Nothing software specific in this guidance, Manufacture-of-Blood-Components-Using-Pathogen-Reduction-Device-2021, but in the future one might envision that the validation and quality control could be automated by software. Purpose of the document is to provide guidance to establishments that collect or process blood and blood components, with recommendations for implementing a pathogen reduction device for the manufacture of...Read More

This topic provides educational checklists related to several standards and regulations. SoftwareCPR checklists are available to paid subscribers of www.softwarecpr.com by using their login. These are only intended for use by those experienced in the related regulations and standards and are not intended to be used blindly as there may be significant interpretational ambiguities and...Read More

While FDA regulates Blood Establishment Computer Systems (BECS) as medical devices as well as regulating the blood establishments themselves, many other countries take a different approach. In Canada the blood establishment is regulated. Computer systems used in donor establishments are not considered medical devices and are regulated through the establishment licensing process. Unlike with the...Read More

While FDA regulates Blood Establishment Computer Systems (BECS) as medical devices as well as regulating the blood establishments themselves, many other countries take a different approach. According to the Danish Competent Authorities the European Union (EU) approach is that equipment for blood banks including transfusion and information systems with clinical data about the donors, blood...Read More