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.”

Upcoming Training

62304, FDA, and Emerging Standards for Medical Device and HealthIT
Planned Instructors:  Brian Pate, John F. Murray, Jr
Location: Sunnyvale, CA, USA
Dates:  February 4-6, 2020

QSS Software Validation
Planned Instructors:  Brian Pate, John F. Murray, Jr
Location: Boston, MA, USA
Dates:  June 2-4, 2020

To pre-register and get info on deep discounts or if you have questions, email training@softwarecpr.com

Corporate Office

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