Cobe 4/16/96 Hemodialysis
10. Failure to have adequate checks designed and implemented to prevent inaccurate data output, input, and programming errors when automated data processing is used for manufacturing or quality assurance purposes, as required by 21 CFR 820.195. For example, the computer search process for complaints by serial number is not designed to detect improper data entries, and the $$$ program has not been validated to show it properly selects $$$ PURGED TEXT, OMITTED $$$.
