Validation of new ERP system

blackholequasar

The Cheerful Diabetic
#1
Hello, all!

My facility is switching over to a new ERP system. (Background: We build PCBs, cables and boxes to customer prints, we are certified to ISO 9001, have less than 50 employees and it is a mostly family-run business) The old ERP was so antiquated that we have to run it on a server that has WindowsXP installed. Needless to say, this is a welcomed change however when I mention doing a validation for the new ERP (Dynamics 365) I am met with a lot of resistance. To me, this is a critical process we are changing and there is a lot of really critical data being transferred. I wrote a quality plan for installation but there is no firm date for implementation, all I hear is "by the end of the year".

We are not compliant to 21 CFR or ISO 13485, but the CEO wants to seek it within the next 2 years. I tried to impress how important it is that our key processes (such as ordering, quoting, processing customer orders, etc.) should really be treated with a higher sense of risk but... I don't know, feeling defeated and wondering if anyone has anything to offer that I could present to him regarding how critical this process is? The whole company uses the ERP to function. Why would we not have plans in place for implementation, risk, validation (IQ/OQ at least) and training...? I appreciate everyone's insight! Maybe I'm just being wound a little too tight haha
 
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William55401

Quite Involved in Discussions
#2
As a quality professional, your thinking may begin with current / future statutory and regulatory requirements that tell WHY something like software validation must be done. As a business partner to the GM / CEO, your messaging has to be on WHY the validation (and all the associated fun) is important to overall business success. What is the financial impact of implementation issues with the new ERP system? Messaging on regulatory compliance, while one element to ERP success, can be a turn off to the business leaders. Messaging matters. Be polite. Be persistent. Talk in their language (time, money, customer impact). Have fun; enjoy the ride.
 
Last edited:

Ed Panek

QA RA Small Med Dev Company
Leader
Super Moderator
#3
Another message I find powerful is the "high barrier to entry" message. Doing this work takes time and money... time and money our competitors may not have. Our doing this, aside from meeting requirements, is hard and costly to do. It makes competing with us more challenging and is a business value add.
 

BradM

Leader
Admin
#4
Hello there!

In addition to any customer/ regulatory requirement, minimally management would seem to be interested in whether the system will do what it intends to do. I'm not an ERP expert. But I do know they are quite involved in the implementation, and many times there are clear objectives, processes, and deliverables identified. So the consultants/implementation folks, just kind of do what they feel is best. That is many times not at all what management was envisioning when they funded the project.

So hopefully there is something done, to assure the system has the desired inputs/ outputs, and any desired process actions are identified correctly.
 
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