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.
