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.”

Software Verification

Do you have gaps with IEC 62304 compliance or with FDA expectations for software verification?  We can help you quickly remediate gaps with unit verification including unit testing, code review, and static analysis, as well as integration and system verification testing.  Call us at 781-721-2921 or email office@softwarecpr.com to start a conversation.  We can provide estimates of cost and support your development tools.

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