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Regulatory Compliance for Life Sciences

Mitigate risk and reduce the effort required to comply with increasingly complex regulations like UDI and IDMP through complete data management.

Regulators in the United States, Europe, and elsewhere are increasingly asking for information that lies outside the control of the regulatory affairs department. Unique Device Identification (UDI) and Identification of Medicinal Products (IDMP) are two examples where significant amount of data is required from operations and systems in R&D, production, and supply chain, among other areas. These new regulations are overlapping with existing regulations, requiring the same data values to be submitted for different regulations.

Regulators themselves are improving their data management capabilities with the European Medicines Agency publishing information on their Master Data Management Roadmap for four domains: Substance, Product, Organisation, and Referential data. These improvements imply that the regulators will be more advanced in data management than many pharmaceutical organizations, who do not have a tradition of data management across divisions, departments, and systems.

Without good data management, pharmaceutical companies are increasing their risk of non-compliance and audit by not being able to meet the key challenges of increased regulation:

  • Organizational: Requiring participation from data experts in multiple departments
  • Technical: Discover, collect, and consolidate data from multiple source systems
  • Coordination: Synchronize between multiple regulations and internal processes

To add complexity, the data required for compliance is undergoing continuous change as formulation (medicines), design (devices), production, packaging, and supply chains are constantly improved. This all contributes to the ballooning cost of compliance. The president of global R&D at Sanofi estimated that 20 percent of the R&D budget is spent on managing requirements from different regulatory agencies.

To add complexity, the data required for compliance is undergoing continuous change as formulation (medicines), design (devices), production, packaging, and supply chains are constantly improved. This all contributes to the ballooning cost of compliance. The president of global R&D at Sanofi estimated that 20 percent of the R&D budget is spent on managing requirements from different regulatory agencies.

A master data management (MDM) approach to compliance introduces a data governance framework in order to maintain control over all data, especially that required by regulators. This approach brings the following benefits:

  • Workflows to involve data subject matter experts across the organization
  • Reduce risk through data consistency and lineage tracking
  • Unlimited reuse of data across the organization for measurable business value
  • Complete data management including complex hierarchies and relationships
  • Start small and grow with increasing requirements and capabilities

Informatica supports a complete MDM approach to compliance through its world-class MDM, Data Integration, and Data Quality products.

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