FDA guideline for QA in blood establishments

FDA CBER “Guideline for quality assurance in blood establishments” issued July 11, 1995.This guideline applies to the Blood Establishments but has information that can be useful to blood bank Computer System manufacturers. The purpose of this guideline is to assist manufacturers of Blood and blood components, including blood banks, transfusion services, and plasmapheresis centers, in developing a qualityassurance (QA) program in their effort to be consistent with recognized principles of quality assurance and current good manufacturing practice (CGMP).

CSV Training Course

Learn FDA expectations for software validation for computer systems, quality system software, manufacturing and production process software, and engineering tools. Email training@softwarecpr.com for more info.

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