ABSTRACT
This work provides not only guidance for generating documents but also templates that can be used to establish the documentation for a software quality assurance program for healthcare manufacturers. Readers can use the policies and guidelines as presented, modify them for use within their organizations, or use them to compare and contrast with any
TABLE OF CONTENTS
part |2 pages
RTM REQUIREMENTS TRACEABILITY MATRIX
part |2 pages
SFMEA SOFTWARE FAILURE MODES AND EFFECTS ANALYSIS
part |2 pages
SCAR SOFTWARE CONFIGURATION AUDIT REPORT