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University of Utah Cell Therapy Facility streamline QMS management for 21 CFR Part 1271 compliance

Based at the University of Utah in Salt Lake City, the Cell Therapy & Regenerative Medicine Facility is an FDA-registered stem cell processing laboratory that processes human cells, tissues and cellular-based products.

As an FDA-regulated establishment, the Facility had already implemented controls to prevent the introduction, transmission and spread of communicable disease. However, what they did require, was an electronic solution to maintain and improve the management of quality processes, including document control.

Q-Pulse was selected as it provides the Facility with a fully integrated compliance management solution that helps manage regulated activities such as Document Control, Auditing, and CA/PA Management for 21CFR Part 12871 compliance.

Benefits

  • Compliance with 21 CFR Part 1271 record-keeping requirements as staff can now track and manage deviations and non-conformances automatically, making the process simple, organised, streamlined and efficient
  • Q-Pulse is used as an established centralised repository for controlled documents – appropriate personnel have direct access to secure, up-to-date documentation
  • Document version changes can be tracked, cutting down on the time and effort spent at each stage of the change control process
  • Documents can be immediately reviewed via point-of-need access from email notifications of upcoming or overdue actions. 

We now track and manage deviations and non-conformances automatically, making the process simple, organised, streamlined and efficient. This allows us to maintain compliance with 21 CFR Part 1271 record-keeping requirements.

- Quality Assurance & Quality Control Manager
University of Utah Cell Therapy Facility

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