: Category 2 (firmware) was removed in GAMP 5 (1st Ed., 2008) and confirmed in GAMP 5 2nd Ed. (2022). Most firmware is now treated as Category 3 or 4.
The focus here is on User Requirements Specifications (URS) . Since you can’t change the software, you simply need to prove that the "out-of-the-box" functionality meets your specific needs and that the vendor is reputable. Category 4: Configured Products gamp software category