Applications across the cell therapy supply chain
TrakCel's process-based design and configuration means you can design complete coverage for any user, partner, process or event right across the cell therapy supply chain. This extensible approach allows you to implement and standardise every process, in any order, and at any time and unify your supply chain visibility and reporting.
Therapy Owner
Therapy Owners and Trial Sponsors and Licence holders can design, integrate and report on the entire global supply chain with exacting detail.
Distribution
& Logistics
Reduce distribution and logistics risk with real-time monitoring of shipping including excursion reporting and real-time alerting.
Manufacturing
Configurable workflows, scheduling notifications and inventory management are some of the many features that enable manufacturers to retain control of the production processes during scale up.
Medical Centre
TrakCel has everything that Medical Centre professionals need to capture and record data, schedule collections notifications, generate labels and schedule treatment notifications.
Regulatory compliance and validation
Designed to meet FDA, EMA and PIC/S validation requirements
Manage compliance in line with regulatory requirements, with instant access to each patient's electronic audit log. TrakCel's implicit orchestration, traceability and reporting capabilities allow you to proactively manage and meet quality requirements far more effectively and efficiently than paper-based best efforts.
This is a subset of the regulations and statutory obligations that the TrakCel platform is designed to meet. Additionally we provide support during the requirements gathering and validation project phases. Our experts will perform regulatory reviews and science-based risk assessments to ensure you remain compliant. Our validation processes are based on FDA and PIC/S guidance.