Computer System Validation - Migrating to SAP

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Emma2015

#1
Hi All,
We are currently changing from our old computer system to SAP. I know we need to validate the system but unsure of exactly is entailed. I have asked the vendor too provide us with a validation document but looked at me as if it was alien. From what I understand this is a document that details our scope, the standard procedures, how it is going to be implements etc. Can someone please help me if I am correct and explain how I can obtain this from our supplier. Many Thanks Emma
 
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PaulJSmith

#2
Welcome to The Cove, Emma!

Based on my past experience, good luck getting anything helpful out of those people.

Besides, you really need to validate that the software is working correctly in your system. I don't think that SAP or their vendor can offer you any pre-existing document to do that for you.
 

ScottK

Not out of the crisis
Staff member
Super Moderator
#3
I've worked with SAP in the past and my company basically had their own corporate SAP support staff who developed the validation for the modules we used.
We got nothing from SAP themselves other than training and technical support.
 

yodon

Staff member
Super Moderator
#4
My experience is in medical devices so your requirements may differ.

But in general, validation needs to be done on your system anyway. If the vendor has some testing results, you may be able to get some lift but it would need to be supported.

The first step is to define your requirements for use. If you're not using all the features available, there's no need to include that in the validation.

The requirements form the foundation for the testing efforts.

You may also want to consider security and roles. (This is where it's especially important to demonstrate on your system since you may set things up differently than the vendor).

Another consideration is to demonstrate that it's installed correctly. The vendor should be able to provide specs on the server requirements, network requirements, etc. There may also be client-side parts to consider. You can document that you have installed the system correctly (here again, there may be some security aspects to consider) and that your network is properly configured to support the system. Also, you may want to get a list of known issues with the software and make an assessment as to whether or not this will impact your operations.

You may want to do some robustness assessments. Will the installation be able to handle the maximum load expected? Are there security vulnerabilities?

Realize, though, that validation goes beyond testing. Validation is a state. Once you achieve the validated state, the controls need to be in place to ensure you can stay there. New versions will roll out, patches will be applied, etc. These need to be considered for re-validation activities.

That's about it in a (very tiny) nutshell. It's not a trivial effort but it's a good investment to provide reasonable assurance of a reliable system.
 

Joe Cruse

Mopar or No Car
#5
We didn't go with SAP, but recently went live with an ERP system. Validation, for us, meant having a "practice" environment, where all the core developer team for our company built a set of practice data in the practice environment, and did testing for several months with the environment. Once all sections were verified as working with the test data, the built system in the practice environment was copied over to the "Live" environment, and all current data from the old systems were imported to the Live system at the end of the final month of operations under the old systems. We then started a new month, going "live" with the new ERP.
Naturally, we found the need for new pieces to the system, as we matured over the next several months, and even now, after almost 2 years of use. When new things are required, it is built in the "practice" environment, and the users test it there until it is deemed fit for use. The IT Mgr then copies that new piece into the "Live" system for use.
Pretty easy to document and then demonstrate to an auditor; VERY time consuming to do though.

Good luck and best wishes! I don't wish implementation or Go-Live on my worst enemy.
 

reynald

Quite Involved in Discussions
#6
Hi All,
We are currently changing from our old computer system to SAP. I know we need to validate the system but unsure of exactly is entailed. I have asked the vendor too provide us with a validation document but looked at me as if it was alien. From what I understand this is a document that details our scope, the standard procedures, how it is going to be implements etc. Can someone please help me if I am correct and explain how I can obtain this from our supplier. Many Thanks Emma
Validation would focus on 3 items:
1. List of what it should be able to do - these are the functions you paid for, or at least the vendor committed to deliver. Make sure they are working as intended (i.e. notify low inventory items, create report for system inventory, etc)
2. List of things it should not be able to do - these are the high risk failures that you want to prevent. Make sure they don't happen (i.e. a staff can approve a thousand $ order. If this is a big no, test and make sure you the system does not allow you to do that)
3. Data Integrity - run a report and compare output with your current system. They should agree with a certain tolerance. If your old system says you have 1,000 units of inventory then SAP should give the same figure. If they don't agree then at least show that what SAP gave is the real figure and the old system is wrong.

These three are tedious to carry out. In fact making a list alone for 1 and 2 is tedious by itself as you need to get as many perspectives as possible. As for item #3, be patient and stand your ground. Assume SAP is wrong when values don't agree - unless of course conclusively proven to be the other way around.
 
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