Most pharmaceutical companies are aware of ISO IDMP, which began in Europe on 1 July 2016 and with go-live of authorized products and substances in Q2 2019. Comprised of five ISO standards, the legislation is designed to standardize the identification of medicinal products. This will greatly improve pharmacovigilance across entire jurisdictions and reduce counterfeiting, ultimately keeping patients safer.
The standards will introduce complex interdependencies between the major IT systems in the pharmaceutical company, including safety, manufacturing, clinical, and regulatory systems. Hence, ISO IDMP will not only impact regulatory affairs, but the entire company. Data will need to be captured in every business unit and compiled and submitted to the authorities.
In order to accelerate your ISO IDMP journey and meet the deadline, we have defined and structured five phases to enable your timely compliance. Each phase can be conducted separately and independently of the other ones. However, going through all of the phases will ensure an effective and accelerated journey with clear roles and responsibilities supported by expert resources.
The first step in the ISO IDMP journey is to understand what needs to be done to achieve compliance and what the impact on your organization will be to achieve this.Based on an indepth understanding of the ISO standards and a set of standard tools, we identify stakeholders in your organization and, by means of workshops, map your source systems for ISO IDMP.For each ISO IDMP field, the source system field name, data format, and data owner is registered. Furthermore, external requirements, compatibility, and the impact of controlled vocabularies are registered.Based on this the data mapping and gap analysis, summaries are created.All findings are documented in a set of reports concluding on the maturity and necessary next steps, intended for management use.
Once the source systems and the data gap are identified, it is time to start preparing and enabling the business to deliver the ISO IDMP data. Based on a risk analysis determining the importance of each field described in the ISO standards, the preparatory steps are initiated.For the affected IT systems, plans for data alignment and system updates are created in order for them to be in a fit condition. For the data gap identified, the relevant stake holders are involved, and plans are made on how to build and maintain the data going forward.All activities are coordinated and aligned through the tobe IDMP enterprise architecture, which will function as a guiding star for the project.
The next step is to choose your software and vendor. Based on a standard ISO IDMP URS (user requirements specification), we offer an accelerated approach to developing the URS, saving you valuable time. Based on the outcome of the URS, a vendor assessment is offered to help you compare potential candidates.
NNIT can provide a unique package to accommodate your organizational implementation of IDMP. From setting up your ISO IDMP application, integrating the source systems, capturing data from unstructured sources to submission of the data. We provide a framework to support and govern the work streams of an IDMP program:
On top of this, you can benefit from a quality management and a test and validation kit, which can be customized to your needs. If you have specific requirements for validation, a full validation in accordance to your own QMS is possible.
Each work stream ensures that the different and vital parts of the IDMP program are coordinated and managed successfully. The source system integration is built on a data hub concept to introduce between your sources and IDMP application in order to tie your source systems together and interconnect, consolidate, transform and map information to controlled vocabularies before interfacing it with the ISO IDMP application. The IDMP repository is the implementation and setup of the application to hold and exchange the IDMP information with the authorities. Data capture is a stream to ensure that unstruc tured data will be handled and maintained in a structured format.
Article written: August 2017