Business Asking IT to Install MDM: Will IDMP make it happen?
MDM for years has been a technology struggling for acceptance. Not for any technical reason, or in fact any sound business reason. Quite simply, in many cases the business people cannot attribute value delivery directly to MDM, so MDM projects can be rated as ‘low priority’. Although the tide is changing, many business people still need help in drawing a direct correlation between Master Data Management as a concept and a tool, and measurable business value. In my experience having business people actively asking for a MDM project is a rare occurrence. This should change as the value of MDM is becoming clearer, it is certainly gaining acceptance in principle that MDM will deliver value. Perhaps this change is not too far off – the introduction of Identification of Medicinal Products (IDMP) regulation in Europe may be a turning point.
At the DIA conference in Berlin this month, Frits Stulp of Mesa Arch Consulting suggested that IDMP could get the business asking for MDM. After looking at the requirements for IDMP compliance for approximately a year, his conclusion from a business point of view is that MDM has a key role to play in IDMP compliance. A recent press release by Andrew Marr, an IDMP and XEVMPD expert and specialist consultant, also shows support for MDM being ‘an advantageous thing to do’ for IDMP compliance. A previous blog outlined my thoughts on why MDM can turn regulatory compliance into an opportunity, instead of a cost. It seems that others are now seeing this opportunity too.
So why will IDMP enable the business (primarily regulatory affairs) to come to the conclusion that they need MDM? At its heart, IDMP is a pharmacovigilance initiative which has a goal to uniquely identify all medicines globally, and have rapid access to the details of the medicine’s attributes. If implemented in its ideal state, IDMP will deliver a single, accurate and trusted version of a medicinal product which can be used for multiple analytical and procedural purposes. This is exactly what MDM is designed to do.
Here is a summary of the key reasons why an MDM-based approach to IDMP is such a good fit.
1. IDMP is a data Consolidation effort; MDM enables data discovery & consolidation
- IDMP will probably need to populate between 150 to 300 attributes per medicine
- These attributes will be held in 10 to 13 systems, per product.
- MDM (especially with close coupling to Data Integration) can easily discover and collect this data.
2. IDMP requires cross-referencing; MDM has cross-referencing and cleansing as key process steps.
- Consolidating data from multiple systems normally means dealing with multiple identifiers per product.
- Different entities must be linked to each other to build relationships within the IDMP model.
- MDM allows for complex models catering for multiple identifiers and relationships between entities.
3. IDMP submissions must ensure the correct value of an attribute is submitted; MDM has strong capabilities to resolve different attribute values.
- Many attributes will exist in more than one of the 10 to 13 source systems
- Without strong data governance, these values can (and probably will be) different.
- MDM can set rules for determining the ‘golden source’ for each attribute, and then track the history of these values used for submission.
4. IDMP is a translation effort; MDM is designed to translate
- Submission will need to be within a defined vocabulary or set of reference data
- Different regulators may opt for different vocabularies, in addition to the internal set of reference data.
- MDM can hold multiple values/vocabularies for entities, depending on context.
5. IDMP is a large co-ordination effort; MDM enables governance and is generally associated with higher data consistency and quality throughout an organisation.
- The IDMP scope is broad, so attributes required by IDMP may also be required for compliance to other regulations.
- Accurate compliance needs tracking and distribution of attribute values. Attribute values submitted for IDMP, other regulations, and supporting internal business should be the same.
- Not only is MDM designed to collect and cleanse data, it is equally comfortable for data dispersion and co-ordination of values across systems.
Once business users assess the data management requirements, and consider the breadth of the IDMP scope, it is no surprise that some of them could be asking for a MDM solution. Even if they do not use the acronym ‘MDM’ they could actually be asking for MDM by capabilities rather than name.
Given the good technical fit of a MDM approach to IDMP compliance, I would like to put forward three arguments as to why the approach makes sense. There may be others, but these are the ones I feel are most compelling:
1. Better chance to meet tight submission time
There is slightly over 18 months left before the EMA requires IDMP compliance. Waiting for final guidance will not provide enough time for compliance. Using MDM you have a tool to begin with the most time consuming tasks: data discovery, collection and consolidation. Required XEVMPD data, and the draft guidance can serve as a guide as to where to focus your efforts.
2. Reduce Risk of non-compliance
With fines in Europe of ‘fines up to 5% of revenue’ at stake, risking non-compliance could be expensive. Not only will MDM increase your chance of compliance on July 1, 2016, but will give you a tool to manage your data to ensure ongoing compliance in terms of meeting deadlines for delivering new data, and data changes.
3. Your company will have a ready source of clean, multi-purpose product data
Unlike some Regulatory Information Management tools, MDM is not a single-purpose tool. It is specifically designed to provide consolidated, high-quality master data to multiple systems and business processes. This data source could be used to deliver high-quality data to multiple other initiatives, in particular compliance to other regulations, and projects addressing topics such as Traceability, Health Economics & Outcomes, Continuous Process Verification, Inventory Reduction.
So back to the original question – will the introduction of IDMP regulation in Europe result in the business asking IT to implement MDM? Perhaps they will, but not by name. It is still possible that they won’t. However, for those of you who have been struggling to get buy-in to MDM within your organisation, and you need to comply to IDMP, then you may be able to find some more allies (potentially with an approved budget) to support you in your MDM efforts.