Failure to develop, conduct, control and monitor production processes; failure to review the associated data and documentation for finished devices prior to release; failure to validate processes adequately; failure to establish and maintain procedures for implementing corrective and preventive action; failure to validate computer software adequately; and five other violations.
Failure to validate computer software for its intended use according to an established protocol when computers or automated data processing systems are used as part of production or the quality system, as required by 21 CFR 820.70(i). For example, there is no documented software validation or verification for the software used in the _____ microprocessor, which is utilized in conjunction with the _____ Corporation ETO sterilizer.
