Documents & Whitepapers

Customer Case studies, Technical Resources and Data sheets

Case studies

Case studies highlighting TrakCel's capability in customer environments

TrakCel in use at the Cell and Gene Therapy Catapult

Managing the WT1 T cell receptor (TCR)
manufacturing development process
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Technical & Industry Resources

Learn from the success of others

High-level introduction to TrakCel

Learn how TrakCel integrates and orchestrates every aspect
of your cell therapy supply chain  - giving you the visibility, control 
and the confidence to scale up and scale out.
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Maintaining an Efficient and Safe
Cell Therapy Supply Chain

An authoritative paper on Clinical supply chain safety by 
Dr. Matthew Lakelin 
Chief Scientific Officer 
TrakCel
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FDA Title 21 CFR Part 11
Compliance

Learn how TrakCel provides the necessary controls to ensure product quality, safety and integrity whilst conforming with the FDA's stringent
21 CFR Part 11 demands.
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Meeting HIPAA
Compliance

Learn how TrakCel can help regulated companies enforce strong security policies and mitigate risks around the deployment, maintenance and support of its TrakCel system.
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TrakCel in the wider
Clinical Ecosystem 

This document outlines TrakCel approach to sharing and integration of supply chain information with external systems including
ERP and LIMS systems
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Data sheets

How we work with you to design, deploy and deliver

Validation Support Services

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Compliant Hosting Services

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Training Services

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Technical Support Services

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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.