Gimermed Co. ltd was looking for a document management system (DMS) to help them classify, manage, and control their design history files, device master records, and other quality documents related to medical device development. Their existing process of just saving files was not compliant. OpenKM met their requirements for classification, version control, workflow/review capabilities, and an engineering drawing database. They chose OpenKM over larger PLM systems because it was easier to use and maintain and gave them more control over documents. After testing the trial version, they implemented OpenKM to help manage documents according to their taxonomy and meet ISO quality requirements.

1. Gimermed Co. ltd
Case study : OpenKM system solve
our problem

2. Our problem
device history records
Design history File
Device Master Record
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.

3. Our require DMS
Design history File
Device Master Record
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
We try to find the
5. Auto record meeting progress
6. Finally, we can easy to read and document system to
manage our document
find Document
device history records

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

5. Trial version demonstrate
So now we use trail version to
control and manage document files.

6. 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.

7. 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.

8. Conclusion
Manage
Notify
Control
Easy to Document control and
met the ISO requirement.

9. Thanks you!