We recently purchase an advanced recorder from Honeywell, specifically the Minitrend® QX.
Since this equipment has a software we need to categorize the system based on GAMP 5 categories. I consult with different peers in the plant, but most of them have different opinion (some of them believe is 3 and others 4). The configuration currently performed in the software is to assign a name to the inputs (the system receive 4 inputs 4 to 20 mA) defined users and privilege, define alarm limits and use the default display provided by the system. All of the above configuration are already available in the system, in other words no special configuration was performed.
I would like to confirm the category of the system based on the above information, I believe that the system should be classified as category 3.
thanks
Basic standard configuration would go with category 3.
Examples are:
naming of labels: in your example input channels
standard parameters: in your example the alarm limits for standard system functionality
These configuration parameters would be recorded in the configuration file or log book depending your system management SOP. In this SOP you could also define simple ways to change these parameters without using fully fledged change management procedure.
For category 4 you would classify systems, which allow complex implementation of workflows, like LIMS or ERP.
All lab equipment, HPLCs etc. would also go into category 3.
Ideally your CSV SOP would define this kind of classification in the first place.
Hope this helps and will be followed by a majority of experts.
Thanks for the response, this clarifies the post.