Gimermed Co. ltd

Case study : OpenKM system solve our problem

Our problem

Device Master Record

Design history File

device history records

When develop Medical device (MANZU PNS) ,we follow GMP guideline writing relevant documents(DMR、DHR、DHF) ,but not comply to the Quality document control requirements. That just like up schematic diagram. We generate file but haven't system to do document classification and manage.

Our require DMS

Device Master Record

Design history File

device history records

1. We want the system can easy to classify document files and connect relevant files.

2. Version control. 3. Workflow(review &comment

record ) 4. Engineering Drawing database 5. Auto record meeting progress 6. Finally, we can easy to read and

find Document

We try to find the document system to

manage our document

Why we choice OpenKM

1.It’s PLM system ,too big we can't maintain system operate and not easy use. 2.we not easy control document on it just use few step to complete in this system.

OpenKM met our require, 1.easy use and manage 2. version control 3.convenient to notify everyone document change

Trial version demonstrate

So now we use trail version to

control and manage document files.

We use Taxonomy Interface to manage our company administrative document. And this very easy control document version

and user can easy to check out and check in and notify ,and easy to view what the files content.

We use Categories interface to control our DMR,DHR.DHF and this function can let us manage the files and see every medical device every Phase connection.

Conclusion

Manage

Control Notify

Easy to Document control and met the ISO requirement.

Thanks you!