Guideline for Val of Blood Establishment Computers

Draft Guidelline for the Validation of Blood Establishment Computer Systems

“The purpose of this guideline is to assist manufacturers of blood and blood components, including blood banks and plasmapheresis centers, in developing a computerized system validation program consistent with recognized principles of system development methodology and quality assurance that are current good manufacturing practices. This is not intended to be a guideline for software manufacturers who may be subject to other guidance and reqirements.”

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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