Medical Devices - Electronic DHF using Windchill?

[MikeLockwood]

We areplanning toimprove our DHF document management and reporting approach - from being primarily paper-based to being all-electronic, using Windchill. We're currently exploring a variety of approaches within Windchill.

Areyou currently doing this in any way or planning to do so? Care to share info, notes, experiences?

thank you

[rmp.pe]

Mike,

We're using the MDT DHF function in 9.1 for a small number of our products. It uses document structures to create a DHF document and ties it to an end item. From the end item you can generate a DHF report with clickable links to signed versions of documents and other information, including the end item BOM.

There are a few drawbacks with this approach:

• You have to baseline your DHFs in order to see what version of documents were in it when you release a product or at any other point in time. Document Structures are version independent, and if you don't do this, you will always see the latest version of the child docs and won't be able to see any snapshots
• There is no "grouping" mechanism. For example, you might want to have a "Feasibility" section, a "Verification" section and a "Validation" section of the DHF (typically we have done this in our paper DHF binders). The only way to do that would be to create dummydocuments for grouping purposesso that you could have two levels of document structure. Otherwise it just appears as one huge list of documents.
• You should look into how to set up the DHF/End Item relatioship so that the end item cannot be released until the DHF is released. You should look into the same type of rules for not releasing the top-level DHF unless all child documents are also released. Nobody needs a released DHF with content that is still in work...

Regards,

Bob