Our Client and their Challenges
In the dynamic world of biopharmaceuticals, this company stands out for its dedication to innovation and patient care. With a focus on treatments across neurology, psychiatry, oncology, and hematology, this company has established itself as a pioneer in the industry.
With a strong global presence and operating according to cGMP (Current Good Manufacturing Practice) and Food and Drug Administration (FDA) regulations, they have more than 5,000 individuals dedicated to advance in healthcare solutions. However, like any organization, they encounter challenges. One such challenge lies in their outdated manual logging system.
Spending an average of 95 days annually on managing and archiving paper logbooks, along with issuing 570 logbooks in 2023, the company found itself struggling with inefficiencies in its documentation processes, where they additionally found an average of 4.5 GMP errors per month during the review process. Moreover, the difficulty in tracking and tracing logged actions added another layer of complexity.
With the paper-based system, ensuring accuracy and compliance was a time-consuming task and reviewing logged entries and the audit process presented additional challenges. Making changes to the processes and logbooks complicated the case, requiring coordination and communication across teams.
Recognizing the need for a transformative approach, the company embarked on a journey of digitalization by hiring FrontWell Solutions.
In this case study we dive into the implementation method and how we designed digital solutions based on regulations and their requirements.
Solution Design and Implementation by FrontWell Solutions
The company made the strategic choice to utilize Tulip Interfaces to digitalize their record keeping processes. Tulip is a no-code platform for solution design, known for its user-friendly interface and rapid implementation capabilities. Moreover, enabling straightforward and swift implementation, significantly accelerating the entire development process from inception to execution.
As certified Tulip partner, our experts at FrontWell Solutions took the lead for the solution design process in close collaboration with the client.
The journey began with an onsite visit and workshop aimed at comprehensively understanding the company's business objectives. Subsequently, a detailed process analysis of frontline operations and activities was conducted to identify areas for improvement.
The solution was then further optimized through an agile development process, ensuring rapid progress and tangible outcomes, where after only two weeks, the first functional apps were ready for testing. Following the development phase, the apps were deployed on the shop floor, seamlessly integrating into daily operations to be 1:1 compared with the originally utilized paper solutions.
Feedback from Operators
Throughout this journey, operator feedback played a pivotal role, to ensure optimal usability and efficiency of the solution.
Based on their feedback, Digital logbooks achieved a 100% error-free record, ensuring data accuracy and regulatory compliance, while allowing 95% reduction in processing time, accelerating workflow efficiency. Furthermore, 80% of operators find logging information easier with the digital tool, improving user experience and productivity.
Summary and Achievements
By utilizing digital solutions for record keeping, the company achieved many benefits across its operational landscape:
- Implementation of e-logbooks has resulted in substantial time savings across various stages, including generation, processing, and archiving of logbooks at the site.
- A significant reduction in errors and deviations has been achieved through the adoption of electronic logbooks, leading to a much higher level of compliance, and enhancing overall quality control measures while decreasing costs.
- The solution has demonstrated scalability by consolidating multiple logbooks within a single streamlined process, paving the way for efficient management and optimization of resources. The convergence of data has also given way to better KPIs and metrics that go beyond a single use case.
Our implementation approach enabled delivery of quick wins and generating fast return on investment.
Additionally, the establishment of a centralized digital platform for manufacturing operations not only addresses immediate needs, but also sets the stage for future digitalization initiatives, such as Electronic Batch Records (EBR), unlocking a new era of innovation and efficiency in their operations.
Our Expertise Go Far Beyond Logbooks
FrontWell Solutions is an expert in the digital transformation of the pharmaceutical manufacturing process. Our team of experts is engaged in providing digital solutions to 10 of the 20-leading pharmaceutical, biotechnology, chemical, and medical device companies and suppliers spanning Europe, the United States, and Asia.
Our expertise lies in delivering specialized consulting services, primarily centered around Manufacturing Execution Systems (MES), Laboratory Information Management Systems (LIMS), seamlessly integrating these Level 3 systems with Enterprise Resource Planning (ERP) platforms and driving Manufacturing Intelligence initiatives such as Overall Equipment Effectiveness (OEE) reporting.
Meet the team behind this success:
Get in Touch with Our Experts
Thinking about taking your next steps towards the digitalization journey? We are ready to support you! Contact us under ReachUs@frontwell-solutions.com or via +49 (6101) 595 89 85.
Author: Dr. Paria Pouyan
Streamlining Biopharmaceutical Operations: A Case Study in Logbook Digitalization with Tulip Platform