ISO IDMP comes into effect in Europe in 2019. Comprising five ISO standards, the legislation is designed to standardize the identification of medicinal products. NNIT has defined five phases toward ISO IDMP compliance. Phase I and II look at the business impact and data gap analysis. Phase III looks at the requirements and components needed in your IDMP solution and uses this to identify the criteria for vendor selection.
NNIT can help you accelerate the specification of the user requirements for your IDMP Solution (URS), providing a detailed description of the solution to be delivered by the vendor(s). The scope of the URS is preferably a solution based on configurable standard components that can be integrated into the existing infrastructure and business processes. The outlined solution should enable your organization to identify, manage, submit, and track IDMP data sets as defined in the five ISO Standards.
Based on the outcome of the URS, a vendor assessment is offered to help you compare potential candidates. A combination of an architecture vision and the user requirements will drive the selection criteria in combination with NNITs knowledge about IDMP vendors and the maturity of their products.
In phase III, we look closer at the identified data sources and how these can be merged into the IDMP Solution. How is data physically stored and is it technically feasible to transform the data into IDMP conformance? NNIT provides templates and assists in discovering and documenting the business keys that link data across IT systems and business areas. Which process steps are currently approving or releasing data and can these be found in the source systems and used to deliver the data to the IDMP solution? Based on the decisions for filling the data gap identified in phase II, the required data remediation workflows can be described and utilized to further specify the solution. NNIT can assist you in identifying and documenting the user requirements for your IDMP solution and use this to drive the vendor selection. Our specialist knowledge within ISO IDMP combined with many years of experience with IT in the GxP domain ensures a solid foundation.