QMS for Life Sciences
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IT takes on a lot of elements

M

Martijn TVM

#1
I got a small problem regarding IT and QS9000,If a system takes over tasks from certain functions, how can you verify it.

You cannot place the responsibility for providing planning information on the EDI and ERPII system. Placing it with the costumers buyer is also out of the question.


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[This message has been edited by Martijn TVM (edited 23 May 2000).]
 
#2
If you give us a few more specifics we can probably give you some help.

"...You cannot place the responsibility for providing planning information on the EDI and ERPII system..." Why not? I understand ERP (enterprise resource planning) to be software/hardware systems which (often costing millions of $) are supposed to give a company planning information.
 
M

Martijn TVM

#3
It is hard to come up with a specific example, but a situation scetch: The customer's erp system receives an purchase order, followed up by placing an order with our company by EDI it automatically tells them whether delivery is possible for the given date, than our erp system comes into action detecting a shortage of a certain material, it sends an EDI message to our subcontractor together with the requested delivery date, the subcontractor's system tells us whether delivery is possible and a confirmation is send back through our system back to our customer, the customer can receive any problems concerning this order by email automatically upon request.

As you can see there is no direct involvement of personell in any of this. This system is not fully operational at this moment but will be within a month or two.

Normally most of these actions would be performed by a logistics employee, but isn't it strange to give some one the responsebility for something he cannot verifiy except by phoning the customer and subcontractor.

If a phone line drops or an email isn't received our planner gets an email automatically stating that, is that verification enough?

I find things like this a lot like dispositioning of material, document and data control, handling, storage etc. At the moment I give the responsebility for these things to the people who would do them when we would still be using paper, but I'm hoping for a beter solution,

If any body could response to this or has the same problem, just post it
 

Marc

Captain Nice
Staff member
Admin
#4
If your system interacts with customers and suppliers (or one or the other), verification takes place after the system is up and running. You say if a transaction is not completed an e-mail (or other notification) is generated - that should be part of the verification, I would assume.

This is from someone who has not been involved in software for almost 12 years so I can't speak to the current state of the art in software validation. Sorry I can't help more. I do hope someone else has some experience with this - I'd like to know what is done as well.
 
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