Struggling With GxP Systems? There's A DAP For That
By Sabine Gölden, MAIN5
As digital transformation continues apace across life sciences GxP processes, the pressure to get the most out of new systems is rising exponentially. That starts with ensuring employees use them properly, which, ironically, is becoming harder rather than easier.
In pharma and medtech, as in so many other industries, employees are overwhelmed by the complexity and multitude of digital processes, systems, and associated changes. A typical international enterprise now has 500+ different software applications, with single departments often running more than 80. For individuals to engage with those systems confidently — and correctly — good training is necessary, as well as regular use to build in good practices. But this can’t always be counted on. Even today, IT training is often seen as a check-box exercise, and there are critical systems that some teams or team members will need to use only a handful of times per year, challenging them to remember what they were taught.
It is in this context that digital adoption platforms (DAPs) are rapidly gaining traction in a life sciences GxP context — guiding users in what is required at every step, long after systems have gone live.
DAPs are software overlays for cloud/web-based IT systems. They sit on top of these applications and guide users through tasks such as form-filling and data entry, at each stage reminding them of what exactly is needed, how to format it correctly, and what to do next.
Always online and available to the user, these capabilities have been shown to halve the time spent on regular training and e-learning materials creation and to halve the post go-live support burden.
The Meteoric Rise Of DAPs
Already worth an estimated $1.16 billion in 2024, the DAP market is predicted to reach $3.84 billion by 2032.1 The main driver is the growing need to improve user adoption rates for new software and applications — especially those with complex features — via easy in-app guidance and support.
DAPs are already commonplace in many large enterprises, but more typically on the commercial side of the organization, or in central functions such as human resources (e.g., to support comprehensive cloud-based systems like Workday). This means companies often already have licenses for the platforms; to broaden the reach of those platforms, they just need to generate targeted materials for other use cases and software applications.
In pharma clinical, regulatory, quality, and pharmacovigilance functions, there are other pressures beyond smoothing the user experience and ensuring robust adoption of new and updated software systems, including advanced regulatory information (RIM) systems, quality management systems (QMSs), and systems for signal monitoring and safety reporting.
Most obviously, there is GxP compliance, which demands proper training on new systems. Although training on new systems is a prerequisite in a GxP context, this doesn’t automatically guarantee compliant use. Such training is rarely vetted for its quality or efficacy. This poses a risk, especially as key regulatory, quality, and safety processes become more data driven.
The pivot from document-based operations and health authority exchanges to data-driven decision-making and the need to conform with comprehensive new and expanding standards such as ISO IDMP compound the need to use new or updated systems correctly and to input good data reliably and consistently. That might include bringing across the right data, in the correct format, from older systems now being retired.
Data integrity, data quality, and data governance are high on the life sciences agenda now. Relying on training alone, or on the inherent intuitive qualities of modern systems, gives a false sense of security now that so much hinges on the ability to call up, exchange, and reuse data as the basis for important insights and critical reports.
Linked to this, up-front system training alone won’t ensure that individuals uniformly adhere to agreed naming conventions or data structures when inputting critical information. Failure to do this will undermine the higher aims for that data and its reuse in a range of different contexts. The various DAP vendors claim upward of 20% improvements in data accuracy, on the other hand, when real-time prompts are given during application use.2
DAPs’ Role And Scope
So, how do DAPs work? The first thing to note is that they don’t touch or interact with a system’s data, so they do not introduce a new security or data protection risk. And because such a platform is an overlay, it remains agile and adaptable. Where traditional e-learning materials involve a lot of screenshots to illustrate what to do where, these can soon become outdated when systems, fields, or data requirements are revised over time. Given that cloud applications may be refreshed several times a year, this is a valid consideration. DAPs are much easier to amend on the fly.
DAP guides will ideally be tailored for respective roles, too, ensuring that users are served only with prompts that are relevant to them when they interact with a given system. Users can exit the guides, too, once they are sure of what’s needed or if they are working with the software routinely. Metrics (e.g., HEART analytics, monitoring Happiness, Engagement, Adoption, Retention, and Task Success) that are built into the platforms, meanwhile, provide useful feedback to team managers about points of particular difficulty in a system. This can help with the fine-tuning of software features, and/or of up-front training.
Improved Engagement With Every User
The key to DAPs’ efficacy and impact is inextricably linked to the strength of the guidance they contain. This needs to be planned optimally per user group and role and refreshed over time to give appropriate instructions. One of the features companies really like about DAPs is the facility to reliably make system-related announcements to all users as they log in, e.g., about changes to the system or to data input requirements (rather than hoping a blanket email will reach them).
As for more traditional training, its value remains, but DAPs allow more of this to be focused on the more strategic and high-level aspects of a new system and its purpose. This allows companies to allocate their budgets and materials expenditures more efficiently and deliver shorter courses.
Although DAPs themselves do not inherently make use of AI, the platforms are coming into their own as AI begins to permeate more everyday operational software. That’s because AI, in common with any new technology, needs to be used carefully and correctly to elicit reliable results. And DAPs are ideal as a mechanism to provide the necessary just-in-time, in-app guidance.
Above all, DAPs are designed to bring the intuitive experience to users that today’s advanced GxP systems may lack — in a way that is likely to become more predictive over time. Here, think of a DAP overlay as an advanced take on the Microsoft Word “paperclip” assistant of old: “It looks like you’re entering new drug substance and product information, do you need help?” or “Can I support you by choosing the right dropdown value for your CAPA (corrective and preventive action)?”
It is for all of these reasons that 2025 is set to be the year of the DAP in a pharma GxP context.
References
- Digital Adoption Platform (DAP) Software Market Size, Share, Growth, and Industry Analysis, By Type (On-premises and Cloud-based), By Application (SMEs and Large Enterprises), and Regional Insights and Forecast to 2032, Business Research Insights, Updated March 2025: https://www.businessresearchinsights.com/market-reports/digital-adoption-platform-dap-software-market-118149
- Value of a DAP, white paper, Whatfix: https://whatfix.com/resources/whitepapers/value-of-a-digital-adoption-platform/
About The Author:
Sabine Gölden is eLearning & training lead at MAIN5, a European consulting firm delivering digitally-enabled change in life sciences. Gölden can be reached via email at sabine.goelden@main5.de.