Which category s/w is it?

COMPUTER SYSTEM VALIDATION (CSV) GAMP® 5 - GAMP® is owned by ISPE
1

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?

2

Hi @larryhack40

That seems like a straightforward Cat 3 to me.

  • Category 3 – Non configurable software including, commercial off the shelf software (COTS), Laboratory Instruments / Software.

Many thanks

Graham

3

thank you Graham, I wasn’t sure since I compared it to primary database s/w