Inquiry about GAMP Software Category for JMP Software

[#1]

Dear JMP Support Team,

We are an FDA-regulated (GxP) pharmaceutical company and are currently preparing the validation documentation for our analytical software systems.

As part of this process, we are trying to determine the correct GAMP software category for JMP Software. However, we have found differing opinions within the industry: some consider JMP to be Category 3 (Non-Configured), while others classify it as Category 1 (Infrastructure Software), depending on how it is deployed and used.

We would therefore appreciate an official statement from JMP on the following:

1. How does JMP (as the manufacturer) evaluate or classify JMP Software under the GAMP software categories — specifically, does JMP consider it Category 1 or Category 3?

2. If possible, could you provide documentation or a formal statement (e.g., a vendor assessment, qualification letter, or white paper) confirming this classification, so that we can support our validation rationale with an authoritative source?

We understand that the appropriate category may depend on the specific deployment and intended use, but your official position would be of great help to our internal assessment.

Thank you for your time and assistance. We look forward to your response.

[#2]

You might get answers here but this is not JMP Suppor. To contact them, I would suggest using [email protected] email ( User Community / Support )

[#3]

JMP "out-of-the-box" is category 3 (non-configured product, COTS), I think.  A JMP script that you use within JMP might be Category 5 (custom application).  

[#4]

Best resources about this topic are at jmp.com/qualitystatement