Switching (Migrating) to a new QMS Software Package

Morlock

Starting to get Involved
#1
Hey all!

So, our current QMS software is being phased out by the provider, and we have identified and vetted (through free sandbox trials) a new QMS. This will be my first time being involved in something like this, and as a QA Manager, I will be very involved, so naturally I have some questions before I get elbows-deep.

Does anybody have any tips or tricks for switching from one QMS software to another to minimize the impact and to help make this transition as quick and painless as possible? Is there anything we should be looking at concurrently while we're doing this? For instance, are we able to cull obsolete PNs, documents, etc. at this time, or do we need to migrate those over, too? Is it better to revise the documents to reflect the new QMS software before or after migration?

We're ISO 13485, if that helps. To clarify, we're not looking to make any significant changes to any of our QMS processes, or content changes to any documents (outside of the obvious "how to create a document in [insert QMS platform here]" type documents), we're just migrating to a new QMS hosting platform.

Oh, and a curveball, Our current QMS and the new QMS cannot operate on the same OS, so we're looking at a very-literal "flipping-the-switch" thing, where we have to take one system offline before we bring the other system online. Although the IT guy might have a workaround for this...

Thanks all!
 
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AndyN

A problem shared...
Staff member
Super Moderator
#2
Firstly, is this change documented in your management review? Secondly, do you have a plan? Clear responsibilities? Time line? Testing and expected results? Have you considered the consequences of the migration not going to plan? Plan "B"?
 

Morlock

Starting to get Involved
#3
Firstly, is this change documented in your management review? Secondly, do you have a plan? Clear responsibilities? Time line? Testing and expected results? Have you considered the consequences of the migration not going to plan? Plan "B"?
Thanks for the quick reply! We (management) just decided today to pull the trigger and place the order for the new QMS software, so what was on kind of a low simmer in the background now got moved to the main burner, but we're still in the pretty early phases. 1st step was to find a QMS software package we liked that checked the boxes for us. That's about as far as we've gotten at the moment...

-The migration is on the MR Agenda (happening later this week), but we're a small company, and management is already well aware of the situation, and is updated frequently;​
-I have started putting together a plan for a plan, but any advice regarding specifics would be appreciated;​
-Most of the responsibilities lie with me and the IT guy at the moment, but clearly defining and assigning them would be a great tool for the project;​
-Our time line at the moment is simply a window between once we get the new QMS software online, and when our licensure for the old QMS software expires;​
-From what we tested via the trials, all of the structure is there in the new QMS platform. It'll just be a matter of importing/inputting employee names into the "employees" section, equipment into the "equipment" section, gauges into the "gauges" section, assigning PM and cal. dates, uploading docs, etc;​
-Plan B at the moment is to continue with the old QMS software, without support for it (it's locally hosted).​
 
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yodon

Staff member
Super Moderator
#4
You're probably in for a thrilling adventure! :)

I would probably advise against your Plan B. At some point, something will occur (OS upgrades, backend database engine upgrades, etc.) that will likely prevent the system from working.

I would, though, probably plan on keeping it online for access to what's in there. Even if you migrate things to the new system, it's almost certain that historical information and relevant metadata (e.g., data related to e-signature manifestation) will not be migrated.

As the old system (as well as the new system) represents software used in implementing the QMS, it should have been validated. You should validate the new system prior to going full online.

If you are migrating information (and I presume you'd pretty much have to), you'll want to validate the migration as well.

You likely have things in process in the old system so you'll need to plan on what to do with those (cancel / start over on the new system, push through to completion on the old system, etc.).
 

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