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).

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Our cybersecurity experts are NESSUS Pro Licensed and can quickly remediate cybersecurity deficiencies with your medical device or digital health software.  Planning, requirements, validation, and submissions – we can assist with all.

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