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Subscribe NewsletterIT Infrastructure and Network Qualification - Introduction and Strategies for Compliance and System Uptime
Product Id
:
600198
Overview: Federal laws and regulations mandate to put controls and measures on a company network to ensure security and data integrity. Examples are 21 CFR Part 11, Sarbanes-Oxley Act, and HIPAA.
With this legislation IT infrastructure and network qualification and compliance become a much more recognizable issue at higher levels of management. However currently there is no official guideline. Until there will be an industry wide accepted approach companies either waste valuable resources because doing too much or take a risk to fail inspections because not doing enough or doing it wrong. With FDA's renewed focus on computer validation and IT systems, industry is looking for advice on how to comply for networks and infrastructure. This seminar will give recommendations and tools for compliant and effective network infrastructure qualification.
With this legislation IT infrastructure and network qualification and compliance become a much more recognizable issue at higher levels of management. However currently there is no official guideline. Until there will be an industry wide accepted approach companies either waste valuable resources because doing too much or take a risk to fail inspections because not doing enough or doing it wrong. With FDA's renewed focus on computer validation and IT systems, industry is looking for advice on how to comply for networks and infrastructure. This seminar will give recommendations and tools for compliant and effective network infrastructure qualification.
Reference material for easy implementation:
- Example: Network Infrastructure Qualification Plan
- SOP: Risk Based Qualification of Network Infrastructure
- SOP: Qualification of Data Centers
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
Who will benefit:
- IT managers and system administrators
- QA managers and personnel
- Analysts and lab managers
- Validation groups
- Validation professionals
- Training departments
- Documentation department
- Consultants