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Are you ready for IDMP?
3rd March 2015
Duncan Hall, CEO Triumph
With the ISO IDMP regulations now expected to be in place in less than 18 months time, companies wishing to market products in ICH regions need to have answers to three key questions in the very near future……
1 - What will it take to be ISO IDMP compliant?
2 - How close are we to being compliant?
3 - What is our strategy for bridging the compliance gap?
Let’s take a look at each of those in a little more detail…
1. Whilst the exact details of ISO IDMP have not yet been released, the EMA have agreed on the five ISO standards which IDMP will be derived from (11615, 11616, 11238, 11239 and 11240). How these standards apply to each company is dependent on the type of products that company is producing. Triumph are able to advise on which elements of which standards are likely to impact any given company.
2. Most companies faced with ISO IDMP compliance needs are evolving from current compliance with the XEVMPD standards. This is a good starting place for your gap analysis. Those companies who have a well executed XEVMPD strategy will undoubtedly be in a better position for the leap to IDMP compliance. IDMP is going to add challenges both in the additional data fields that are going to be required by IDMP as well as the need to express relationships between them. The questions that need to be asked of the requirements defined at question 1 include:
3. Once you have answers to questions 1 and 2, you will be in a much better position to consider your IDMP compliance strategy. The main approaches we are seeing in the industry are
(1) implementation or upgrade of a regulatory information management system (RIMS)
(2) Implementation of a data warehouse / data mart.
(3) Master data management (MDM).
The reality for many companies is that the optimal solution will be a combination of 2 or three of these approaches depending on their current regulatory infrastructure and of course the answers to questions 1 and 2.
Given the past experience of many companies taking 12-18 months to implement their XEVMPD compliance strategies, our advice is to start answering these three question now. If you would like any further information or advice on how to approach planning for IDMP compliance please feel free to contact us at firstname.lastname@example.org
As ISO IDMP compliance is such an industry hot topic right now, Triumph will be publishing more work and case studies in this area over the next six months, so please keep an eye on our website.
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