Adding a printer to a validated system


I am dealing with an overzealous (imo) Quality Assurance Department that
believes that adding a “like-for-like” Windows compatible printer to a
validated system requires validation of the new printer.

If the system requires a Windows compatible printer and I provide one,
all that I think I should have to do is to generate a windows test page
and a sample report from the system. If the windows test page comes out
and the report looks the same as an existing report, isn’t that enough?

This is a local printer on a locked down non-networked system. c’mon.

What would you guys say if confronted with this request?


If there are no requirements in the system for it to be able to print in
a specific way that maybe particular to the brand of printer you were
using, then I don’t see any reason to validate.

That said however, we used to print MedWatch forms that used a
Postscript file. Every time we purchased a new HP printer, we would
print the form to make sure there were no problems with it.

I think it comes down to what you are doing.

I wish this was the case but I can tell you from first hand experiencethis is not always true.To make a very long story short.The budget dept. tired to have us use a high volume “off-brand” printerto replace an HP printer we were using to print batch records and otherGMP documents. We found if you printed multiple copies of largedocuments the “off-brand” printer would drop a character, a word, a lineor a paragraph in totally random locations in the documents, but neveron the first copy and never in the same place. These were standard MSWord documents using Word to print and we never saw the problem with theHP printer. The strangest problem I have ever seen with a printer. Thevendor changed printers/drivers/memory etc and never did solve theproblemI have also had some print drivers not work well with the application.The print driver can also effect the document layout. We had some GMPdocuments where the layout/page breaks would change depending on thecurrent default printer when the document was opened. This was a veryannoying problem.If you don’t change vendors, drivers etc your risk is less but asanything in the GMP world you need to balance the risk vs. the effort.You also have issues if you are using things like barcodes, specialfonts etc. Does it require a new print driver that might effect theapplication? Does it meet the requirements of the application? You needto know how it is used to make the call on the level of validationrequired. This should be part of the change control process to evaluatethe change/impact and specify the required level of validation.