protocols.io | University of Rochester case study
TraCe-bMPS: Advancing reproducible FDA-facing
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How a tissue-chip research centre built structured SOP governance to prepare its work for regulatory review.

Discover how the University of Rochester’s TraCe-bMPS turned everyday lab practice into documentation ready for regulatory scrutiny. Understand why novel approach methodologies require clear, controlled documentation. Inside, you’ll find:
Why novel approach methodologies need rigorous, versioned documentation
How informal lab practice became auditable, shareable SOPs
Results from three independent runs following the same protocol
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From informal lab practice to regulatory-ready SOPs
The challenge
Growing collaborations across academia, industry and external testing sites meant procedures had to be consistent, controlled and ready for regulatory scrutiny.
The Solution
Researchers and quality staff now review, approve and version protocols in one structured space, with a complete audit trail.
The Result
Reproducibility confirmed internally over several months and at partner sites, alongside stronger training, onboarding and quality systems.
The goal is reproducibility, very good control, in very specific contexts of use.
James McGrath, PhD
Director, TraCe-bMPS, University of Rochester
