Warning Letter: Failure to validate software (ucm309410)

• Failure to validate the design under actual or simulated use conditions, as required by 21 CFR 820.30(g).
• Failure to adequately document design inputs, as required by 21 CFR 820.30(c).
• Failure to adequately document design outputs, as required by 21 CFR 820.30(d).
• Failure to document process validation activities, as required by 21 CFR 820.75(a).
• Failure to validate software used as part of production for its intended use according to an established protocol, as required by 21 CFR 820.70(i).
• Failure to adequately establish procedures for receiving, reviewing, and evaluating complaints by a formally designated unit, as required by 21 CFR 820.198(a).
• Failure to adequately establish procedures for corrective and preventive action; as required by 21 CFR 820.100(a).
• Failure to adequately establish document control procedures, as required by 21 CFR 820.40. For example, your firm’s document control procedures, QOP-42-01) Control of Documents, Rev. D do not address how to control or identify [redacted]used to download the software in finished devices. These procedures do not have signature requirements that demonstrate documents, such as device history record documents· and design drawings have been approved. The documents are dated, and include the name of the individual approving the documents, but lack a signature. The software used to store the procedures, records and drawings do not have an electronic signature capability.

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