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Five reasons why your RIMS system may not be suited for ISO IDMP

​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.

  1. The enormous amount of data and its  diverse sources

    Whereas data in the RIMS system makes up a substantial part of the XEVMPD data, ISO IDMP requires such an enormous amount of data that as little as 20-25% of ISO IDMP data will reside in the RIMS system, depending on how the pharma- ceutical company uses the RIMS system. From the ISO standards, it is clear that much data will reside in Clinical systems, Manufacturing systems, Labelling systems and Pharmacovigilance systems.
  2. RIMS is originally designed for another purpose

    RIMS systems are originally built to track registrations. Hence, the user interface is designed to allow a regulatory affairs manager to enter and review information pertaining to specific registrations and changes to those registrations. More and more functions have since been added to RIMS systems, but building ISO IDMP into  a RIMS system is not simple, as there is no clear way of presenting the extensive set  of ISO IDMP product data to the user in an application that was originally designed for a completely different purpose.

  3. There is a clash in the users of RIMS and IDMP submitters

    In connection with XEMVPD it has become clear that the employees who access RIMS to maintain a registration are not the same as those who maintain product data for submission to EMA. This tendency will be even stronger for ISO IDMP, and a lot of questions arise as a result:

     •  Why should RIMS data entry personnel have access to IDMP data? 
     •  Does your RIMS allow for structured editing, so that users working with IDMP data cannot edit certain data,
         such as the status of the registrations – and so that regulatory affairs managers cannot alter data purely used
         for ISO IDMP submission?
     •  The processes for updating registrations are often vulnerable, as data entry in a timely fashion and with high 
        data quality is pivotal. Could the extra IDMP informa- tion and the additional users potentially disturb these
        vulnerable processes?
     •  Finally, are the software licenses affected dramatically by an additional set of users in the application?
  4. Risky interdependencies between ISO IDMP and RIMS

    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.

  5. Data integrations are indispensable for IDMP

    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.

 

 

 

 

 

 

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