GxP Reporting Automation: from 5 Weeks to 5 Minutes

About the Project

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Our client, a leading research-focused biopharmaceutical company developing and delivering life-saving medicines, was seeking help with solving a problem — tedious reporting procedures and reliance on manual processes. 

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Utilizing our expertise in R Shiny applications, we successfully automated 85% of GxP document generation, and reduced the time needed to generate CPV, APR and App Stability Testing reports from an average of 5 weeks to an average of 5 minutes! This initiative led to time and cost savings, as well as more efficient, accurate, and compliant reporting in a highly regulated pharmaceutical environment.

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Background

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Reporting procedures for pharmaceutical companies are often hindered by traditional methods, a reliance on manual processes, and the strict requirements of GxP compliance. From the earliest stages of product research and development, GxP helps ensure continuous improvement and proper risk management in the drug manufacturing process.

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Meeting the Client’s Needs

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Our Client, a global leader in the pharmaceutical industry, was looking for the best solution to automate reporting and save time by ridding their processes of manually handled methodologies. Their goal was to increase efficiency as much as possible and remove the risk of human error while adhering to GxP standards.

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From day 1, our primary objective was delivering immediate, lasting value to our client. This commitment guided our approach to application development and process improvement. Working with the Client's Teams, gaining a thorough understanding of their specific challenges and constraints, we began improving and expanding their existing R Shiny applications. 

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Solution to the Challenge

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Appsilon’s dedicated team of four experts helped overhaul the Client’s reporting systems. We introduced Agile methodologies, with a focus on best practices for software development. 

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We used R, Shiny, and JavaScript, to enhance and automate the report generation process. Shiny is highly effective when integrating complex database queries, data processing, analysis, and validation using R's robust capabilities. With the addition of JavaScript and CSS it allowed us to craft custom, beautiful and feature-rich user interfaces.

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This allowed for the development of reusable components, enhancing the value delivered across all client projects, and for easier user adoption.

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Key Initiatives Included

• Development of robust R Shiny applications compliant with GxP standards: APR (Annual Product Report), CPV (Continued Process Verification).
• Leveraging agile practices and tools like GIT and Posit's Package Manager for streamlined development.
• Crafting a user-friendly UI and enhancing UX for all applications.

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This led to improved time efficiency in manufacturing, allowing teams to focus on high-value tasks, improved data presentation and accessibility through an interactive and visually appealing UI as well as enabling high quality analysis, leveraging GMP (Good Manufacturing Practices) data for comprehensive reports.

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Major Milestones

• Development of a tailored, Client-branded reusable UI components package.
• Launch of an interactive applications for CPV, APR and Stability Testing App for customized reporting, data analysis and visualization.
• Integration of Jenkins and later Github Actions for continuous integration in code repository and continuous deployment to Posit Connect.
• Appsilon helped consolidate internal tools and packages for report generating, reports templates, data analytics and visualization within a single platform. 

Results

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What our Clients Say:

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“They had a good reputation based on our research. Their team seemed to build world-class Shiny applications that we’d be looking for. We went through the interview process with them and a few other companies. We liked what we heard with Appsilon, and decided to move forward.

The project was successful, and our team is highly impressed. Our customers are extremely delighted by the quality of the application as well. The quality of their work is extremely good. We were also impressed with the communication about what was being worked on as well as their integrity and honesty.”