After years of dialogue between the U.S. FDA and industry, the agency’s long-awaited draft guidance for computer software assurance (CSA) for manufacturing facilities signaled a new, less cumbersome ...

Still, says Shari Pfleeger, a computer scientist for Rand in Washington, DC, mathematical methods like Lynch and Garland’s have a place in software design.

The shift to Computer Software Assurance (CSA) provides opportunities to enhance compliance through critical thinking, risk-based assessments, and au ...