Gauging IDMP maturity to reap the full benefits of a digital product information management future
Summary
The European Medicines Agency (EMA) has recently published the second version of its EU IDMP Implementation Guide, and it is a landmark regulation for software vendors and pharma companies alike. This has the potential to go way beyond a technology-based transformation and IDMP preparations should encompass changes to processes (not just data management processes, but also core regulatory business processes that are part of the value chain) to ensure they are working with the best possible data, supported by appropriate governance.- Author Company: Iperion
- Author Name: Adnan Jamil
- Author Email: kelly.tipper@pharmiweb.com
- Author Telephone: +441344851506
Gauging IDMP maturity to reap the full benefits of a digital product information management future
The European Medicines Agency (EMA) has recently published the second version of its EU IDMP Implementation Guide, and it is a landmark regulation for software vendors and pharma companies alike. This has the potential to go way beyond a technology-based transformation and IDMP preparations should encompass changes to processes (not just data management processes, but also core regulatory business processes that are part of the value chain) to ensure they are working with the best possible data, supported by appropriate governance.
But how ready are companies to move forward and what’s the best approach to take when becoming IDMP ready? The answer lies with an IDMP maturity assessment, which can be broken down into four categories:
Process & governance - if a great software system is applied to ill-fitting processes, the desired transformation will be greatly compromised. So it’s important to start by reviewing all processes currently affecting the way data is generated, captured, checked, combined and maintained, and how this feeds into existing document/dossier creation.
Drawing on industry-standard IDMP process reference models, this knowledge will help inform the necessary process changes – and estimate the effort needed to implement them.
Organisational - as companies realise the potential of working with data and a single, central master version of their product truth - managing product-related information will transcend the remit of Regulatory Affairs. If companies want to fully capitalise on the potential of a new data-focused way of thinking, planning and ensuring quality and safety, it follows that maintaining a consistent, high-quality master data set will be a task bigger than any one department.
An organisational assessment – an assessment of the company’s readiness for organizational change - will help ensure that the right stakeholder groups are given the attention they need throughout the digital transformation that is IDMP implementation.
Technology – this is important in its own right but needs to be considered in tandem with process/organisational findings to ensure that any system updates or replacements are able to support the new target operating model (in which data and documents are submitted in sync). Moreover, both individual system and overall architecture provisions must be looked at with an eye on future compliance needs and other data-driven process ambitions.
Taking in analysis of the current system architecture, as well as the core systems of interest, the goal should be to define a fit-for-purpose technology strategy.
Data - the data assessment should aim towards a detailed understanding of the location, ownership, quality and quantity of the company’s IDMP data set, such as it is currently. This will enable the planning of tailored data remediation activities.
Companies are likely to need some help here – to understand more fully the IDMP data model, the ins and outs of the latest EU Implementation Guide, as well as the typical business processes generating and/or handling IDMP data.
Informing your overall IDMP strategy
These assessments will help inform a pragmatic, futureproof IDMP vision and strategy and an optimally aligned IDMP roadmap and implementation plan. It’s important to bear in mind that any IDMP strategy dovetails with/does not conflict with any other pivotal company initiatives, such as the organisation’s broader enterprise data strategy.
The final push should be to set out a clear IDMP roadmap and implementation plan, one which doesn’t try and do everything in a first project release. Attempting too much too much could derail the whole project. Company-wide master data management (MDM) – extending across RIM, Pharmacovigilance/Safety and ERP – is the end goal, but it’s advisable to start with a leaner program that can be built on over time.
IDMP implementation is a highly significant step for the industry, that will transform how data is used across the business. But to make the most of IDMP, firms must first be IDMP-ready, and the assessments outlined above are an essential element in achieving that.
About the author
Adnan Jamil is a Senior Consultant at Iperion, now part of Deloitte.
