Day

August 6, 2015
Mylan.Product: pharmaceutical manufacturing facility Date: 8/6/2015 Your firm failed to exercise appropriate controls over computer or related systems to assure that only authorized personnel can change master production and control records, or other records (21 CFR 211.68(b)). Your Siemens computer-based BMS and NVPMS do not require passwords to access the network and servers. Your contractors?...
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Software Risk Management

Medical Device Cybersecurity

Software Verification

IEC 62366 Usability Process and Documentation

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