities.

For the submission process, LifeSphere IDMP relies on the proven technology used for safety (E2B) and xEVMPD electronic submissions. With an integrated submissions gateway, the IDMP solution handles the submission and management of the IDMP IDs, which is critical to ensure the global use of the IDMP standard.

LifeSphere® IDMP – A Complete ISO IDMP Software Solution

LifeSphere IDMP provides a complete ISO IDMP software solution to address the challenges from implementation of Identification of Medicinal Products (IDMP) standards. A multi-tenant cloud-based solution, LifeSphere IDMP enables companies to achieve compliance and leverage their investments to realize multiple business benefits.

Using a flexible interface layer, companies can collect information from different sources, and consolidate, map and transform that information before filing it into a central repository that conforms to the complete ISO IDMP model for managing product information. Users can review, enrich and verify the data before submission to the regulatory authorities.

For the submission process, LifeSphere IDMP relies on the proven technology used for safety (E2B) and xEVMPD electronic submissions. With an integrated submissions gateway, the IDMP solution handles the submission and management of the IDMP IDs, which is critical to ensure the global use of the IDMP standard.

Background

As a continuation of the current xEVMPD mandate (Article 57), the European Medicines Agency (EMA) is in the process of defining and implementing new standards based on the ISO standard for the identification of medicinal products (ISO IDMP). While primarily a regulatory obligation to improve patient safety, the new standard also provides the life sciences industry with a unique opportunity to standardize product data, drive operational efficiency and compliance throughout the organization.

The challenge for the industry however is more than the evolution of xEVMPD. The data captured in the ISO IDMP standard is much greater and would require the involvement from not only the regulatory department but also others such as manufacturing, label management and clinical amongst others. Companies are beginning to understand that the diverse information which exists in their organization to support the ISO IDMP standard is only available on paper or non-structured formats like PDF. As such, the solution required is not only about regulatory compliant submissions but also of data standardization and consolidation within their organization.

Although the deadlines for the compliance mandate are not yet finalized, it is clear that with the size of the challenge at hand companies need to start working on this now.

Key Benefits
  • Allows the import and cleansing of raw data from different sources or can work with an master data management (MDM) solution
  • Uses integration module or natural language processing (NLP) and optical character recognition (OCR) capabilities to collect information from different systems into a central hub
  • Supports workflow-driven process for enrichment and verification of compiled information
  • Acts as the central source of product information throughout the organization
  • Provides web services and standard connectors to integrate with third-party systems through open architecture