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

chapter |44 pages

SDP SOFTWARE DEVELOPMENT PLAN

chapter |26 pages

SDTP SOFTWARE DEVELOPMENT TEST PLAN

chapter |12 pages

SEAP SOFTWARE END-PRODUCT ACCEPTANCE PLAN

chapter |16 pages

SQAP SOFTWARE QUALITY ASSURANCE PLAN

chapter |32 pages

SVTP SOFTWARE VALIDATION TEST PLAN

chapter |14 pages

IDS INTERFACE DESIGN SPECIFICATION

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