Day

May 20, 1999
14. Failure to validate the software programs, Shimadzu and _____ that are used to run the laboratory HPLC equipment, during analysis of raw materials and finished products. The _____ software does not secure data from alterations, losses, or erasures. The software allows for overwriting of original data. There are no written procedures for the use...
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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:  https://www.fda.gov/medical-devices/medical-device-reporting-mdr-how-report-medical-device-problems/exemptions-variances-and-alternate-forms-adverse-event-reporting-medical-devices

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