Over the last 4 years, we have seen a surge (across industries) in the number of apps deployed by organizations (175 for large organizations and 73 for smaller organizations on average) (Okta Inc., 2021). An explanation for the large number of applications is the fact, that businesses are moving into deploying applications, that are special purpose and best of breed as opposed to monolithic systems covering multiple application areas.
Now, if you consider that software vendors are pushing clients to take on updates at a higher pace, to maintain all clients on latest software – reducing both security and churn liabilities (you are more likely to switch vendor, if you are running on outdated software) we start seeing a massive wave. That wave is radically impacting and changing the IT-departments of all industries – but pharmaceuticals more so, than any other industry.
Unchallenged by anyone, the pharmaceutical Industry is under heavy regulation. And regulations tend to grow rapidly compared to the size of the enabling law. F.ex., the United States Food and Drug Administration (US FDA) has the rule-making responsibility for the “Food, Drug, and Cosmetic Act” of 1938 in the United States (US). The “Food, Drug, and Cosmetic Act” consisted of 19 pages. Today, Code of Federal Regulations Title 21, which enforces the same law, requires nine volumes containing over 4,000 pages (Lezotre, 2014).
When it comes to IT in the pharmaceutical Industry, IT departments are doing what IT departments in any industry know, that they should be doing. Rigorously test solutions and updates by a completely structured protocol before deployment and secure that users are adequately trained on all deployment and updates. Unlike any other IT department, the pharmaceutical Industry are doing so because they have to
Joachim Schiermacher, CEO, ClickLearn
Pharmaceutical companies will need to test any release (whether it comes in the form of an “update” or a larger “upgrade”). They can do so in the compromise of a risk-based approach to validation, focusing efforts on the parts of the system that most pose a risk to human health and safety. Although there is undeniably some room for “wagging the tail”, it certainly does not exempt pharmaceutical businesses from testing any and all release on key processes.
My conversations with a pharmaceutical company left me convinced that what the entire vendor landscape is doing for the good of everyone, certainly does not benefit the pharmaceutical industry. The CIO of one such company stated that he was unable to take on updates in their ERP system with any acceptable frequency. He was simply unable to complete a test cycle of more than 300 internal processes before the next upgrade was available. If nothing else, this will leave you in a state of pure despair.
Now, testing solutions are available, but the input and configuration process is cumbersome and will deliver limited time savings.
When you implement your major ERP system or any other software, you will typically describe your processes. This is mandatory for pharmaceuticals under CGMP (Current Good Manufacturing Practice). As such that description is the foundation for both training, performance support and testing any new release. Why is the pharmaceutical industry obligated to maintain and create two isolated descriptions of virtually the same process in two system?
Under CGMP all users must be trained on the proper use of the system. But the projects responsible for implementing new technology are often focused on meeting deadlines and bringing the system to work. More so than ensuring the training and adequate performance of the end users in the new system.
According to Forbes 84 % of digital transformation projects fail and a large number on the background of lack of adoption. Creating a training universe, that is not updated with each new release and therefore will look as current as a Greek statue after a few releases, is not viable way to support users in taking on the challenge – not even mentioning, the experience that an employee onboarded after the initial implementation is getting.
The pharmaceuticals, more than any other industry, need a training system that works and updates with new release with little to no effort.
ClickLearn – a combination built for adopting and maintaining software
With ClickLearn you will describe your processes once for any IT-system, You will do so by recording the process in a test system, we will automatically convert your recordings into a 24/7 available e-learning portal with narrated videos, test-me simulations for certifications and of course hand-on-labs, that allow the users to train on their own time. For performance support and supporting the users on infrequently performed processes (think travel expenses and you will know, that it is difficult to train on) we generate virtual assistants, that guide the users inside your applications and make them available when the user needs them. Our automatic replay, will keep your training platform current as you deploy new updates or upgrades of your business system
For your Computer System Validation (CSV), we will use the same process recordings, that you deployed for your training and deliver an automated environment to execute your tests in hours, not months and deliver a compliant test result. So you will in fact be able to execute tests on new updates.