Rapid Onboarding of FACT-Compliant Electronic Record Systems

• Published in: Transplantation and cellular therapy Vol. 30; no. 2; p. S442
• Main Authors: Devassy, Roni, Collier, Ms. Victoria, Hankins, Mrs. Patricia, Hanna, Richard S, Porter, Ezra, Peters, Alexander J, Grupp, Stephan A., Kadauke, Stephan
• Format: Journal Article
• Language: English
• Published: Elsevier Inc 01.02.2024
• ISSN: 2666-6367; 2666-6367
• DOI: 10.1016/j.jtct.2023.12.635

The recently introduced FACT B10.4 standard has elevated the complexity surrounding data protection and system validation in cell therapy programs. This standard, based on 21 CFR Part 11, outlines the necessary quality measures for systems that are directly under the control of the cell therapy program, including the clinical program and the adjacent marrow collection, apheresis, and processing facilities, and could directly affect patient safety and/or the quality and safety of a cell therapy product. As a result, many centers are grappling with how to properly implement this new standard without hindering their operational flow. To expedite compliance, we developed a streamlined decision tree that assesses whether a system falls within the scope of FACT B10.4 and incorporates a subsequent risk assessment (Figure). We created a REDCap-based tool that incorporates this decision tree through branching logic and captures all required data elements for documenting FACT compliance, including validation and training when necessary. This tool is equipped to capture electronic signatures from responsible personnel and also registers operational details, such as the technical and subject matter lead for each system. Further, we designed a custom R/Shiny application that downloads data directly from the REDCap database and displays an interactive dashboard. This application produces the mandated B10.4.1 systems listing on-demand, ready for review and signature. Our Cell and Gene Therapy (CGT) Informatics team, a data science unit embedded within our cell therapy program, is responsible for maintaining these tools. Thus far, we have successfully captured data on 24 systems, 5 of which were identified as being within the scope of FACT B10.4. These include three high-risk systems which were formally validated. Examples of these systems are a web application that automates engraftment calculations, an electronic donor history questionnaire, and an Excel tool that calculates CAR-T cell doses. We found that the documentation process for low-risk systems within the scope of FACT compliance requires less than 5 minutes of data entry time, thus minimizing operational disruptions. We have developed a lightweight, yet robust and comprehensive, workflow for rapidly onboarding electronic record systems that meet FACT compliance standards. Our approach leverages commonly used platforms like REDCap and R/Shiny, making it easily implementable in other centers seeking to quickly adapt to the new FACT B10.4 requirements.