IDMP Deadlines and Non-Compliance Implications:
EMA is still firming up the implementation time lines as of July 2016. It is generally expected that IDMP implementation guides will be released in early 2017. Non-compliance with IDMP regulations can result in huge penalties sometimes upto 5 % of the company's revenue.
- IDMP is a cross functional enterprise-wide endeavor requiring deep and specialized expertise, often not readily available in many organizations.
- IDMP data resides in multiple systems and documents within an enterprise, varying in format and structure, requiring extensive data wrangling.
- No reliable COTS based solution exits for IDMP compliance. The custom solutions varies greatly in cost and complexity depending on various factors including number of medicinal products, markets and implementation partners.
Transformative Solution to IDMP Compliance:
While many approaches can be used to achieve IDMP compliance, I believe that Master Data Management & Governance (MDMG) based solution is the most robust that can be a catalyst to a larger enterprise-wide transformation. Implemented in a phased manner, this approach addresses the immediate need for IDMP compliance and on the long run, harmonize and standardize enterprise-wide master data.
Phase one of MDMG based approach, involves creating a layer of data abstraction on top of multiple enterprise systems that contain IDMP relevant data. This layer would transform and standardize data from multiple data sources into an IDMP compliant, submission ready data format that resides in the MDM repository. This repository then serves as an enterprise wide "Gold Source" for IDMP compliant data that can be syndicated and consumed by other systems such as manufacturing, labelling etc.
Phase two of MDMG approach would extend the functionality of MDM system and governance framework, to other enterprise master data entities within the organization. This phased approach reduces risk and complexity of an enterprise-wide MDMG initiative, while readily addressing the immediate need of IDMP compliance. This approach will provide better return on investment (ROI) and a lower Total Cost of Ownership (TCO).