computer validatio

Warning Letter: Failure to validate computer software (ucm377116)

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Failure to validate computer software for its intended use according to an established protocol, as required by 21 CFR 820.70(i). For example, your firm uses [redacted] to generate, store, and disseminate standard operating procedures, forms, and other records. [redacted] is also used by your firm to generate and store Device History Records (DHRs) and other quality system data. During the inspection, your firm indicated that the procedure titled, “Validacion del software utilizado en el sistema de calidad, GC-E-07-49, Rev. 00,” dated March 14, 2011, states that validation is concentrated on software and documents used in the quality system since there is no software used in your firm’s manufacturing equipment. However, your firm could not produce any evidence to demonstrate that the software programs were validated for their intended use.

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