New edition of a reference that provides a logical, organized and coordinated effort at defining a software quality assurance program for healthcare manufacturers. The information in this volume comprises a more concrete formalization of the software engineering policies, SOPs, and project documents and thus can be used as a companion reference to the first edition. In addition to guidance for generating documents and their contents, it contains templates that help establish the documentation. Documents cover methodology; process; and software project planning, requirements and design, hazards and safety, testing and verification and validation, configuration management, and process improvement. Presented in a three-ring binder. Annotation c. Book News, Inc., Portland, OR (booknews.com)
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 existing software engineering policies and SOPs within their organizations. They can also use the project documentation examples as presented within this volume. In this second edition, all templates have been revised and several new templates have been included.