Day

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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Software Risk Management

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Software Verification

IEC 62366 Usability Process and Documentation

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