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September 28, 2015
Unimark Remedies LtdProduct: active pharmaceutical ingredients Date: 9/28/2015 Failure to prevent unauthorized access or changes to data and to provide adequate controls to prevent omission of data. Your laboratory systems lacked access controls to prevent raw data from being deleted or altered. For example: a. During the inspection, we noted that you had no unique...
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IEC 62304 and Emerging Standards Impacting Medical Device and HealthIT Software training course in Boise, Idaho. 3-Day course.

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