Stop Validating Computer Systems to Death!
By: Daniel R. Matlis, President
“FDA emphasizes that manufacturers are responsible for the adequacy of the software used in their devices and activities used to produce devices. When manufacturers purchase “off-the- shelf” software, they must ensure that it will perform as intended in its chosen application.
FDA has amended the requirement to state, “When computers or automated data processing systems are used as part of production or the quality system,” for clarification. Software used in production or the quality system, whether it be in the designing, manufacturing, distributing, or tracing, must be validated.”
According to FDA’s Francisco (Cisco) Vicenty, Program Manager, Case for Quality, FDA CDRH, the MedTech industry’s high focus on meeting regulatory requirements versus adopting best quality practices has the potential to increase risk to patients. This compliance-centric approach has resulted in quality issues and has hampered innovation in manufacturing and product development practices. Additionally this single-mindedness has led to low rates of investment in automation and digital technologies. Continue reading