Category-2 Systems in GAMP 4

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

Hi,

Can anybody do let me know where the CAT-2 systems from GAMP 4 has been merged in GAMP 5? Some people say it has been moved to CAT 3 & CAT5 and some say its been moved to CAT3 & CAT 4.

Which one is correct. Can you give an example for the same or can refer the same in GAMP guideline somwehere.

Regards
Sourav

2

Hi Sourav,

a Firmware, former Cat 2 in GAMP4, is treated in GAMP5 in Category 3, 4 and 5.
Categorization depends whether firmware is non-configurable (3), configurable (4) or customized (5).

BR
Adrian