Building XML Projects for an
  FDA-Approved Device:
          3 Approaches
    and Their Success Factors
      Dorothy J. ...
A Quick Tour of Terminology
• DTD or schema: the rules for organizing and
  defining/naming XML elements and attributes
• ...
Are We Saving Money Yet?
   A Cautionary Tale of 3 Projects
• A global company manufacturing complex
  medical equipment (...
Impact of Complexity
• Customization increases complexity
                                                            Cust...
3 Projects: Overview
Project       # docs       #      Output types       Custom or     Other
              (English)    l...
Large-Scale Project
             Documents
 Writers
             on server Email for      DOC   Print for         Hard
 us...
Large-Scale Project
Writers use
                              Controlled authoring, editing and
XML editor
               ...
Large-Scale Project

                        Generate      PDF PDF                 PDF
Review and              PDF, email ...
Large-Scale Project
• XML routed for translation, In Country
  Review (ICR) as PDF, returned with CTA
• One doc per workfl...
Large-Scale Project
                                       CD, print, web distribution
                                   ...
Large-Scale Project
• Changes to the original DTD meant expensive
  ripple effects for PDF and conversion.
• The workflows...
Large-Scale Project
• Summing it up: High complexity, complete
  custom solution, high cost proprietary
  system, few user...
Medium-Scale Project
• Meanwhile, another project: software
  troubleshooting messages. Over 2 million words
  of highly r...
Medium-Scale Project
• Legacy: Troubleshooting content was
  previously in HTML
  – not consistently in either wording or ...
Medium-Scale Project
• Developer based DTD on HTML plus a
  small set of custom elements.
• Developer worked out entire pr...
Medium-Scale Project
 Vars   ->    Chunks   ->   Collections

               A   B   C        A    B    C   A   C
   A    ...
Medium-Scale Project
• CMS provided version control, “where used”
  reporting, integration with authoring tool during
  ch...
Medium-Scale Project
• Reuse made translations very consistent.
• As more content was translated, got more
  benefit from ...
Medium-Scale Project
• After translation, the XML was batch-converted
  with open-source tools to the final HTML and .txt
...
Medium-Scale Project
• In Summary: Highly successful project, on time,
  creating huge savings, due to simple DTD and
  ex...
Small-Scale project
• Customer needed reference documents
  and Help files on equipment, about 650
  topics x 17 language ...
Small-Scale project
• Writers already familiar with other XML,
  got some DITA training.
• Open source tools made it easie...
Small-Scale project

               XML


          CMS archives
          documents of
          record TMs


• SaaS mode...
Small-Scale project
• Contract is for user licenses and hosting,
  not for software application licenses.
• All content ca...
Small-Scale project
• Set up and initial content import plus
  training included for $40K. Additional work
  pushed costs ...
Small-Scale project
• Numerous delays due to small SaaS staff.
• SaaS’ built-in XML editor was not very
  robust or sophis...
Small-Scale project
• Emergency solution -- exported the XML
  from the SaaS and used XSL to “resolve”
  the referenced te...
Small-Scale project
• Leveraged processes developed for the
  medium-scale project to develop
  processes for the small-sc...
Small-Scale project
• Vendors create translation memory files of
  resolved XML offline.
• Import the TMs back into SaaS, ...
Small-Scale project
• Summing up: SaaS much less expensive
  than enterprise CMS plus XML software
• Some problems directl...
3 XML projects: Conclusions
• Flexibility of XML is proven (again) –
  can engineer various solutions to meet
  customer n...
Dorothy’s Top Rules for XML
          Project Success
• Think of an XML project more like software
  development than cont...
How to Save $$$$$$$$
• Make sure there are sound business reasons for
  XML that management supports. Translation +
  reus...
Success Factors: More is More
• Volume: #docs x #langs x #outputs
• Reuse: among same docs, across doc
  sets, TM, output ...
Questions?
• Dorothy Hoskins can be reached at
  dorothy.hoskins@novatekcom.com or
  585.482.4070
• Novatek Communications...
Building XML Projects for an FDA-Approved Device: 3 ...
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Building XML Projects for an FDA-Approved Device: 3 ...

  1. 1. Building XML Projects for an FDA-Approved Device: 3 Approaches and Their Success Factors Dorothy J. Hoskins Novatek Communications, Inc.
  2. 2. A Quick Tour of Terminology • DTD or schema: the rules for organizing and defining/naming XML elements and attributes • CMS: content management system. • TM: translation memory, a file that can be used to find identical, similar or related words among translated documents • Workflow: a method to route documents and messages from one worker to another
  3. 3. Are We Saving Money Yet? A Cautionary Tale of 3 Projects • A global company manufacturing complex medical equipment (FDA regulated) has been heavily invested in XML technology for documentation for over 3 years. In 3 projects, they may have lost a lot of money overall – or have they saved millions? • It’s a story of XML design, infrastructure, and content control from writing to approval to translation to customer use
  4. 4. Impact of Complexity • Customization increases complexity Custom DTD, 250 elements, Complexity (# elements Custom PDF + HTML + RTF and customization) DTD, 50 elements, text + HTML Standard DTD, 50 elements, HTML Increase in cost to deliver outputs
  5. 5. 3 Projects: Overview Project # docs # Output types Custom or Other (English) lang standard Large scale Thousands 11 PDF on Custom Regulated CMS, (hundreds then CD/web, RTF (complex audited integrated x multiple 18 (user-editable), DTD of 250 content XML editor versions) and HTML elements) (FDA (later if ever) approved) Medium thousands 18 HTML with Custom Embedded size, open cross-linked (simple DTD in device; source navigation plus of 50 product- tools plain text, PDF elements) specific for internal use Small scale hundreds 18 HTML with Standard Embedded DITA plus cross-linked (50 elements in device SaaS navigation, subset of PDF on CD DITA)
  6. 6. Large-Scale Project Documents Writers on server Email for DOC Print for Hard use copy review approval approved DOC Ink date/sig Word Track Word template changes Paper files • Legacy of Word documents, “wet” signatures, paper file storage of versions • Translated the approved Word files, got Certificate of Translation Accuracy (CTA)
  7. 7. Large-Scale Project Writers use Controlled authoring, editing and XML editor XML versioning of FDA-audited content approved WYSIWYG template CMS archives documents of Revisions record + sigs • Complex XML DTD requires complex WYSIWYG template in XML authoring tool • Version control provided by CMS check out/in integrated with the authoring tool
  8. 8. Large-Scale Project Generate PDF PDF PDF Review and PDF, email approval approval XML for review workflow Track comments E -signature CMS archives documents of Revisions record + sigs • Custom transformation of XML (XSL-FO) to PDF for review & approval • E-mail alerts for tasks to workflow recipients • E-signature provided as part of CMS workflow
  9. 9. Large-Scale Project • XML routed for translation, In Country Review (ICR) as PDF, returned with CTA • One doc per workflow, multiple langs Translation workflow CMS archives XML Translation documents of vendors record + sigs Translation order x lang + English master Revisions TMs XML CTA CTA ICR x lang Approved Translations PDF (XSL-FO) XML PDF
  10. 10. Large-Scale Project CD, print, web distribution to end user (customer) XML RTF Send Generate Binders outputs CMS archives outputs to distrib. documents of x lang process record + sigs PDF • Control maintained in CMS up to distribution process
  11. 11. Large-Scale Project • Changes to the original DTD meant expensive ripple effects for PDF and conversion. • The workflows for review and approval, and translation workflow, were hard to set up and had unintended consequences. – Risks for changes very high – Documents in workflows are checked out, not editable • RTF output was buggy and required manual edits, not “single source” any more (synch XML and RTF changes for every revision).
  12. 12. Large-Scale Project • Summing it up: High complexity, complete custom solution, high cost proprietary system, few users, not as many documents as proposed. • Hard to recoup costs. • Was it worth it? Costs are not dropping over time, relative to the benefits. “Buyer’s remorse” setting in.
  13. 13. Medium-Scale Project • Meanwhile, another project: software troubleshooting messages. Over 2 million words of highly repetitive content. • Required integration as text and HTML files with software on the equipment. • Needed to add a lot of content and languages but the same time (or less) as last product development cycle.
  14. 14. Medium-Scale Project • Legacy: Troubleshooting content was previously in HTML – not consistently in either wording or HTML markup. – translated as HTML, but translators messed up HTML markup. • Needed: version-control and reuse (a lot of text was redundant).
  15. 15. Medium-Scale Project • Developer based DTD on HTML plus a small set of custom elements. • Developer worked out entire process end to end, proved and documented it. • Risks: custom code, multi-step process • Benefits: open source tools, batch outputs (lightning-fast)
  16. 16. Medium-Scale Project Vars -> Chunks -> Collections A B C A B C A C A B C D A B A B A B A C C B A C B A • Extreme A D reuse! A B A D A B • Mix-and- A C D C A C match at A D C A D C D C 3 levels C B A A D C
  17. 17. Medium-Scale Project • CMS provided version control, “where used” reporting, integration with authoring tool during chunk editing. • Open-source tools provide fast batch processing for outputs outside CMS. • Once chunks were approved in English, open- source tools used create XML English “translation masters” so the translators could see the complete text.
  18. 18. Medium-Scale Project • Reuse made translations very consistent. • As more content was translated, got more benefit from reuse in TMs. • Cost per word dropped to below .09/word, versus over .22/word in the translation estimate, saving about $1.7 million.
  19. 19. Medium-Scale Project • After translation, the XML was batch-converted with open-source tools to the final HTML and .txt files in all languages, by product configuration. • The folder structure of the HTML output was automatically generated so the links, images and the look and feel would be correct on the equipment.
  20. 20. Medium-Scale Project • In Summary: Highly successful project, on time, creating huge savings, due to simple DTD and extreme reuse of content. • Open source batch tools combined with CMS provided best of each system. • XML is now “content of record”, so can check out, edit, make PDF for approval process, and leverage existing translation.
  21. 21. Small-Scale project • Customer needed reference documents and Help files on equipment, about 650 topics x 17 language translations. • Wanted to use DITA to avoid costs of custom DTD, benefit from collaboration and Open Toolkit.
  22. 22. Small-Scale project • Writers already familiar with other XML, got some DITA training. • Open source tools made it easier to publish DITA “maps”. • Lacked version control system. • Found Software As A Service product which bundled XML editor, CMS, workflows and translation interface.
  23. 23. Small-Scale project XML CMS archives documents of record TMs • SaaS model provides application via web browser, users work “in the cloud”. • Global, 24/7 CMS access, XML content development and SaaS team support.
  24. 24. Small-Scale project • Contract is for user licenses and hosting, not for software application licenses. • All content can be extracted from the servers as backup in standard XML. • Customer owns the translation memory, which resides on their server.
  25. 25. Small-Scale project • Set up and initial content import plus training included for $40K. Additional work pushed costs up >3x. • Migrating existing DITA required change from standard DITA to CMS schema.
  26. 26. Small-Scale project • Numerous delays due to small SaaS staff. • SaaS’ built-in XML editor was not very robust or sophisiticated. • Sometimes the server’s downtime lost work and created delays. • Translation vendors complained that the TM segment interface slowed them down, estimated 3x the time to translate.
  27. 27. Small-Scale project • Emergency solution -- exported the XML from the SaaS and used XSL to “resolve” the referenced text. • Developing offline processes added some complexity and costs to the project. – regression testing of XML in CMS. – testing output processes that translation vendors would use.
  28. 28. Small-Scale project • Leveraged processes developed for the medium-scale project to develop processes for the small-scale project in a few weeks. Same concept of open-source batch processes for merging XML fo create translation masters, producing the HTML for ICR.
  29. 29. Small-Scale project • Vendors create translation memory files of resolved XML offline. • Import the TMs back into SaaS, then can review in segment view. • Translated, approved content used to generate PDF and HTML from SaaS’ CMS as originally intended.
  30. 30. Small-Scale project • Summing up: SaaS much less expensive than enterprise CMS plus XML software • Some problems directly related to SaaS model or SaaS company. • Could be an important tool for global content development when mature.
  31. 31. 3 XML projects: Conclusions • Flexibility of XML is proven (again) – can engineer various solutions to meet customer needs as they arise. • Speed, accuracy and efficiency gains from translation are very significant. • Project must be well-designed to achieve hoped-for results. QA needed for every process/output.
  32. 32. Dorothy’s Top Rules for XML Project Success • Think of an XML project more like software development than content development. • Keep it simple. • Pilot the entire project through every stage possible. • Allow 3x the time and money that the vendor initially estimates. • Involve your writers, SMEs and translation vendors from the start in selecting applications. • Make QA part of every process for initial development and every time system changes.
  33. 33. How to Save $$$$$$$$ • Make sure there are sound business reasons for XML that management supports. Translation + reuse + infrastructure + experience = succe$$. • Perform risk analysis as well as cost/benefit analysis for all parts of the XML project. • Work with experienced developers. • Work backwards from the deliverables to the content model. • Determine workflows for review/approval and train SMEs in your XML system.
  34. 34. Success Factors: More is More • Volume: #docs x #langs x #outputs • Reuse: among same docs, across doc sets, TM, output formats • Time: 6 mo. pilot, up to 1.5 years prior to launch; not tied to quarterly budget; milestone deliverables • Funds: for infrastructure, training, development, implementation, QA • Leadership: long-term planning
  35. 35. Questions? • Dorothy Hoskins can be reached at dorothy.hoskins@novatekcom.com or 585.482.4070 • Novatek Communications, Inc., provides technical documentation, eLearning/LMS and XML services. Novatek Communications, Inc. 500 Helendale Road, Suite 280, Rochester, NY 14609-3173 (Tel.) 585.482.4070 (Fax) 585.482.4098
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