Case study: Gimermed ltd

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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.

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Case study: Gimermed ltd

  1. 1. Gimermed Co. ltd Case study : OpenKM system solve our problem
  2. 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. 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. 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. 5. Trial version demonstrate So now we use trail version to control and manage document files.
  6. 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. 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. 8. Conclusion Manage Notify Control Easy to Document control and met the ISO requirement.
  9. 9. Thanks you!

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