There are three myths about software validation, says David A. Vogel, president of Intertech Engineering Associates Inc., Norwood, Mass., (inea.com). “The myths are that validation is the same as testing, verification is the same as testing, and verification and validation combined is the same as testing,” says Vogel. “They are not, and validation is not a one-time event. Instead, it takes place throughout the software lifecycle,” he says. His company serves the medical device industry with verification and validation services.

According to Vogel, the FDA says validation includes quality planning, which covers planning for risk management, configuration management, software quality assurance, and software verification and validation among other things. “Safety activities are part of an iterative process that repeat at each phase of the software lifecycle,” Vogel says. He adds that software maintenance includes document requirements, software design records, and user-site testing and maintenance. “Only a small part of software engineering is programming,” says Vogel.