The pharmaceutical industry is under high pressure to meet strict regulatory guidelines, particularly the Identification of Medicinal Products (IDMP) guidelines. These guidelines are established by the International Organization for Standardization (ISO) to ensure consistent and accurate identification of medicinal products, enhancing patient safety and facilitating regulatory compliance. 

However, achieving IDMP compliance is not easy, as it comes with numerous challenges, including poor data quality, which can affect annual revenue and the organization’s reputation. Failure to do so not only affects the regulatory standing but also poses risks to patient safety and operational efficiency. 

Learn more about IDMP compliance and how Boomi iPaaS helps to address all its challenges with Boomi MDH and integration capabilities. 

What is IDMP Compliance?

The International Organization for Standardization (ISO) has developed the Identification of Medicinal Products (IDMP) standards, which outline standardized definitions for identifying and describing medicinal products intended for human use. These standards are designed to reliably and consistently streamline the exchange of medicinal product information.

In the pharmaceutical industry, a single finished product can take on three distinct forms:

• The pharmaceutical product as administered
• The authorized medical product, and
• The packaged product that ships to market.

This illustrates just one aspect of the complexity; hence, there is a need for a common language throughout the lifecycle of a medicinal product.

Standards of IDMP

IDMP consists of five distinct standards, each defining concepts, data elements, and their structural relationships.

• Substance Identification (ISO 11238)
  Defines substances that constitute a medicinal product by their main, general characteristics.
• Medicinal Product Identification (ISO 11615)
  Data elements that identify and characterize a medicinal product include the product name (authorized by regulatory agency), clinical particulars, pharmaceutical product (substance, dosage form, route of administration), medicinal product packaging, marketing authorization, manufacturer/establishment, etc.
• Pharmaceutical Product Identifier (ISO 11616)
  Data elements that uniquely associate medical products with the same or similar pharmaceutical composition based on the following data elements: substance(s), strength(s) (units of measurement/presentation), reference strength(s), and dosage form.
• Dosage Form and Route of Administration (ISO 11239)
  Data elements that provide information on pharmaceutical dose forms, units of presentation, routes of administration and packaging
• Units of Measurement (ISO 11240)
  Data elements and structures for unique identification and exchange of units of measurement.

The European Medicines Agency (EMA) is implementing the ISO IDMP standards for the identification of medicinal products in a phased programme, based on the four domains of master data in pharmaceutical regulatory processes: substance, product, organization and referential (SPOR) data.

Challenges to IDMP Compliance:

• Complex data & processes: Pharmaceutical companies often handle extensive datasets spread across diverse systems, departments, and locations. This leads to the formation of data silos and inconsistencies. Achieving effective data management necessitates coordination and collaboration among regulatory authorities, various departments, and stakeholders.
• Technical Obstacles: Adopting IDMP standards entails the harmonization and standardization of data across various databases and systems. This task can prove particularly daunting, especially for organizations utilizing legacy systems or possessing diverse data structures. Overcoming these technical hurdles and ensuring seamless interoperability may require a significant amount of time and effort.
• Regulatory Constraints: Regulatory requirements evolve, necessitating continuous updates and adaptations to ensure ongoing compliance. Additionally, different regulatory authorities have different approaches to implementing IDMP standards.

Why is Boomi Master Data Hub the solution for IDMP?

Master Data Management serves as the foundation for achieving IDMP compliance by ensuring consistent, accurate, and governed medicinal product data across all systems. 

Boomi Master Data Hub unifies fragmented datasets, standardizes formats, and maintains data integrity through powerful integration, quality management, and governance capabilities. Boomi’s data management capabilities simplify regulatory reporting, enhance transparency, and accelerate compliance as per the latest standards, making Boomi iPaaS the right solution for IDMP compliance. 

1. Data Standardization

A medicinal product’s data is composed of datasets from various departments, including regulatory, finance, quality, supply chain, and others. In addition to a large number of attributes that define a product, the same attribute can take multiple forms depending on its source.

Standardization ensures that data is formatted consistently, making it easier to understand, compare, and integrate across various systems or organizations.

Boomi Master Data Hub (MDH) harmonizes disparate datasets by seamlessly integrating with different data sources, enabling mapping and reconciling differences in terminology, classifications, or data models to establish common standards. By leveraging Boomi’s unified data management framework, organizations can ensure that product data is aligned, complete, and ready for IDMP-compliant submissions.

2. Data Quality Management

Product data can be available in structured and unstructured forms. Data may be entered manually or read from documents using Optical Character Recognition (OCR) technology. Multiple ingestion methods can lead to data quality issues.

Boomi Master Data Hub incorporates data quality tools and processes to cleanse, enrich, and validate data, ensuring its accuracy, completeness, and conformity to regulatory standards.

By maintaining high-quality, trusted data across all connected systems, Boomi’s MDM platform empowers pharmaceutical companies to enhance compliance confidence and streamline regulatory submissions.

3. Version Control and Audit Trail

Medicinal product data changes and updates throughout its lifecycle, and not all attributes that define a product will be readily available on day 1. For example, the license number for a product can vary by country of registration and will be available only after the product is registered.

Hence, maintaining an audit trail of all changes and updates to product data is essential for regulatory compliance.

Master Data Hub tracks changes to data elements, maintains version control, and provides an audit trail, facilitating compliance documentation and regulatory reporting.

4. Data Stewardship & Data Governance

IDMP mandates meticulous data management for medicinal products. Therefore, efficient data governance is crucial for maintaining regulatory compliance, ensuring data integrity, safeguarding security, and facilitating seamless information exchange.

Similarly, to ensure proactive management and oversight of an organization’s data assets, data stewardship will be critical.

Boomi Master Data Management provides a centralized platform for assigning data stewardship roles and responsibilities, facilitating oversight of data quality and integrity, and enabling tools to enforce data standards, validate data accuracy, and resolve data conflicts.

With Boomi’s governance capabilities, pharma organizations can create a culture of accountability, ensuring all data used in IDMP submissions is accurate, traceable, and regulatory-ready.

5. Single Source of Truth

IDMP compliance necessitates accurate and complete reporting of product data to regulatory authorities. Duplicacy can lead to discrepancies in regulatory submissions, potentially resulting in compliance issues, fines, or regulatory penalties.

Inaccurate or inconsistent product data resulting from duplication can have profound implications for patient safety and public health.

A core capability of Boomi’s Master Data Management (MDM) solution is to create a single source of truth for all master data. Boomi MDH consolidates data from multiple systems into a unified, authoritative repository, ensuring consistency and accuracy across domains.

This “golden record” approach eliminates redundancy, reduces compliance risk, and ensures that every department, from R&D to regulatory,  works with the same trusted data.

Why Choose Boomi for Veeva Vault Integrations?

Veeva is a popular cloud-based software solution designed for the life sciences industry. Pharmaceutical and other life sciences companies can use Veeva to leverage the benefits of modern cloud-based architectures and mobile applications for their business functions and regulatory compliance. 

Boomi’s dedicated connector for Veeva Vault uses the Vault APIs for full data access and to simplify connectivity between Veeva Vault and other applications. This connector eliminates the need for custom coding, which is prone to errors and time-consuming. By using Boomi iPaaS, you can quickly integrate systems and set up automated processes to make the most of your data stored in Veeva Vault. 

• Low-code Connectivity – Veeva Vault is part of Boomi’s low-code development environment. The easy-to-use drag-and-drop graphical interface eliminates the need for custom coding or following traditional integration approaches. Pharma companies using Veeva Vault can easily integrate and automate processes. 

• Scalable and Secure Connectivity – Companies can leverage and deploy their Boomi integrations across any environment, on-premises, cloud, or hybrid—using the Boomi Veeva Vault connector. Also, comply with rigorous security requirements and industry standards, such as HIPAA. 

• Acceleration with Automation – Veeva customers can use Boomi to build automated workflows by using the Veeva Vault data. Boomi’s AI-powered development tools and process templates accelerate the entire process. 

Key Advantages of Boomi for Veeva Vault Connector

The Boomi Veeva Vault Connector not only connects Veeva with other systems but also leverages the full capabilities of the iPaaS platform to automate workflows, accelerate data exchange, and improve regulatory compliance. 

1. Streamlined Connectivity – The Boomi Veeva Vault connector simplifies connectivity between systems and applications by leveraging the latest Vault APIs for comprehensive data access. This direct connectivity reduces the dependency on manual coding. 
2. Low-Code Development – Boomi is known for its low-code capabilities, enabling researchers and business stakeholders to create and deploy integrations quickly. There is no need for extensive coding either. 
3. Flexible and Secure – The Boomi connector for Veeva Vault is flexible, allowing customers to configure integrations across on-premises, cloud, and hybrid environments, with support for various regulatory compliance standards, such as HIPAA. 
4. Automation for Business Process – Veeva users can leverage other capabilities of the Boomi Enterprise Platform, such as workflow automation using Veeva Vault data. AI-powered development tools, process templates, and low-code development accelerate automation.

Conclusion

IDMP compliance is no longer an option for pharmaceutical companies, but a critical regulatory requirement that ensures patient safety, data integrity, and operational efficiency. It poses numerous challenges, such as fragmented data, legacy systems, and evolving regulatory expectations.

Boomi’s Master Data Hub practices and integration capabilities help pharma companies to harmonize, cleanse, and standardize medicinal product data across all departments. 

NeosAlpha leverages Boomi’s Master Data Management (MDM) practices and integration platforms, to harmonize, cleanse, and standardize medicinal product data for your organization. The Boomi Veeva Vault Connector further accelerates automation, ensures regulatory adherence, and provides a single source of truth for accurate reporting.

In an era where non-compliance can lead to substantial fines, reputational damage, and patient risk, adopting intelligent, automated, and scalable solutions is essential. Pharmaceutical companies that proactively invest in data management and integration are best positioned to meet IDMP standards efficiently while enhancing overall business agility.

Frequently Asked Questions

1. What is the IDMP data standard?

Identification of Medicinal Products (IDMP) is a suite of ISO standards that define coded data elements for uniquely identifying and describing medicinal substances, products, packaging, and related regulatory information. IDMP ensures the consistent exchange of medicinal product information across all vendors, manufacturers, and other stakeholders. 

2. What are the challenges of IDMP?

Pharma businesses often face diverse data silos, inconsistent formats, legacy systems, and significant gaps in harmonizing information across departments. Interoperability difficulties and technical overhead add further complexity. However, all these can be easily addressed by platforms like Bomi. To get tailored solutions, connect with our Boomi experts.

3. What is the guidance of IDMP?

Regulators issue implementation guides and messaging standards to support how to apply ISO IDMP elements in submissions, e.g., via SPOR (Substance, Product, Organisation, Referential) frameworks. The guidance emphasizes phased adoption, consistent terminology, version control, and alignment with regulatory messaging formats. 

4. Why is Boomi the right solution for IDMP Compliance?

Boomi iPaaS is known for its integration and data management capabilities. Boomi Master Data Hub provides a unified platform for cleansing, standardizing, and harmonizing data from multiple sources. Additionally, Boomi has dedicated a Veeva Vault Connector (Veeva Vault is a cloud-based content and data management platform built specifically for use in the Healthcare industry).

5. How can pharmaceutical companies streamline data harmonization to meet IDMP standards?

Pharmaceutical companies can use the Boomi Master Data Hub to streamline data harmonization by consolidating product, substance, and organization data from multiple sources into a single, standardized repository. Boomi MDH features, such as automated data validation and mapping, ensure compliance with ISO IDMP formats.