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Subject: RE: Extend Enterprise Business Documents toward Pharma?


Hi Joel,

 

I received this as a member of the Pharma group and thought it might help to fill you in on the current work going on in the BusDocs group.

 

We are focused on two broad areas:

 

·         Business Document Structural Model

 

o   Aggregated authoring of topics is the first issue here. We are working on requirements and recommendations to support interoperability between:

§  An “aggregated document” which combines all topics together for editing, and

§  Individual storage and editing of the topics that comprise the aggregated document and a DITA map that represents the aggregated document.

o   Other very broad structural requirements of business documents that we are examining include:

§  How the DITA <topic> relates to a business document component and how DITA’s nesting of topics is best implemented for component flow, storage, and reuse

§  The ability to see/manipulate table of contents/table of figures/table of tables while authoring

§  The ability to apply specific numbering to headings and lists while authoring

§  Recommendation for handling multiple rows of repeating table headers

§  Recommendation for handling multiple note types: footnotes/endnotes/table notes

§  Etc., etc.

Based on our research, these are broad issues that relate to business documents across most industries. Our goal is to work through these types of requirements in the hopes that the DITA Technical Committee can provide “universal” business document recommendations. This will remove the need for each industry subcommittee to invest duplicate efforts and it will establish a more interoperable business document structural model.

 

·         Business Document Semantic Metamodel

 

As you saw in the presentation, the other area of the subcommittee’s work addresses the semantic metamodel. Some of our members are very focused on information modeling, and brought this experience to the subcommittee.  I think DITA is the best XML standard to combine ease-of-use for the author with an architecture that can support an enterprise information model, and appreciate the experience these members have in defining information types. They are currently working on the abstract model represented in the presentation. When that model is sufficiently vetted, the next activity would be to understand options for the technical implementation of the model within DITA.

 

Ultimately, it may not be possible for our subcommittee to come up with an semantic model that can be adopted as broadly as a structural model can be. The semantic model may be too general for some organizations, and too specific for others—that is the nature of information modeling. Regardless, is should provide waypoints for organizations who want to do similar modeling, and guidance from the Technical Committee on how to implement information models with DITA.

 

I hope this information is helpful and would appreciate understanding how you and others on the Pharma subcommittee view any synergies between our work.

 

Regards,

 

Michael

 

Michael Boses
Director, XML Products

Quark Inc.
970 Lake Carillon Dr. Suite 310
St. Petersburg, FL 33716
Phone: 727.235.6803

mboses@quark.com

Co-Chair OASIS DITA for Enterprise Business Documents Subcommittee

http://wiki.oasis-open.org/dita/BusDocs

 

 

 

 

 

 

 

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

http://www.imagesolutions.com/Portals/0/images/emailsig/isilogo.gif

 

Image Solutions, Inc.

100 South Jefferson Road

Whippany, NJ 07981

T: 847.989.6028

joel.finkle@imagesolutions.com

 


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