GAMP CAT 5 Change Control

diogo19

Starting to get Involved
#1
Hi,

I have a custom built ERP that requires a minor admin change to text heading,
This system is validated as GAMP CAT 5,
I've created a change control for the proposed change and modification but the change control doesn't have a risk assessment,

Can this change proceed without the system/software version number updating ?


Thanks
 
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lanley liao

Involved In Discussions
#2
Hi, Diogo,
You don`t need to do this change, because this is a general adjustment for the ERP software function. Therefore, My suggestion is that the ability of ERP software to satisfy the intended application shall be confirmed prior to initial use and reconfirmed as necessary.
 

diogo19

Starting to get Involved
#3
Hi, Diogo,
You don`t need to do this change, because this is a general adjustment for the ERP software function. Therefore, My suggestion is that the ability of ERP software to satisfy the intended application shall be confirmed prior to initial use and reconfirmed as necessary.
Hi,

Thanks for the reply,

Just to confirm, the ERP software has been in use for many years,
Usually, major changes or a collection of changes (e.g minor) would be captured in a new validation which updates the software version number,

How can I justify that is a 'general adjustment' without it affecting the intended use of the system ?
I thought for CAT 5 systems anything that's modified would need to be processed through change control.
 

yodon

Staff member
Super Moderator
#4
First, let me work over this statement:
major changes or a collection of changes (e.g minor) would be captured in a new validation which updates the software version number,
All changes should be managed through some kind of change record (with risk assessment - which you indicated in the original post). The version number changes after one or more changes are implemented and the system is released. Validation confirms the system is still working after the changes.

I'm curious why a system that has been in use for many years now requires a change to the text heading? Why can't this wait until other changes are implemented?

And why can't you do a risk analysis on the change? Sounds like it should be pretty low risk!

I wouldn't release any change without some change to the version identifier. Most systems have a 2 or 3-tiered release identifier; e.g., "<major>.<minor>" or "<major>.<minor>.<patch>". If it's absolutely necessary to release this minor administrative change now, I would at least do something like "x.1" (where 'x' is your current version). You just never know. You could be using a new compiler version that compiles unchanged code differently, you could be pulling in changed runtime libraries when you build that could drive a different behavior, etc.
 

diogo19

Starting to get Involved
#5
Hi Yodon,

Thanks for the reply,

I should have been more clearer,

The change is to template wording that is stored in the ERP and no code changes are modified that would have impact,
Would I still need to update the version identifier because of this ?

The change control I work with is very basic and needs the introduction of a risk analysis.
 

yodon

Staff member
Super Moderator
#6
Apologies, but I'm still not completely clear on what exactly is changing. Do you have to rebuild (compile) the software? If so then I suggest the version number be incremented. If this change is to a form that you store in the ERP system then I would think you would change the version of the form.
 

lanley liao

Involved In Discussions
#7
In fact, it is just a general change. because you only will modify its text heading. You should be processed by change control as per the CAT 5 system, and remain related change records would be ok.
 

diogo19

Starting to get Involved
#8
Apologies, but I'm still not completely clear on what exactly is changing. Do you have to rebuild (compile) the software? If so then I suggest the version number be incremented. If this change is to a form that you store in the ERP system then I would think you would change the version of the form.
Hi, so I just found out the change is to the HTML of a pdf form stored in the ERP, no rebuilding of code was impacted, in your opinion would that warrant a version number increment ? or would you simply risk assess in the change control and specify it has no impact ?
 

diogo19

Starting to get Involved
#9
In fact, it is just a general change. because you only will modify its text heading. You should be processed by change control as per the CAT 5 system, and remain related change records would be ok.
Thanks, what are your thoughts on updating HTML in the template , is that considered a general change ?
 

yodon

Staff member
Super Moderator
#10
Ideally, you have some version info on the form but in general, no, I don't believe this would not drive a revision update to the system.
 
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