Pharmaceutical regulations are tightening and to keep up with such a complex regulatory landscape pharma companies must rely on a robust Enterprise Data Management system.
The European Medicines Agency (EMA) requires companies that produce and market authorized medications within the EU and European Economic Area to comply with the ISO Medicinal Identification (IDMP) standard. One of the main goals of IDMP is to guarantee data protection, privacy and confidentiality. It is required to store all information about substances, dosages, units of measurement, packaging and products and standardize the data model for registration and management.
Pharmaceutical companies must implement interactive support interfaces for publishing and consulting data on demand to support the entire product life cycle. It is also necessary to develop a process of data governance for the entire life cycle with precise assignment of roles and responsibilities. Adaptation to legislation also goes hand in hand with the development of services to support master registrations, which guarantee data maintenance and access by customer service with a clear and timely data transmission to all parties involved in the production process .
In such a challenging context, Irion, with strong experience developing data management solutions in tightly regulated markets is helping pharma companies to implement the right approach to comply with IDMP.
An example of a widespread problem is represented by how companies in the industry present EMEA data on their products: formats are different, data quality is poor and lack of appropriate data and analytical information. Due to the exponential increase in the number of processes and business systems that have occurred in recent years, duplication of data between systems is recorded and their management is isolated and not integrated: as is easy to foresee, it results in a reduction of data quality and increased inefficiencies.
To solve these problems, the Data Virtualization and Data Federation capabilities of our platform are extremely helpful enabling quick and easy data aggregation from different sources quickly and easily. Using a powerful rule engine also enables data classification and reconciliation for certification checks, then rules can be documented in natural language for better understanding. In addition, the entire process can be recorded and documented in a non-modifiable manner for audit and compliance purposes.