Time to relax or time to do more work?
Q4 2018 may seem far, far away, but there is still lot to prepare for between now and then.
Many companies have already started their IDMP initiatives by conducting IDMP readiness assessments or gap analysis’, thus having created an awareness and built a momentum for delivering to IDMP across the organization.
With the most recent, but maybe not last, delay of the EMA IDMP guidelines, many Life Sciences companies are slowing the pace of their IDMP implementation projects. While this is an obvious natural tendency, it may be creating organizational risk as IDMP projects drop further down the list of priorities.
If you’re driving IDMP efforts, you’re probably asking yourself the same questions as most others in the industry:
- Where can we currently move ahead with activities without taking too much risk?
- Which activities should we defer and how do we avoid losing the awareness, knowledge and momentum we have already built across the organization through our assessment phase by when doing so?
One way of addressing these questions is to start looking at IDMP as a broader strategic initiative, rather than simply another tactical regulatory challenge and compliance project. How can IDMP be anything but a compliance project? Framing the project in that way introduces several business advantages.
- Standardizing and centralizing product information, which will likely also come in handy during recalls and counterfeiting investigations
- Improving product safety and regulatory efficiency by moving from regulatory document management to regulatory data management.
IDMP and related projects should address the challenges identified in your readiness assessment, which typically include:
Unstructured Data: The majority of IDMP data is located in unstructured forms, including an estimated 70% or more contained in documents. The volume and variety of unstructured data will only grow once a full data inventory is completed for all your products and countries in your organization.
Common Identifiers: Most data sources do not share common identifiers to enable a robust way of relating the right data.
Siloed Information: In most cases, product data in quality, manufacturing, and regulatory groups resides in siloed systems with limited sharing and integration. This disparity makes it difficult, if not impossible, to gain any real or even trustworthy insights.
Visibility and Access: Disparate systems, unstructured data, lack of data governance all lead up to a decrease in visibility and access to affiliate and manufacturing site level data and documentation.
Opportunity to Transform
The EMA’s enforcement delay gives us more time to thoughtfully and efficiently re-think how we manage product data, as opposed to creating a quick fix to meet a compliance deadline. In the long run, the “strategic initiative” approach to IDMP preparation will save you time, money, and headaches—and this delay will give you the extra time you need to plan and execute. I mean, you’ll have to be compliant with IDMP eventually any way, may as well benefit from the tangential business benefits of implementing a full data strategy up front.
Ready to get started?
- Develop a single product data repository based on IDMP that would allow cross-functional teams to maintain and share product information seamlessly across the organization while retaining the ability to tie in to additional functional data as required locally.
- Consolidate and integrate systems along with your data to reduce the likelihood of data quality issues and redundancy. For example, consolidate multiple document repositories.
- Expand the use of existing systems to eliminate document data sources where appropriate. For example, manage CTAs in your RIM system, if not already done.
- Implement new functional systems to eliminate document data sources where appropriate. For example, implement a RIM system, if not already in place.
- Experiment with new technologies allowing you to semi-automate the extraction of data from the documents making up the majority of your IDMP source data. If successful, you have a data management capability which can be leveraged for many other purposes than IDMP.
- Prepare your organization for the future use of IDMP data to deliver on other regulatory requirements such as the Falsified Medicines Directive (FMD) or e-prescription.
Are you prepared for upcoming IDMP data standard changes? Join us Wednesday, October 26 at 11:00 a.m. EST 4:00 p.m. CET for our IDMP Substances Webinar – a unique opportunity to collaborate with industry experts and peers.