Learnaboutgmp Community

Customized vs Configured

We’re working with a LIMS application right now, and the vendor has a
tool which allows the client to ‘configure’ the application thru a
gui. by ‘configure,’ the tool is actually allowing us to add database
tables, database fields in addition to writing custom code…all we see
in the front end is the new feature (but it really it may be a new
database table in the backend).

some people here are insisting that because the vendor intends you to
change the system, and they provide a tool to do it,
it’s ‘configuration.’ i’d argue that if you: 1. add/remove/modify
database tables 2. add/remove/modify database fileds or 3.
create/modify code, that this is all customization, regardless of how
easy or seamless it was to do it.

what have your experiences been?

also, other than obvious testing implications for customized
functionality, is there a regulatory implication as well? in other
words, would any of you be comfortable telling an inspector that adding
new database tables to an application is configuration?

The vendor has provided you with a tool to accomplish the task. As such, the vendor bears the responsibility for quality of the tool. Much the same way that Microsoft owns the wizards that you use for excel spreadsheets,
powerpoint presentation, word documents, and access databases and is responsible for their function. Microsoft is, however, not responsible for the products content, you are.
So, while what happens on the back-end is of concern to you, the mechanism used to perform it should be of less concern. In other words, you should focus on the product you created using the tool, which is the configuration, and not the process used to create it, which is the functioning of tool the vendor has created.
The rationale behind this approach is that there is a shared responsibility between you and the vendor for the overall quality of a configured product. Whereas, for custom code, the vendor bears no responsibility for the quality of the product, which is the code. This is the rationale used as the basis for the
GAMP 4 categories 4 (configured) & 5 (bespoke).