June 14, 2000
The computer software your firm uses to determine metals analysis is deficient. It has no security measures to prevent unauthorized access of the software, no audit trails, and data can be copied or changed at will, with no documentation of the copying or changes. Your procedures do not require the documentation of calculation or entry...
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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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