By Niels Buch Leander, Managing Consultant, PhD
It has been announced that ISO IDMP will come into effect in Europe from July 2016, with other regions also adopting this stand- ard in the coming years. In most cases, Regulatory Affairs will be responsible for the ISO IDMP data submission as they were in the case of the submission of the XEVMPD data, often using the regulatory information man- agement system (RIMS) for the submission. At first sight it may seem obvious to extend the RIMS system to manage the ISO IDMP submission as well. However, you may need to reconsider.
While RIMS systems seemed suitable for collecting and submitting XEVMPD data in most cases, there are clear indications that a different IT strategy will have to be adopted for ISO IDMP. By analysing the ISO standards and the data sources in pharmaceutical companies, we see five important reasons why your RIMS system may not be suitable for managing your ISO IDMP data submission.
Building ISO IDMP into a RIMS system may jeopardise the stable operation of the RIMS system by necessitating further system updates in connection with changes in the ISO IDMP guidelines or HL7 messaging standards for gateway submission. Regulatory operations will have to live with the risk and cost of a RIMS system with more updates.
The data for XEVMPD resides mostly in the RIMS system and does not require auto- matic transfer of data from another system. However, the extensive set of data required for ISO IDMP will require data from a num- ber of other systems in the company, and it is not likely that all this data can be man- aged manually (or it will be too expensive to manage it manually). For example, ISO IDMP requires submission of Batch IDs; since these IDs are continuously created in the manufacturing systems, it is necessary to establish a regular data transfer from the manufacturing system.For these reasons, it seems unlikely that RIMS is a suitable candidate for managing and submitting ISO IDMP data by extending the current functionalities of the system. Rather, RIMS is more likely just one of several source systems for a central and independent ISO IDMP repository, taking into consideration the specific data architecture of the company.It should be stressed that the implementation guides for ISO IDMP have not yet been ap- proved and that it is too early to decide on a specific IT solution for IDMP. Nevertheless, it is not too early to settle on a strategy that takes into consideration the information sources in the company and the proposed information architecture for ISO IDMP.