Warning Letter – Zeus Scientific IVD Part 11 WL

Company: Zeus Scientific Inc.
Date: 3/27/01
Product: IVD test kits
In addition to the above,your firm failed to validate the electronic documentation system used to record corrective action requests (CARs) prior to implementation. The electronic record requires electronic signature,for which there is no timestamp on the record. Also, you failed to certify to the FDA that the electronic signatures are legally binding. We have received your written request,dated February 6,2001,in which you state this system was in validation mode at the time of the inspection. There was no indication during the inspection that the CARs system was being validated. In fact,there was no evidence that a concurrent manual system was in place for recording CARs. Your procedure,SOP-0017 indicated the electronic forms were in effect since July 2000
FDA District: New Jersey District

SoftwareCPR keywords: 21 CFR 11 E

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