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.”

Cybersecurity Review

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.

Interested in having a conversation?  Email us to arrange a Zoom meeting or call us at +1 781-721-2921.

office@softwarecpr.com

Corporate Office

15148 Springview St
Tampa, FL 33624
USA
+1-781-721-2921
Partners located in the US (CA, FL, MA, MN), Canada, and Italy.