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Subject: RE: Extend Enterprise Business Documents toward Pharma?


I have been very aware of this working group for years, and have been speaking to the co-chairs, Ann Rockley and Mike Boses about cross-pollination of efforts.  Mike is actually on the PC-SC as well.

 

 

-        Gabor

 

From: Joel Finkle [mailto:Joel.Finkle@imagesolutions.com]
Sent: Tuesday, October 12, 2010 10:46 AM
To: dita-pharma@lists.oasis-open.org
Cc: MBrenna3@its.jnj.com; Laura.Zupko@gsk.com; Martin.Sjoholm@astrazeneca.com; David.H.Brown@astrazeneca.com; thomas.brunner@novartis.com; janet.stoltenborg@astrazeneca.com; peter_civitarese@merck.com; Monica.Mehta@genzyme.com; Brooke.Hinkson@genzyme.com; averbacj@ls-integration-partners.com
Subject: [dita-pharma] Extend Enterprise Business Documents toward Pharma?

 

I just stumbled upon another DITA subcommittee's documentation, that of Enterprise Business Documents.  There's a great presentation at

http://www.oasis-open.org/committees/download.php/36620/Business%20Content%20Metamodel-1.pptx

 

The document types they're working on are certainly different from regulatory submission documents, for the most part, but I can see that a company that already has its HR documents, policies and procedures, etc. built on this should be able to start extending into regulatory documentation.

 

This may help us frame the kinds of extensions to the DITA model that we will need for things such as protocols, reports, etc.

On the other hand, this may steer us into thinking in terms of extension to their data types (Event and Governance, for instance, sound useful) but might be dead ends in terms of creating our kinds of documents. At its worst, companies might say that you can't build a DITA-based protocol without having DITA-based SOPs, DITA-based Policies, etc. etc. which could slow down acceptance.

 

In any case, it's worth a read.

 

Joel

----

Joel Finkle

Director, Regulatory Informatics

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Image Solutions, Inc.

100 South Jefferson Road

Whippany, NJ 07981

T: 847.989.6028

joel.finkle@imagesolutions.com

 


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