SQL Server 2019 - Master Data Services - Validation needed?

#1
Hello at all,

we want to transfer some data from our ERP-System to the Master Data Services. There we want to establish some business rules, where allowed people can change some attributes and/or entrys of the master data, for example acitivating a checkbox or entering new data. Afterwards we will transfer it back to our ERP-System, so that the ERP-SYstem does have the updated data. The transferrings will be done daily automatically.

Do we need to validate the Master Data Service, which is a standard functionality of an SQL-Server? And how should it be validated?
Or it is just like validating an excel-sheet? Or do you just have to test and proof that the business rules and the transferring is working? Or only validating the interface to the ERP-System?

Or is it part of the server qualification of the IT? If yes, How should it be qualificated?

What documentation do you need?

Thanks a lot in advance for your advice
 
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Tidge

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#2
I'm reluctant to provide specific advice in this case, but I feel like there are some elements (of what you describe) that may require elements of validation/assurance. I don't anything about your broader policies and what they allow/require, so the following are just the corners where I would shine some light and a description of what I expect to see.

The specific details of the SQL server certainly ought to be documented, if only because it may become necessary to rebuild, repair, or replace it... just like any other element of infrastructure,

For the parts of the process that rely on automated features including the interface, you ought to have evidence that they are working as intended. If the business rules are established and never change those should be documented. If the data is manipulated by humans, you may want to investigate controls for the risks that data is unintentionally changed... even if this is just a business risk. I am dealing with an unfortunate CAPA which is basically "I am an important human and made a mistake, why did the tool allow me to make a mistake?" Think blaming an automobile because the driver exceeded a posted speed limit.

I don't believe that you are responsible for being the quality control for the mechanics of the underlying SQL database. You should have enough information to believe it is meeting your needs. It is possible that there may be some elements of (integrity of) electronic records involved, especially if data is moved into a second system for manipulation and then moved back to an original system. I don't have enough information to make an assessment... but generally: if you are familiar with how clauses of 13485 map to US regulatory requirements (e.g. 21 CFR 820) it is possible to make a regulatory compliance assessment about the (compliance-based) need to implement what kinds of controls (as described in 21 CFR 11). Of course, you may want to implement similar controls for business reasons, independent of the compliance question.
 
#3
Hello Tidge,

thanks for your input.

I discussed it with the colleagues and there are some points which needs to be validated and documentated.

As the Master Data Services does have an Audit-Trail and a concept of user rights which differs from the user rights of the ERP-System, these features/points must be at least developed, documentated and verified. So that the user cannot change different things than they should. As well it should ve reviewed periodically
 

Junn1992

Quite Involved in Discussions
#4
Just want to add on, that data backup also has to be shown somewhere. This is important for yourself and the auditors. In the event the maser data service is down, do you have an offline version to work with temporarily? I had a situation in a previous company once when the ERP was down for half a day (global network outage), we couldn't do any work at all. But back then the company wasn't ISO certified, in an ISO certified environment I would expect this to be more of a documentation issue.
 
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#5
Disclaimer: I know nothing about your way of work, tools, or company, but from the top of the head and imagining a setup as you described it, I offer my 2 cents below.

The very least I'd go for is the following:
- recognize the use cases of the tool for your company
--- storing entered data
--- returning values from the database
--- data access
--- data protection
--- keeping the audit trail
--- denying attempts to corrupt the history of stored data and/or transactions
--- syncing data between the DB and ERP (and vice versa)
--- ...

- recognize the risks emerging from the use of the tool
--- data is not stored correctly
--- tool returns incorrect values from the database
--- users can access data they're not supposed to
--- history of data can be manipulated/corrupted
--- interface between the DB and ERP fails (brings up a whole new cluster of risks) ...

- prepare test cases to test the above mentioned and prove that the tools perform as intended.

Make sure / prove / record that the tool is installed per manufacturer's guidelines (IQ), the supporting OS is adequate ...

Record and analyze known issues of the tools.

Is the "automatic sync" going to be done by a third software, or is the ERP or DB tool going to do this? In each case, think about what could go wrong with this setup (databases access, data translation from one DB to another, communication fails ...) and test it.

Also, as Junn1922 mentioned above, think about the "server down" and "communication down" situations, data sync after the communication is restored, backups ...

It seems like a wide array of things to be done, but then, you want to be sure the setup works and you've covered the use cases and foreseeable risks.

Cheers,

Damir
 
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