Computer system validation

Hello everyone!
I need your help in starting Computer system validation in my company.
We have not yet implemented it but now we want to start it as we have recently implemented SAP.
So please guide me reg how to start it in old setup where systems are being used without CSV.
Whether we also need to validate SAP?
Thanks a lot!

The first step would be to establish a foundation. Develop a Master Validation Plan to establish how you approach validation at your company / site.

The second step would be to define how SAP is used at your site; i.e., requirements. You don’t need to validate every aspect of SAP, only those aspects that your site uses HOW you use them.

The next step is to develop a Validation Plan for the system. This describes how your approach to validation complies with your Master Validation Plan while outlining specifics for the SAP validation.

All validations should be risk-based. So part of the Master Validation Plan would be an approach to assess (and document!) risk for each computer system. I would presume that if you had a failure in the SAP system, there would be a quality impact so it’s likely you’ll WANT to validate it for your use.

Hope that helps.

Please bear in mind that you will also be expected to be qualified to perform these actions. Given you’re asking how to get started, you / your company might not have the expertise needed to take this on. You may want to look for some consulting help to bring you up to speed.

Thank you for replying.
We would actually like to validate SAP in our production as well as QC which can impact the product. So can you suggest how to go about that.
My other doubt is reg the lab instrument softwares like HPLC, GC etc, how we can validate that as we are using them for long time.

Hmm… I thought I did. Develop your user-based requirements - what do YOU require the system to do for YOUR processes. That can certainly apply to production and QC. It would make sense to me to have these as separate sections in your SAP User Requirements Spec but that’s up to you.

Do you mean you have been using them in an unvalidated state for a long time? If that’s the case, you’ll still want to go through the exercise of assessing risk, establishing user requirements, and performing the validation but then you’ll add a step to assess impact of validation results on activities previously using these systems. For example, if you find, during validation, that the HPLC doesn’t do something exactly as you expected (per expected results in your validation protocol) then you would need to assess the impact on product previously produced using this system. It could well be anything from no action required (justified) to a full recall.

Take a step back and ask yourself what’s important about these systems to your company. Then ask yourself how to determine if these systems are supporting those needs. Then take the steps to confirm that, indeed, the systems are meeting your needs.

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@rave04. I think you should try to get support of an experienced consultant. If you want to do it by your own, you will need a long time to get your systems validated. If you got it “validated”, you don`t know if the validation will stand an inspection, I think you should look for a professional who is able to bring you on the right track inclusice coaching that after a while you will be able to do it by your own.

Validating computerized systems like SAP is one thing. Method validation for analysis like GC or HPLC systems is something different. Both kinds of validation cannot be supported here within this forum for sure of cause of the above mentioned reasons.

For computerized system validation you should invest into ISPES GAMP 5 which is a pretty good start point to get an idea about the effort you have to do.

Validation of your systems is one point. Another point is also creation of the related SOPs as part of your quality management system describing how you perform these activities.

Hope this helped a little bit and wasnt too discouraging which I honestly didnt want to.

Cheers gtf

Hi everyone!
Can anyone tell me how I can validate SAP ERP?

The problem is:
Some years ago parent company was implemented the SAP system on our company and fulfilled validation for it (protocols and reports not transferred for us).
Now subsidiary company was bought another company.
And now we need to validate the SAP independently.
How I can do this?
We have risk analysis of design decisions (FS - functional specifications) and have a results of testing of them (end users do it) in a test environment. Can we consider this results as a results of validation of SAP (as a results of OQ)?

I apologize for the bad English!