Support in creation of product and software requirements and testing strategies for a blood donation and transfusion module as part of a laboratory information system.
Supplement
The blood donation and transfusion module is being audited by regulatory authorities. The client has to prove the existance and correct management of product, software and customer requirements. PTA is able to support the client in each phase due to extensive experience and knowledge in this field.
Subject description
Blood donation and transfusion is being audited quite rigorously due to high patient risk. Traceability in requirement and change management and testing of new and modified functionality is crucial to a sucessful audit.