ABSTRACT
Computerized systems validation (CSV) represents one of several foundational quality systems necessary to ensure the overall integrity of the biopharmaceutical manufacturing, testing, packaging, and holding process — and thereby meet the ultimate goal of ensuring biopharmaceuticals provided to patients are safe and effective. CSV strategies must meet the needs of a competitive business environment characterized by complex and rapidly changing technologies. As such, CSV strategies should be streamlined, yet effective, and tailored to the specific risks posed by individual types of computerized systems. An appropriate CSV program truly adds value to the biopharmaceutical manufacturing process and is not — as is frequently misconstrued — a mere documentation exercise.
