Warning Letter: Failure to validate computer software for its intended use (ucm515403)

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Ofni Systems

Your firm has not performed software validation [redacted]. These programs are used in the Starlight laser product family.

b. The software validation for [redacted] is inadequate, in that the [redacted]. This message occurs when either the maximum voltage (6V) is exceeded, or the actual voltage is higher than the reference voltage associated with the intensity selected by the operator.

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, your firm has not validated the following software used in its quality system:

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