Abstract

[This abstract is based on the author's abstract.]

Organizations need computer systems that are reliable and ensure data integrity and security. Software purchases present a major hurdle to this goal in that all software is defective in some way and software may have been inadvertently purchased that does not meet the organization's needs. In response to these issues, the FDA requires that potential software vendors demonstrate that their systems are able to consistently perform to requirements. The FDA developed guidance documents and industry lifecycle methodologies to assist industry in meeting these challenges. They recommend that the approach to validation be based on a justified and documented risk assessment.