Master Data Management (for regulatory product data submissions)

Master Data Management (MDM) heavily relies on the principles of data governance with a goal of creating a trusted and authoritative view of a company’s data. The main purpose of this data management discipline is to create a single trusted golden source for data ensuring the accuracy, traceability and accountability of the enterprise’s official shared master data assets.

Three reasons why you should invest in MDM - Benefits

• Multiple Functional silos and complex organizational structures: For the purposes of regulatory product submissions, complex organizations have to bring data together into a single trusted source. MDM technology can help with executing formatting rules, standardization, deciding which data prevails, etc. and additionally trigger data management processes such as enrichment or enhancement, where data requires additional preparation or validation prior to the regulatory submission purpose.

• Traceability / inspection readiness: When data is submitted to the regulator, it’s critical to understand its full traceability, in order to be inspection-ready as well as to be in control of end-to-end regulatory data submissions processes. MDM technology can help with this, by means of data lineage.

• Data Strategy / Data-driven enterprise: Organizations with clear, well-established data strategies in place, including data governance and data management practices, can greatly benefit from the addition of MDM (both practices and technology). It could bring these organizations to the next level of maturity in context of data management, by automating and streamlining these processes to a large extent. Alignment to common master data can then drive further enterprise benefits by presenting single trusted sources of truth while eliminating redundant data re-entry. 

Three reasons why an MDM investment would be better postponed

• No suitable Business Case: First of all, MDM is not a cheap investment, both from a technology as well as from a resources point of view. A clear business case is therefore mandatory, preferably one with “beyond regulatory compliance” benefits. In principle, articulating such a business case shouldn’t be too difficult, as operational efficiency improvements are usually within reach.

• MDM simply unnecessary: Some companies might conclude that MDM is simply not necessary when they find themselves using only single integrated life sciences platforms. These (typically small-to-mid size) companies don’t have a large legacy and achieving a single trusted source of truth does not require any additional investment. For instance, when all the regulatory data is maintained in one place without multiple sources, by a data steward who is responsible for each data point. If that single trusted source can be achieved through one system alone, there is no point in adding another system.

• Small Portfolio size: It is very common that a company with mid-size portfolio is able to establish a centralized data entry / data management capability that is effectively creating the “master data” in a single system such as the regulatory information management system (RIMS). In that case, to have another information system like an MDM tool might not be required.

Conclusion

From any perspective, MDM has several advantages to offer to the organizations regarding regulatory product data submissions. However, it could be a redundant investment for the companies if it is not really required, that would make the existing data management technique more complicated or potentially become an unwanted burden or even lead to waste of money. Although in any case it depends on individual business cases, as mentioned above.