case study: gimermed ltd
DESCRIPTION
How OpenKM system solve our problem. 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.TRANSCRIPT
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!