methodologies effecting the IDMP implementation: pick the right solution
June 14, 2016

IDMP has continued to be a hot topic in the pharma regulatory industry lately. It was expected that, in less than a month, EMA (European Medicines Agency)  would want companies to start utilizing the defined terminologies to be submitted from July 1st2016. However, this has been further delayed according to the other industry sources. The methodologies followed by companies decide the success or failure of the implementation. There are quite a few methods that experts prefer to deploy IDMP however, the solution supporting these methods needs to be stronger to streamline the process effectively. The competent the solution, the easier the execution.

Intelligent Pick for your IDMP Solution

Regardless of the type of methodology companies go for, a highly cost-effective yet robust data management software solution and accelerator should be combined with the strategy. A practical IDMP solution serves as the backbone of the implementation process. Listed below are few essential features that companies want to consider while selecting an IDMP solution:

  1. Screen, understand, and analyze the data and integrate with the source data as per the IDMP format provided by the authorities
  2. It should allow integration of data fields with designated term indicated in the controlled vocabularies (CV). The solution should offer to update the CV (Controlled Vocabularies) versions at all times and reflect those changes throughout the source data files.
  3. The software solution should ensure comprehensive change management integrated with a robust record management system and a unique reports generation capability.
  4. It should bid a simplified content abstraction process from dispersed documents and PDFs.
  5. Granular authoring is another aspect that increases the efficiency of the component level of data entry without delaying the process due to other incomplete components.
  6. Tracking the updates and flow of data add up to another important feature for a successful IDMP solution. It should allow the companies to automatically track, capture, and update any upcoming changes coming into.

Approaches to Accompany the Solution

Master Data Management (MDM)

There are several methods that companies have been following to get ready for IDMP and one of the specially designed methodologies is Master Data Management (MDM) approach. The MDM combined with Data Quality offers significant outcomes in terms of accuracy and efficiency of the data. MDM offers a wide scope for implementation since it allows using IDMP information on multiple platforms and adds value beyond the IDMP compliance, in other areas of the business.

Data Warehouse

Companies with a huge product line may adopt this approach. However, it works fine if combined with Data Quality since there is no information governance system such as MDM around it. Data Quality uses data quality rules, employ preemptive data quality management in this method that helps to keep the information consolidated, and improves efficiency.

In Conclusion

IDMP can be a successful venture for companies if they follow intelligent strategy combined with an intelligent solution. There is no doubt to the fact that IDMP implementation is challenging and demanding.  Regulatory teams need to be preemptive in terms of planning the entire IDMP implementation lifecycle by supporting the process with their strategic and rapid approach. This conjunction brings many variations in terms of strategic planning and functional teams. As the task is critical, a smart IDMP assessment and software solution is the key to success here.