GAMP 5 - Categories for Software Solutions

COMPUTER SYSTEM VALIDATION (CSV)
1

Hi,

Can someone please clarify under which GAMP category would the COTS applications fall under?

My query is pertaining to the EDC, CTMS, IVRS and other eclinical software solutions.
All these solutions generally have in-built codelists and library pool which cannot be modified but can be configured as per business requirements.

Similarly, there could be additional template configurations which can be modified and used for generating reports.

So will these applications fall under GAMP Category - 3 or will they come under Category - 4 ?

Thanks,
Vinoth

2

Hi everyone,

I had my question answered on Linkedin.

You can follow it using the below link:

http://www.linkedin.com/groupItem?view=&gid=2029382&type=member&item=207310186&qid=e7468c30-dabb-4479-9a17-e6af21f793eb&trk=group_most_recent_rich-0-b-ttl&goback=.gmr_2029382

3

Hi Vinrox,

Without knowing your application in full detail, from what you are explaining its a COTS 4.

MS Word, MS Excel etc would fall under Cat 3.

Regards

4

As you can see I have mentioned them in my question description.

I am specifically referring to EDC, CTMS, IVRS and other e-clinical solutions which are used by various clinical research and pharma organizations.
Generally these enterprise applications, have codelists and templates which can be configured as per business user needs, without actually changing the
code.

In this context, I was looking for an answer.

5

You are actually answering your own question if they are configurable then they fall under Cat 4.

Please go to ISPE and purchase GAMP 5 for more explanations.

Regards

6

Hi Gokeefe,

I had a confusion over the category - 3 and category - 4 before I had posted over here this morning.
So I had actually assumed that these COTS applications were similar to the standard software packages just like MS Excel or Word.

But small customizations and configuration changes are possible in MS Excel and MS word right.
For eg: You can change your default ‘save options’, ‘Fonts’ etc.
And these applications like you mentioned fall under category - 3, yeah?

In that context I had assumed that even COTS application with minor configuration changes can fall under category - 3.

But after a couple of readings of GAMP on the internet, I found that my assumption was conflicting to the GAMP context.
It said that I should be considering them under category - 4.

So that’s where the confusion was.

And now after further reading and from the replies from my Linkedin friends, I got my doubts clarified.
Cheers !

7

Great to hear,

Remember also if you MS Excel with Marcos etc then they would need an increased level of validation more like Cat 4