If your company is using computer systems in a regulated environment, you are aware that
they must be qualified and validated to demonstrate suitability for their intended use. 
Industry-wide uncertainty still prevails on how to qualify these networked components and
networked systems when a number of computers act as a networked system. 

These systems have been subject to FDA audits, 483 inspectional observations, and Warning Letters. The difficulty?  Little information has been available, to date, on how to deal with these issues…until now.

Best Practices – Network Quality Package has been created to provide a thorough understanding of the qualification of network infrastructure components as well as the validation of networked systems.
Version 3.0, just released, now contains twice the material and
an audio seminar.

This information-filled package provides practical recommendations
on qualifying individual network components and validating networked systems.  Network Quality Package starts with FDA findings during inspections of systems and continues in defining which systems should be validated from an applications point of view.

Finally, the information will guide readers through all qualification tasks starting with
definition and design through installation and operation - to on-going performance control
and change control.

Prices at only $349, Best Practices – Network Quality Package includes:

  • Manual – over 140 pages covers the qualification of networks and validation of
    networked systems
  • SOPs (13)  – for planned and unplanned changes, for people qualification, for risk
    assessment, for PC client and data center qualification, and for access testing
  • Gap Analysis/Checklist – Network Quality, 10 pages
  • Templates (5) for Network/System Characterization (baselining)
  • Regulations and Guidelines – more than 50
  • NIST Guides – 7 on CD
  • Warning Letters/483s related to networks
  • Interactive Video on CD: “Qualification and Validation of Networks and Databases”
  • Audio Seminar: “Network Qualification” (on CD in Binder)
  • On-line Updates for Two Years – requires User ID & Password
  • Validation Master Plan for Equipment, Computer Systems and Networks

For a complete listing of contents, click here.  To learn more about the author, click here.

Best Practices – Network Quality Package is economically priced and includes shipping
and handling, PLUS, two years of on-line updates through a password-protected web site. 
To order online, click here.  You may also call 800.459.3363, Ext 28.

Computer Compliance Made Easy