Resources for JMP/ JMP Pro Software Validation (tailored to HLS Customers)Many of our customers, namely those in the Health and Life Sciences (HLS), e.g. pharma, biotech, medical device, analytical testing, healthcare, reach out to us looking for either a "software validation package" or some sort of "certification" to particular industry-specific regulatory standards or guidance's (namely those published by FDA or ISO).
Each request should be handled on a case-by-case basis, but generally as minimum, we can reference our Quality Statement | JMP page.
We can also state that since we are primarily a software provider (and not a statistical consultancy, independent of or associated with any particular industry specialization), we do not do audits with external regulatory agencies, nor do we hold any external quality certifications. Therefore, we are unable to provide said certifications or a documented software validation package.
Re: Resources for JMP/ JMP Pro Software Validation (tailored to HLS Customers)Thanks, @PatrickGiuliano.
Before sending that to anyone we need to check with Product Management and Legal to make sure we're all comfortable with that information in that formal way.
I, for one, am concerned with making a recommendation to a single, specific third-party. We usually want to maintain some distance and recommend more generally.
@Daniel_Valente who in PM can help review this?
Re: Resources for JMP/ JMP Pro Software Validation (tailored to HLS Customers)Per discussion with Wendy Murphrey on 01/06/25:
- Probably best not to send company information on letterhead. It's not typical for us to put anything on letterhead as a support organization (TS).
- Probably best not to send information in a docx format (would be better in PDF format).
- Changed to self-contained support note WITHOUT the attached document, where it can reside internally here.
Re: Resources for JMP/ JMP Pro Software Validation (tailored to HLS Customers)Note that currently (as of 05/21/25): Michael Crotty maintains the OQ tool (NIST Framework) and Bob Hickey the IQ tool available here: Quality Statement | JMP
