shahnaz khan1 wrote:
Hi,
If a very basic instrument (for e.g AAS- not connected to any computer but with touch screen display function) generates result for assay which are not stored any ware in software data base but printed out straight from display screen of the instrument meeting data integrity requirement?
You have to assess what kind of data is generated with your AA. At the minimum you have to make sure the paper report generated is a complete replicate of the original electronic record. If it contains dynamic data that cannot be printed, then you cannot use the system for GMP purpose.
AAS generates quit a bit of metadata and dynamic data. You can try to spin your system as a category I system to an inspector. I dont see how an knowledgably inspector could accept it.