We have a software application installed on manufacturing computer which will be used to capture weights of finished samples, the s/w is pretty simple with few calculations. I am not able to figure out whether these s/w comes under GAMP 1 or Gamp 3 category?
That seems like a straightforward Cat 3 to me.
- Category 3 – Non configurable software including, commercial off the shelf software (COTS), Laboratory Instruments / Software.
thank you Graham, I wasn’t sure since I compared it to primary database s/w