Wireless System Validation

COMPUTER SYSTEM VALIDATION (CSV)
1

Hi,
I have a query relating to the Validation of connecting a wireless hand held device (which is a COTS system) to our MES system.
This would add a few areas of concern for me as Validation Engineer on the project:

Purpose of the Device: Measurements wireless device that sends a result to a receiver and is displayed on the PC

  1. Adding an open device to the network
  2. Risk of connecting the device to the Qualified MES system
  3. the main concern is that there are other devices being used as the same time and ensuring that the correct device collects the correct information and passing that information out to the MES system.

Is there anything else of concern when validating a wireless device? or using a open device on a closed network?

tks,

2

Here are a few links from the FDA website. I don’t know if your target market is in the US but I think they’re generally based on sound principles:

http://www.fda.gov/MedicalDevices/ProductsandMedicalProcedures/ConnectedHealth/WirelessMedicalDevices/default.htm

http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm077210.htm

Should give you some things to think about, at least.

3

Hi yodon, thanks for your reply & appreciate your help.
However, I am looking more like adding a scanner / barcode reader to a manufacturing system. Thy scanner will send results via wireless/ Bluetooth feature to the manufacturing systems.
So it’s the connection between the scanner & electronic manufacturing system that I am interested in validating / qualifying

4

Oh, ok, sorry I misunderstood.

Some of the testing in the FDA guidance may still be applicable - will other, similar devices interfere with the communications (do the barcode readers pair properly - and maintain pairing with several devices in the area, etc.). If there are multiple scanners in the area and confirmed reads / stores give audible feedback, there may be some risk that operators hear the audible from someone else’s reader (presuming operator in the loop - if auto-scanning, there are other potential risks).

As you probably already know, general barcode risks are no read or misread. You just add the risk of data corruption via the wireless interface as part of the risks. Just think about what could go wrong and verify that it doesn’t cause problems…

Regarding open / closed systems - are you referring to 21CFR Part 11? If so, I don’t think adding a barcode reader would drive such a decision.