Chromatography Forum

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?

assumption - you're working for a US/EU or JP governed pharma company or similarly regulated industry - then YES!
If there is not much in the way of configuration options, you may be in luck and have a GAMP category 1 device. The data integrity requirement for this is modest - essentially a demonstration that it does what it does in an expected manner, that the data displayed matches the printouts and that there's no easy way to get it to misbehave. Run it, print it, sign it without taking a break. If it has a clock/calendar, make sure they're set properly and keep the thing calibrated.

As you get into more configurable devices that store data, you find yourself in category 3 and start running into 21 CFR Part 11 or EU Annex 11 requirements.

As always, consult your in-house SOPs that govern data integrity and documentation practices.

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.