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Quality Assurance

Quality Assurance

Quality assurance is the overarching term used to describe the activities employed to ensure the proper performance of a system. These activities can be classified into three categories: quality control, quality assessment, and internal corrective measures. Typically, these activities work cyclically: quality control is performed before and during the analysis, while quality assessment occurs during and after the investigation. Internal corrective measures are implemented based on the findings...

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Can we assure quality without stifling innovation?

¹Foundation for the Accreditation of Cellular Therapy, University of Nebraska Medical Center , Omaha, Nebraska.

Stem Cells and Development

|December 3, 2014

Summary

Ensuring the safety and efficacy of stem cell therapies is crucial for regenerative medicine. The Foundation for the Accreditation of Cellular Therapy (FACT) has developed common standards to advance cell therapies from research to clinical use.

Area of Science:

Regenerative Medicine
Cellular Therapy
Stem Cell Therapy

Background:

The rapid advancement of regenerative medicine necessitates robust frameworks for ensuring patient safety and therapeutic efficacy.
Current challenges exist in translating novel stem cell therapies from laboratory research to clinical application.

Purpose of the Study:

To outline the role of the Foundation for the Accreditation of Cellular Therapy (FACT) in establishing minimum requirements for regenerative medicine.
To highlight how FACT's accreditation process and Common Standards for Cellular Therapies address unmet needs in the field.

Main Methods:

Development of consensus-based minimum requirements for cellular therapies.
Establishment of the "Common Standards for Cellular Therapies" by FACT.

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Main Results:

Consensus on minimum requirements facilitates the advancement of the regenerative medicine field.
FACT's standards promote patient safety and protect the research environment.

Conclusions:

FACT's accreditation and common standards are vital for the safe and effective progression of regenerative medicine.
These standards aim to accelerate the commercialization of new cell therapies by bridging the gap between research and clinical application.