Case Study: University of Utah Cell Therapy achieves 21 CFR Part 1271 compliance with Ideagen's Q‑Pulse

University of Utah Cell Therapy Facility streamlines its quality processes for 21CFR Part 1271 compliance

The University of Utah Cell Therapy & Regenerative Medicine Facility is an FDA-registered stem cell processing lab that supplies HCT/Ps for local hospitals. Facing strict requirements under 21 CFR Parts 11, 1270–1271 (particularly Part 1271/cGTP), the facility needed an electronic quality management solution to replace manual document control, better track revisions, and automate deviation and non-conformance record-keeping to reduce time, effort and compliance risk.

They implemented Q-Pulse from Ideagen as a centralized compliance platform. Q-Pulse provides controlled document storage, automatic versioning and messaging notifications, automated deviation/non-conformance tracking, and audit-ready electronic records, enabling faster change control, point-of-need access, and maintained compliance with 21 CFR Parts 11 and 1271 while reducing administrative burden and improving QA/QC readiness.

University of Utah Cell Therapy