ISO IDMP began in Europe on 1 July 2016 with enforcement of authorized products and substances in Q2 2019. Comprised of five ISO standards, the legislation is designed to standardize the identification of medicinal products. NNIT has defined five phases towards ISO IDMP compliance. Phase I consists of a business impact analysis. Following the identification of the source systems and the data gap as de-scribed in phase I, the business can now start preparing and enabling the business to deliver ISO IDMP data.
The scope is determined based on a risk analysis evaluating each field and classifying them:
Category 1 and 2 fields are chosen for further work.
Based on the risk analysis and a to-be IDMP reference enterprise architecture, the changes to source systems and actions for filling the data gap are planned.The reference architecture is used as a guiding star for the project to ensure that all sources work towards the same goal, avoiding sub-opti-mization, and ensuring appropriate data governance.
For each source system identified the necessary steps to get the system ready for IDMP are outlined and consolidated. The respective owners must understand what data is needed, for what purpose, in which format and when. Outline a strategy for fields in need of clean-up or alignment before they are fit for submission.
The responsibility to remedy the identified IDMP data gap must be delegated. If fields are pooled in logical groups, the department handling the data should be identified and a data owner appointed. The scope of the data must be fully understood and a strategy on how to close the gap must be outlined. Either the data is added to an existing system, the IDMP system or a complete new application may be build. For singular fields which does not pool, it must be identified where these will fit in the applica-tion landscape, and necessary system changes initiated. NNIT can assist preparing your business for ISO IDMP. Our specialist knowledge on ISO IDMP combined with many years of experience with IT in the GxP domain ensures a solid foundation.