By Maurada Georgina Darida, Junior Consultant and Denis Bele, Managing Consultant, PAS-X Excellence
Our Client and their Challenges
In a highly regulated industry where accuracy, traceability and reliability are not negotiable, this company is a pioneer in the biotechnology industry especially through the genetic material modulation technologies utilized for the prevention and treatment of diseases. Its research and development efforts are focused on several therapeutic areas where immune response is involved and cover both standardized and personalized medication.
The PAS-X MES system implemented by our client is specifically designed to meet pharmaceutical regulatory compliance requirements. However, regulatory compliance by design does not involve an inherently validated system, nor does it guarantee a streamlined validation process. In practice, various challenges may arise throughout the validation lifecycle. One such challenge encountered by our client involved the need to optimize the existing CSV approach.
The validation approach to date has been largely fragmented and manual, lacking centralized traceability and maintainability. Documentation was maintained using a spreadsheet-based software tool, relying heavily on manual data entry and synchronization after each update. This method presented operational inefficiencies due to the absence of robust version control, audit trail management, and real-time tracking.
Solution Design and Implementation
To address the inefficiencies and maintainability challenges in the legacy validation process, our team of experts embarked together with client on a structured transformation initiative centered around the capabilities of Azure DevOps. One of the goals was to design a digitally integrated validation framework that supports traceability, real-time collaboration, improved maintainability, audit trail support and usability between different parties.
Main goal of shift to a digitally supported way of work was also to utilize the so-called Template or Core approach that our client follows in their computerized system validation and to minimize validation efforts needed during rollouts of Template to the sites.
The change began with a thorough analysis of the current validation process including regulatory and internal obligations. Experts from FrontWell Solutions and QA leads from the client collaborated to map existing data structures and content to capabilities and functionalities offered within Azure DevOps. Azure DevOps functionality was used to accommodate validation needs through creation of Work Item Types for different elements like User requirements (URS), risks based on requirements, risks assessment, mitigation actions assessment and definition, including FAT/SAT, IQ, OQ and PQ phases, with deviation tracking and assessment. Work Item Hierarchies were established to maintain parent-child traceability, for example between URS, risks and defined Test Cases and Test Results. All stated configurations supported further plans to also visualize the data in a form that supports existing review procedures in place.
An automated Risk Assessment and Design Qualification Report generation was developed by FrontWell Solutions experts using JavaScript development language and at the end adjusted to Python scripting to fulfill also internal IT requirements from the client. Developed scripts utilized Azure DevOps APIs to fetch the data and the relations between them as they were defined. This provided visibility into the linkage between requirements, risks, test scripts, and outcomes, which is a critical asset for internal QA and regulatory audits.
A series of targeted training sessions were conducted for Validation leads, system owners and QA personnel to familiarize them with new workflows and tool usage. Additionally, developers and testers received training to ensure accurate documentation practices within the system.
Summary and Achievements
The implementation of Azure DevOps as a centralized validation management platform marked a significant step forward in optimization of client’s validation process. By aligning digital workflows with pharmaceutical regulatory requirements, the solution not only streamlined validation efforts but also laid the groundwork for future scalability and automation in other GxP processes with the highest level of data accuracy.
Through the implementation of the solution provided by the experts from FrontWell Solutions and internal personnel, our client has successfully transitioned from fragmented, manual validation methods to a digitally governed, end to end traceable, and audit-ready process.
With improved efficiency and compliance, stronger and more seamless cross-functional collaboration was established, enhancing transparency and providing real-time visibility into progress and potential blockers.
Optimized validation approach was already used in one of the site rollouts and shown in practice already benefits that were the main driver of the challenge that was presented.
In the present case, the solution was selected by the client and implemented with the technical expertise and support of FWS specialists. FrontWell Solutions also maintains a dedicated department equipped to assess and support such challenges comprehensively, analyze available market alternatives, and conduct detailed evaluations based on cost, operational efficiency, and alignment with the client’s specific requirements. This enables the delivery of tailored solutions that optimize efficiency, cost-effectiveness, and adaptability.
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Our Company
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 12 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.
Moreover, we have partnered with prominent digital solutions platforms in the market, showcasing our proficiency in leveraging cutting-edge technology.
We can support you with our well-trained LabVantage experts (Business Analysts and Solution Engineers) as well as our Validation Excellence Team with long-term experience in the field.
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.
Case Study: Utilization of Azure DevOps to optimize Computerized Systems Validation process