By Ulf Koester-Oracle on Dec 01, 2015
Article written by Henry Dünnebeil, Oracle Sales Specialist
The new upcoming EMA requirement to use the ISO standards for the IDentification of Medicinal Products turned out to be quite a wake-up call for drug makers, forcing them to (re-)think how to more effectively manage their product data cross-functionally to ensure and maintain compliance. Now hundreds of attributes from dozens of dispersed data sources including documents and databases have to be extracted, cleansed, validated, and then managed and change-controlled in a central repository to share with regulatory bodies – potentially a huge burden and scientific project – and very welcome work for armies of consultants and tool providers.
Since a couple of months, Oracle has been running a survey called “What is your IDMP Strategy?” (https://www.surveymonkey.com/s/oracleidmp), trying to find out how pharma companies are approaching the IDMP challenge, and if they see it as just another regulatory burden to meet or if they see the real opportunity behind it – to fundamentally change the way of managing product information – from a document-centric process to structured collaborative information management across internal and external domains and stakeholders.
And the outcome so far is that most respondents indeed do see IDMP as a cross-functional exercise – although mainly driven by Regulatory Affairs – and an opportunity to improve collaboration, but at the same time they see massive risks and an increased cost of compliance.
Many companies begin strategizing their IDMP implementation by thinking about it as an extension to xEVMPD. However, manual xEVMPD processes do not scale to IDMP data set sizes and much of the IDMP data isn't even in Regulatory Affairs. So many organizations think about building IDMP specific solutions and most of them quickly mature to adopting a master data management (MDM) approach. This is certainly an improvement because data is integrated more or less automatically with MDM.
So yes - the MDM approach can deliver IDMP compliance.
The short questions are: How - when - at which cost and efforts?
Looking closer, more detailed questions arise – such as:
- Can we use/extend our existing MDM to manage IDMP data and what are the efforts and risks ?
- If not, shall we use IDMP to build a new MDM? Is this feasible at all?
- Maybe we should establish an IDMP-specific MDM (e.g. as a Regulatory Product Information System) - but do we really want another data island?
- How do we feed and synchronize the MDM system with clean IDMP data?
- Where do we maintain IDMP relevant data – in MDM or the source systems?
- Which system(s) govern IDMP data?
- How do we ensure auditable change control of IDMP data?
- How many integrations/synchronizations do we need to build and maintain?
- Where do we handle the secured exchange on IDMP with regulators?
- And what if another new regulation appears – will our MDM still be able to cope with it?
- And finally: Can MDM unlock the full value opportunity that hides behind IDMP?
Do you recognize some of these questions and do you have answers? Here is our view:
IDMP is really about bringing together Clinical, Safety and Product Quality/CMC in a compliant data record. The only way to get there - without dramatically increasing the cost of compliance and doing business - is to change the ways of working from the traditional silo behavior to cross-functional process integration. Only the focus on process improvement will demonstrate unmatchable value compared to the classic back-office data based integration. So you need a solution that enables and supports this process – and that provides IDMP compliance as a “by-product”!
Oracle with its Enterprise IDMP Foundations Suite clearly addresses the same benefit as MDM (automated data integration) but then goes one step further, addressing the shortcomings of MDM and culminating in a cross-functional integration of people, data, and processes. Based on proven, mature applications the Oracle IDMP approach is aimed to provide a ready to use IDMP repository with an integrated collaboration and change management platform out-of-the-box and then giving pharma companies the opportunity to re-think and improve their processes and integrations step by step.
Here are some of Oracle's differentiators vs. MDM projects and IDMP-specific applications:
So why only address half the problem with an MDM project when there's an opportunity to be IDMP ready in 3 months and unlock full “Product Lifecycle Management” capabilities in the future?
We are looking forward to discussing the topic with you in detail and, together with our Life Sciences Team, help you create the right strategy for IDMP and beyond.