What do you include in a IQ

COMPUTER SYSTEM VALIDATION (CSV) SOFTWARE VALIDATION DOCUMENTATION
1

Let me know what you think of my list

Installation Qualification should cover the following but is not limited to:

Inventory Checks (Hardware, Software, and Data Load)

  • Make/Model/Serial Number
  • RAM and Disk Capacity
  • Operating System Version, Firmware Version
  • Installed Software version

Equipment Interconnection Checks

  • Equipment Interconnection
  • Cable/Wiring Specification
  • Correct connection and operation of system device/peripherals
  • Diagnostic Checks

Network Checks

  • Hub/Bridge/Router etc., make model serial number
  • Cable/Wiring Specification
  • Network Naming Convention
  • Node Identification
  • Data transmission Checks

Operating Environmental Checks

  • Power Supply Parameters
  • RFI, EMI tolerance
  • RH, Temperature
  • Hazardous area installation standard
  • Physical security of computer rooms and networks

Field device/instrument checks

  • Instrumentation identity and Type
  • Confirmation of installation standard
  • Calibration details
  • Configuration parameter records
2

In one project I worked on, we did an analysis of the critical components of the system, documented them, and ensured the setup / use was in accordance with the manufacturer’s guidelines. For example, one of the critical components was a device to measure an offset point. The tolerance was pretty tight so we showed that the component was capable of measuring to that degree.

3

Thats a good point yodon, it’s practically impossible to apply

a standard that will fit all systems in terms of OQ testing a different systems/equipment will have different ctirical components.

frank your list is good though and as you stated it is not limited to the heading provided

4

I would add to the title “for a SCADA or DCS”

Also, a lot of the networking checks are satisfied by Network Qualification.

RFI/EMI tolerance? I hate this test!! So the specifications call for this? Temp/humidity? what if it is in an office? Still document?

Sorry, don’t mean to pick but to me an IQ can’t be cookie cutter, it has to be based on specifications and then the specifications should be analyzed for risk.

Last, I think a lot of this documentation should be completed by the commissioning team. Maybe I am off base, but it seems like a lot of work for a pile of documentation that will never be used nor see the scrutiny of an audit.

I fully understand the rationale for all this documentation, but I have yet to see it used. Maybe other companies rifle through volumes of IQs for change controls, I just haven’t seen it yet. Maybe I’ll post my rant on validation verifying all Quality systems.