High Compliance Software Made Simple: Digital Adoption in Pharma
Welcome to the first edition of the ‘Masters of Digital Adoption’ newsletter, brought to you by Userlane.?
This series aims to provide you with practical advice on how to realize the full value of your software investments from experts across a mix of industries.?
Digitalization processes and their associated requirements for software efficiency pose significant challenges in the life sciences industry. These range from adhering to Good Practices (GxP) regulations to managing complex processes. We engaged with MAIN5 to explore the issue of digital adoption within the industry and strategies to address its complexity.
Continuous pursuit of process excellence
Effectiveness, particularly in research and development, is increasingly challenged in the pharmaceutical industry.
Nevertheless, successful research alone does not guarantee holistic success. The pursuit of process excellence and the optimization and change of the current situation inject new momentum and untapped energies.
Focus on the systems and processes.
The growing regulatory requirements across all disciplines ensure that intellectual treasures are represented in databases and documents. A focus on the systems and processes of regulated data and document control in clinical development, approval and more contributes sustainably to compliance, efficiency and productivity.
New technologies on the path to success
The countless possibilities of digitalization range from more efficient laboratory work to developing and approving effective therapies. Thinking work automated by artificial intelligence is already accelerating and improving research, development, and approval operations. MAIN5 works in an advisory capacity with leading technology providers who have proven successful
Vast software landscape complexity.
The pharmaceutical industry uses a variety of technologies through the life cycle of product development governed by quality and GxP compliance rules. Different by geography and many other factors, there is no one-size-fits-all approach.?
Data integrity and process accuracy are at the core of all technology used in this industry, as both are vital for the authorization of new drugs in any market. Here is an overview of the software used in the life cycle of product development:
High training requirements
For the most part, users receive guidance on all systems required to complete their work, but the level of detail can vary considerably. According to regulations, training should be documented and evaluated for effectiveness, and employees must be trained in an appropriate manner. However, there are no details on how to assess this. Businesses can interpret this guidance in different ways, making it particularly challenging to evaluate and improve.
What is, however, universal is the notion that compliance is critical, which has led to the creation of very detailed training guides. As a result, employees are required to read a 100-page document and develop a deep understanding of the system before any process is started. Clearly, this approach is not suitable for training at scale or pace.?
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Digital Adoption Awareness
?Digital adoption is part of the unknown. There has not been a simple solution for this pain point. People need more awareness that there is already a solution that can make a difference to patient safety, product quality, and data integrity.
Alexander T. , Managing Partner at MAIN5
There are several options to evaluate when looking to solve for complexity. However, digital adoption platforms present an immediate potential gain through targeted and measured in-process user guidance. ?Not only can the use of a Digital adoption platform help accelerate their daily tasks, but it also reduces time to task completion on the required assignments. The Digital Adoption Platform (DAP), can help by:
Wrapping up - best practices
Guided onboarding and focused learning content at the time of need are considerable advantages compared to traditional learning approaches. In addition, integrated analytics provides insights to optimize learning success. Moreover, the software adoption analytics framework can be used to evaluate user engagement, performance, and adoption rates.
How can the life science industry realize the value of software investment??
MAIN5 's advice for mastering digital adoption is to foster a culture of continuous learning, innovation, and adaptability within your organization. Embracing this mindset will help employees become more open to change, encourage collaboration, and drive the successful implementation and adoption of new digital tools and technologies.
Authors: Sabine G?lden , Alexander T. , Bengi Tetik