Recipient: Verichem Laboratories Inc.Product: clinical chemistry reference materials for in-vitro diagnostic (IVD) use Date: 12/16/10 1. Failure to validate the design under defined operating conditions and by using initial production units, lots, batches, or their equivalents, as required by 21 CFR 820.30(g). b) Your firm failed to perform design validation for the data analysis software...Read More
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John is currently providing telephone and face-to-face meetings to discuss: Cybersecurity, Part 11, 483 Response, design controls expectations for software documentation, and other topics.
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