| Dr. Lisa Held, Thomas Weßling
The way of process digitalisation in pharmacovigilance
Integrated into the digital strategy of the HWI group, the process of ICSR processing in the Vigilance and Quality Services department is being implemented completely digitalized using the Pega platform. ICSR stands for Individual Case Safety Report. This process of collecting and evaluating incoming suspected cases of adverse drug reactions represents one of the most important pillars of ongoing monitoring of the risk-benefit ratio of a drug.
What advantages does the digital process flow offer us?
Processing ICSRs is by far the most complex process in pharmacovigilance. Incoming reports have to be documented in a specific way, evaluated and ultimately reported to the competent authority. The process is made even more complex by the fact that at least two employees with different authorizations are involved in each case and that inaccurate or incomplete information is provided, especially in the case of reports made by patients.
The HWI group recognized the great potential of digitizing this process in terms of increasing effectiveness and maintaining the group's high-quality standards. A multidisciplinary team of specialists from the Digital Unit and Pharmacovigilance departments implemented the process in the low-code platform Pega. In the new solution within the Pega platform, employees are guided through the process, handovers to colleagues are done via automated email notification, open tasks are tracked, and deadlines are handled correctly. The system automates the organization of tasks and handles the auditing required by GxP. This allows the PV experts to focus completely on the activities that are technically challenging: the correct classification and evaluation of the reports.
Why does low-code / no-code help me digitize my processes?
Low-code / no-code platforms - such as the Pega platform - are very descriptive due to the visual nature of programming and are therefore relatively easy to use. Many elements that are common to processes, regardless of their specifics, such as forms, rules, post-switching of deadlines or reporting are already available, analogous to a modular system, and can be put together according to your own wishes. These prefabricated software modules make it possible to develop business apps with low-code platforms much faster than with conventional software development.
In addition, the team of pharmacovigilance employees and software developers from the HWI group was able to demonstrate how well a common understanding of requirements and feasibility succeeds within such low-code / no-code platforms. The graphical programming makes it easier to enter a discussion with each other at any time during development, in which the intermediate status of the development can be shown directly.
It is precisely this recurring coordination between software developers and the specialist department that is a central element within such a process digitization project and, if it fails, can also represent one of the greatest obstacles to digitization projects. Feedback in real time enables developers to try out changes immediately and make adjustments to suit the department exactly. This way of developing is thus very close to the idea of Design Thinking, in which the end user is placed in the focus of the application. The low-code / no-code environment Pega chosen by HWI even goes one step further here and establishes users directly as personas -- a prototypical characterization of a specific user group in Design Thinking -- around which the application is planned and built. The combination of user-centric development and iterative, agile working methods thus creates ideal conditions for successful process digitization that involves business departments and ensures high acceptance of the developed solution.
In addition to smooth internal processes as the basis for high-quality services, the focus of the HWI group is on the satisfaction of our customers. For us as a service provider, tailor-made process implementation for our clients has the highest priority. If necessary, adjustments can be made "behind the scenes" in order to implement specific change requests and complex process steps in a customized manner. Thanks to the advantage of standardization by means of low-code / no-code, we thus manage to digitize standard aspects in an uncomplicated manner and take time for the exciting aspects that provide our clients with real added value.
Why is low-code / no-code better for validating GxP-relevant processes?
The regulated environment poses special challenges for the development of software and defines, among other things, so-called non-functional requirements - in other words, how software must function. One example of this is data integrity. For each stored data record (so-called electronic record), the correctness, completeness and consistency must be ensured and proven at any time.
These guard rails can also be included and integrated as requirements in classic software development, but it should be noted here that this must be done and tested separately and repeatedly for each application. In low-code / no-code solutions, non-functional requirements are already provided at the platform level and are thus usable in all applications that build on them. Common requirements specific to the pharmaceutical and life sciences sectors have already been taken into account by providers of low-code / no-code platforms, implemented and, for the most part, certified by external parties, which makes it much easier to validate self-implemented processes.
In addition to the implementation of validation-specific requirements, the topic of software quality through standardization is given a very high priority in low-code / no-code. This is done by providing an integrated development and operating environment: While typically developers develop software in "their world", i.e. a completely detached working environment, which is then transferred to the target devices of the end users at the time of a release in a usually complex process, in low-code / no-code environments both parties work in the same environment. A constant environment is therefore used from the actual development, through testing, to the operation of the application. On the one hand, this reduces the effort required for releases (the provision of new versions of an application) and, on the other hand, enables an integrated test environment that is free from the influences of the final end device.
Testing is already a firmly integrated component in low-code / no-code environments, which can be used in the same way as the rest of the modular principle and can be individually extended as required. This makes it possible to quickly integrate standardized test and inspection routines that arise during software development in a validated context.
Result: more efficiency and safety.
Our low-code / no-code application for processing ICSRs is one of several projects with the help of which we are working on making pharmacovigilance processes more efficient and thus ultimately making drugs safer to continue to create confidence in our customers' products.
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