SPORIFY
Driving Data-Centric Innovation for IDMP Readiness

For pharma and life sciences companies that market to the EU, it will soon be mandatory to comply with ISO standards for the Identification of Medicinal Products (IDMP), based on the four domains of master data in pharmaceutical regulatory processes: substance, product, organization, and referential (SPOR) data.

The introduction of IDMP signals an evolution within the industry, characterized by enhanced regulatory control, data quality and management, and interoperability between regulatory authorities, all contributing to better public health and safety.

To successfully navigate this transition, the organizations must significantly enhance their siloed product data-related processes spanning internal and external systems.

This is where SPORIFY takes the stage. It’s a one-stop data management and compliance solution that offers a streamlined pathway toward achieving IDMP readiness.

SPORIFY efficiently matches, maintains, synchronizes, and integrates SPOR data locked in disparate systems and establishes a consistent, enterprise-wide ‘golden record.’

By integrating with the Veeva Vault Regulatory Information Management (RIM) system and other enterprise platforms, the SPORIFY application enables seamless SPOR data synchronization that not just ensures IDMP compliance but opens up avenues for substantial process improvements and streamlined operations.

“IDMP’s emergence could be a watershed moment for pharmaceutical and life sciences companies. With solutions like SPORIFY, we can help pharma and life sciences companies navigate the journey toward this transformation more effortlessly,” says Gary Wilson, co-founder of CorrIT.

The SPORIFY Advantage

SPORIFY’s biggest advantage is it enables clients to start working with SPOR data immediately, without coding or extensive configuration, providing end-to-end support for their IDMP projects.

The application creates a localized system within its platform where it integrates with the source systems and links mapped data. Users have the flexibility to choose between extract and load integration or leverage SPORIFY’s builtin API to gain direct access to the latest SPOR data. This capability empowers users to monitor the real-time matching status of their data against the SPOR reference data. It is supported by SPORIFY’s multilingual mapping abilities that ensure accurate representation of data in various languages, a critical feature in a global business environment.

Another driving force behind SPORIFY’s effectiveness is its potential to boost data quality and enhance visibility. These enhancements trigger a ripple effect of efficiency improvements across a spectrum of departments, including regulatory, pharmacovigilance, manufacturing, and supply chain management. SPORIFY paves the way for building interoperable systems that automate data exchange and cleansing.

This streamlined approach ensures a reliable and consistent source of product information across global operations.

SPORIFY is recognized as an indispensable SPOR integration solution and offers the unique benefit of operating outside of existing RIM systems to act as a central interface with externally hosted controlled vocabularies.

It has a strong reputation and is trusted by industry professionals and regulators, as well as esteemed European project teams, such as the EU-SRS project. The project aimed to create a master substance list used in the pharmaceutical industry across European nations. SPORIFY played a critical role in cleaning and harmonizing substance-related data from many sources, making it instrumental in successfully creating a unified and reliable master substance list for Europe.

Maximizing Interoperability with SPORIFY’s Data Governance Module

A notable feature of SPORIFY is its data governance module. Its ability to review and approve changes in SPOR data before they are integrated into the Veeva Vault RIM system makes it a sought-after tool. The addition of this feature is a substantial leap forward as it empowers organizations to maintain compliance while adapting to the constant changes and updates in IDMP regulations.

The data governance module also anticipates and addresses the rising need for dedicated data stewards. A common issue many organizations face is the lack of skilled, in-house professionals who can manage SPOR data within their Veeva Vault RIM system. However, with SPORIFY’s data governance module, they can smoothly introduce data stewards into their workflows. The module aligns with their established policies and procedures, easing the integration of SPOR data management without extensive organizational changes.

SPORIFY’s mission is to create value for the entire life sciences industry by enhancing system interoperability through data integration from the U.S. FDA, Health Canada, and other regulators. Additional strategic integrations promote an open and efficient exchange of information within the life sciences industry worldwide, streamlining regulatory processes, ensuring compliance with evolving requirements, and unlocking new opportunities for growth and collaboration.

The Powerful Capabilities of SPORIFY in Action

“At its core, SPORIFY is an interoperator that recognizes the industry’s shift toward open standards. We are committed to supporting this movement by fostering an open ecosystem where the seamless exchange of data between systems is central to our mission,” says Wilson.

One of its clients, a multinational life sciences company, faced numerous hurdles while implementing the IDMP SPOR system. The existing SPOR interface was difficult to use and lacked collaborative features, hindering their ability to effectively interact with the SPOR master data systems. Manual searching and matching data between their source data and SPOR data proved laborious and time-consuming, leading to inefficiencies. Tracking changes within SPOR and maintaining data integrity also became overwhelming for the company.

Recognizing their specific challenges, SPORIFY emerged as the ideal solution. The centralized platform helped the client gather and work with internal data while promoting collaboration among team members. Its intuitive interface also surpassed the default SPOR interface’s limitations by offering automatic data matching and suggestion services. This eliminated the need for manual data searches and accelerated the process, saving valuable time and effort.
With SPORIFY’s tracking tools and notification features, the client could effortlessly stay updated with SPOR data changes. This real-time visibility also facilitated proactive decision-making, ensuring the company remained informed about any modifications in the SPOR data. As a result, data tracking was streamlined, communication and collaboration among team members improved, resource management became more efficient, and data mapping was simplified.

Maintaining a Stellar Reputation in the Industry

SPORIFY earned a prominent position in the IDMP space, thanks to the expertise and dedication of its team. With a core group of highly skilled software developers and deep involvement in the IDMP field, it possesses extensive knowledge and experience in navigating the complexities of the regulations.

The team’s active engagement with IDMP working groups, such as the SPOR Key User Group and IDMP Industry Association groups, is instrumental in establishing strong connections within the community. Staying connected with these associations and groups, they gain valuable insights into the evolving needs and emerging trends in the IDMP ecosystem. This ongoing involvement ensures its software development process remains attuned to the challenges faced by organizations striving for IDMP compliance.

As regulatory standards continue to evolve in the pharmaceutical industry, allocating resources for compliance with this ever-changing regulatory framework is paramount. In this regard, the SPORIFY solution is a comprehensive and versatile tool. Armed with advanced capabilities in data management, compliance, and workflow automation, SPORIFY empowers life sciences organizations to adeptly navigate the complexities of IDMP while unlocking the full potential of their SPOR data—serving as a catalyst for driving operational excellence in the pharmaceutical industry.