R
Hello,
was hoping that someone could give me some advice.
i'm currently sitting in for a val manager. I'm going over the program and i see several pieces of software that have been assessed as needing commissioning and uRS's only.
These pieces of software are COTS, GAMP category 3, so while i agree they are simple, I have never had the experience of simply commissioning software. Instead, I've seen very simple IOQs, or even checklists, but they were always qualification.
Even one of the spreadsheets used (simple calculations) are listed as needing commissioning only.
Also, one more question: if the software is an indirect GMP impact, does anything need to be done aside from ensure that it is in the System register for the site?
Thanks so very much in advance!
was hoping that someone could give me some advice.
i'm currently sitting in for a val manager. I'm going over the program and i see several pieces of software that have been assessed as needing commissioning and uRS's only.
These pieces of software are COTS, GAMP category 3, so while i agree they are simple, I have never had the experience of simply commissioning software. Instead, I've seen very simple IOQs, or even checklists, but they were always qualification.
Even one of the spreadsheets used (simple calculations) are listed as needing commissioning only.
Also, one more question: if the software is an indirect GMP impact, does anything need to be done aside from ensure that it is in the System register for the site?
Thanks so very much in advance!