IT Infrastructure and Network Qualification
Areas Covered in the Session:
Laws, regulations and guidelines- 21 CFR Part 11, HIPAA, Sarbanes-Oxley
The FDA Industry Guide: Cybersecurity for Networked Medical Devices
The GAMP/ISPE Good Practices Guide
The IVT proposed NIQ standard
Principles of network infrastructure qualification
Compliance concepts for infrastructure vs. networked systems
Configuration management and change control as the most important network qualification steps
Qualification of PC clients, servers, data centers
What and how much to test with the risk based cost/benefits in mind: network components, servers, PC clients, applications, initial vs. on-going testing
How to ensure highest system uptime with on-line monitoring tools
Documentation requirements
Going through a life inspection
source
For IT Infrastructure service, visit AsiaPac Singapore
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