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"Silent validation IQ/OQ" - Pharma customer

Florian_Vogt

Hi all,

we have a pharma customer with many licences. They use the IQ/OQ packages we provide.

Now they want to save themselves some time doing this process for each client individually. Instead, their idea is to do the validation procedure with only one "reference client", and then do the silent roll out to all other clients, without extra validation of each single client.

Anybody with experiences or thoughts on this?

Has anybody ever heard of a customer do this?

Thanks for any answers or hints!

Best

Florian

Accepted answers

MikeD_Anderson

Using a system of record for validation is how everyone I've encountered does it. They have a standard configuration and then use the validation tools we provide (including the customization features) to run a set of predefined tests. If it passes, they push it out to the company as validated. If it doesn't they review the changes and document why they happened and then decide to validate or not based on any perceived risk. I don't think I've ever heard of one checking every single machine... That would just be tedious...

I recall @Chris_Kirchberg mentioning that "validation" is really up to the customer and how they want to manage their validated environment. We provide the tools to make sure that JMP is behaving as we would expect, but implementation is really up to them. So, if they want to have a reference client and validate against that, as long as they can defend the decision in an audit, then it's their call.

Best,

Emmanuel_Romeu

I recently discussed the topic with the guy responsible for validating new versions of JMP at Beckman-Coulter. They do a risk assesment wich is filled as a document registererd and available for auditors (key is traceability of document/version, reviewers comments, approval). They define what is the typical computer configuration (there could be various configurations not only 1) and test that JMP works on those configurations and document that nothing wrong happened. That's it. Most of the work is documenting (paper work) not testing computer. Testing is just opening and checking that computer does not crash.

All comments

martindemel

have you asked Peter Bewerunge from accantec? he is certified to do validations for pharma companies, may he knows more or can tell if there is an issue with doing so.

Florian_Vogt

@martindemel I am in contact with Peter and will add our solutions here once we have one.

I still was wondering if anybody has experienced how other customers handle this topic. Did anybody have a pharma customer dealing with these kind of tasks?

Thanks

Florian

MikeD_Anderson

Best,

benfrancis

Hi Florian,

Recently had a customer that wanted a list of compliance codes from us. My response (and the advised response for most compliance requests) is explained here: Responding to requests regarding the compliance of JMP

As @martindemel & @MikeD_Anderson hinted towards, we have to politely explain it's up to them!

Ben

Florian_Vogt

Hi @MikeD_Anderson ,

thanks a lot for your reply - that helps me a lot.

Actually the customer does the IQ/OQ procedure on every machine (they have more than 80), which they find of course very tedious. That's the reason behind my question.

Ok, that also matches to what I learned so far: it is up to them to decide what/how they do, as they have to get through with it in any audit (regulatory/customer).

Thanks again

Florian_Vogt

Hi @benfrancis ,

thanks for your reply. You are absolutely right, it is up to them to do the work. I might have expressed myself misleading. I do not intend to offer them help doing it.

I just didn't have an answer to the question whether it is necessary for them to do the validation on each single machine (they have more than 80 licenses). Seems not to be necessary. And as @MikeD_Anderson mentions, it's up to them to decide what and how they do it as long as they are able to get through their audits.

Your resources are helpful as well - thanks!

Best,

Florian

Emmanuel_Romeu