August 11, 2000
Company: Baxter Healthcare Corp. Date: 8/11/00 Product: Drug Products Failure to conducted and/or document input/output checks of the _____ computer system. [21CFR211.68] In addition, we further request details regarding steps your firm is taking to bring your electronic cGMP records into conformance with the requirements of 21 CFR Part 11; Electronic Records; Electronic Signatures. Part...
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What’s New

FDA:  Exemptions, Variances, and Alternate Forms of Adverse Event Reporting for Medical Devices

Manufacturers, importers, and user facilities can request an exemption or variance from any or all of the medical device reporting requirements in 21 CFR Part 803.  Read more:

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