Hi Marion, the validation aspects have always been around, its just the tests and assessments staff had always performed prior to using equipment or processes were mainly in our heads or scraps of paper, rather than being formally documented in a structured way. The Blood Safety and Quality Regulations Act (BSQR) , changed all this (2005) and we all needed to implement proper quality systems- you don't really need to read this document yet. For your overview you could start with the usual transfusion history, improving safety, emergent diseases that affect blood donations, CJD - and difficulty in testing for this- and potential unknown effect this will have on the blood supply . This would lead into the need for robust traceability of donations and then introduce the BSQR and how this ties in with 'quality'- which basically means doing things (testing, teaching, maintaining, checking,... everything)- in the best possible way. Validation is just one of these aspects- to ensure systems are 'fit for use' This ALL leads up to improved patient safety and care.....which is what we are all trying to aim for. Good luck with exams!