G&B Electronic Designs Limited

RecipientG&B Electronic Designs Limited
Product: Tracklt and NicoletOne Ambulatory Electroencephalograph Recorder devices

Failure to assure that when computers or automated data processing systems are used as part of the production or quality system the manufacturer shall validate computer software for its intended use according to an established protocol, as required by 21 CFR 820.70(i). For example, electronic records are used, but there was no software validation. No procedures are established to validate for its intended purpose the Microsoft Word or Microsoft Excel software used in creating and maintaining nonconformance records, product return records, internal audit corrective action records, or preventive action records.

We have reviewed your response and have concluded that it is inadequate because off-the-shelf software must be validated for its intended purpose. You have stated that a review will be conducted of the existing forms and an implementation of a new record control system to meet FDA requirements will be pursued. A new system may not be necessary; however, no procedures have been submitted for review and no timetable for corrective action and response was indicated.

FDA District: CDRH

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