Handling DITA Topics and Translation in a Regulated Industry

…soon to be known as CaridianBCT, Inc.

Globalization and English Management Planning for the Future

Agenda

• Background Information• Case Study – Problem Statement• The Solution• Preparing for the New Environment• Concerns, Benefits, and Lessons Learned

About CaridianBCT, Inc.

• Medical device manufacturing company• Specializes in the design of blood component

technology• Global Headquarters – Colorado, USA• European Headquarters – Brussels, Belgium• APAC Headquarters – Hong Kong, China

Technical Communications Responsibilities

• Authoring and translation of • all labels for BCT equipment: Operator’s Manuals,

Instructions for Use (IFUs), kit, case, and bag labels, Tyvek disposable kit covers

• service materials: service manuals, preventive maintenance procedures, schematics, installation procedures, spare parts instructions

• other technical documents as requested: training materials, protocols, Standard Operating Procedures (SOPs)

Regulatory Standards

USA• Governed by the FDA CFR Part 801 (Code of Federal

Regulations)

EMEA• MDD [Medical Device Directive (93/42/EEC)]

• Annex 1, Essential Requirements• II. Requirements regarding design and construction,

• Point 13. Information Supplied by the Manufacturer

Canada• Health Canada – Sections 21 and 23 of the Medical Devices

Regulations• CSA (Canadian Standards Association) – Electrical Standards

accepted in most countries

Regulatory Standards (cont.)

APAC• APAC uses IEC (International Electromechanical Commission) and

ISO (International Organization for Standardization) as a baseline for their own standards.

• This includes China and Japan.

Internal • SOP for BCT Labeling Approval and Control• MDD definitions for labeling are broad enough to be applied

generally to all BCT labeling.• Changes made on a country-by-country, region-by-region basis.

Case Study – Background Information

• As per the MDD, all labels written in source language (in our case, English) requires translation into the target languages in which the product is sold.

• Currently, CaridianBCT sells products in <20 countries worldwide.

• Structure, format, and approach to customer documentation can drive up costs for all English and translated deliverables.

• CaridianBCT is tasked with reducing translation costs and increasing consistency across deliverables and product lines.

Case Study – Problem Statement

• COBE Spectra® Apheresis System Manual• The English version of the manual is currently a 4-volume

set. • Some world areas are reluctant to translate the entire set due to

cost constraints. • Creating documents to meet requirements while remaining

“usable” is a challenge!• Each country has specific regulations that must be met in order

to sell within that country.

• Each country may interpret what you write differently.• It is the writer’s job to ensure the regulations are met, the

document is usable, concise, inexpensive to translate, and available for all countries.

• Creativity is limited

Case Study – Interim Regulatory Solution

• Created an “abridged” version of the manual to meet specific regulations for EMEA.

• APAC paid for translation of entire 4-volume set.• Abridged manual is not intended to be used as a training tool,

guideline for SOPs, or for a procedural manual for the equipment.

• Purpose - to provide a translated version of the manual in order to meet the basic regulatory and language requirements of the countries in which we intend to sell the product.

• Each product receives the translated abridged version, plus a full manual in English.

• Meets the regulatory requirements, while providing necessary information to the end user.

Bottom Line: There is still a problem - this creates two different source documents to manage, review, and translate

Case Study – Managing the Growth

• What are we going to do about the growing number of documents created that have the exact same content?• The number of labels increases each year, AND content must

remain consistent between all different deliverables.

• CaridianBCT needs to deliver both paper and electronic-based user material with the same content.

• Manual updates through FrameMaker causes inconsistencies with content.

• Application-based authoring systems are expensive to maintain, and translation costs over time increase exponentially.

• Retranslating the same content over and over can be costly and error prone!

The SolutionImplementing DITA XML, Content Management, and Translation Management

Globalization and English Management

Tools and Technologies

• DITA (topic-based) authoring• Improves reuse• Improves time-to-market• Improves consistency in deliverables

• Content Management System• Central storage location for all authors and departments to

access

• Translation Management System• Manages our translated content• Improves term consistency

Non-Regulated vs. Regulated Environments

Non-regulated• Output flexibility

• Allows for more dynamic deliverable creation and delivery options

• Quick roundtrip translations• No ICR (in-country review)

required

• Customer responsibility to retrieve needed information.

Regulated• Thorough output approval

• Every deliverable hierarchy and format must be reviewed.

• Engineering Change Orders (ECOs) required.

• PDF/Print needed vs. electronic delivery

• In-country review• Complicates integrated workflows

between CMS/TMS

• Proactive communication to customers• Not only are we regulated, our

customers are as well.• It is our responsibility to provide

thorough documentation of changes from version to version to the customers.

Bottom Line: There are more detailed considerations required to implement a topic-based authoring and translation environment in a regulated industry

Preparing for the New Environment

• Because we are in a highly regulated environment, we must make sure we have crossed all our t’s and dotted all our i’s – it’s better to think about it all before it sneaks up unexpectedly.• Identify all stakeholders

• Define personas

• Establish a high-level process

• Develop system requirements

• Create an information model and L10N style guide Document a CMS/TMS user guide

• Document business process and procedures

• Qualify LSPs (Language Service Providers) and establish an ICR (in-country review) process

Stakeholders

• Upper Management• Authors• Localization

• Localization PMs, LSPs, Translators, In-Country Reviewers

• Reviewers (SMEs)• Regulatory department

• Discussions with the regulatory department to establish an approval process for individual topics

Future Environment Persona Descriptions

• Identify the roles, responsibilities, and training plan for each of the internal people in the department• Writer/Content Contributor• Editor• Production Coordinator• Reviewer/Approver• Information Architect• Tools Super User• Project Manager• Localization PMs and Coordinators

CaridianBCT’s Tech Comm Future Process

• Plan/Design • Authors create project plan specification, master topic list, and initial shell

DITA Map (TOC) for review

• In Development • Authors create topics of content (tasks, concepts, references)• Authors initiate a workflow to send groups of topics for review

• Review/Validate• Reviewers open the task in the CMS Reviewer tool and adds comments

• Approve• Content approvers review and approve the content at the topic level to

freeze the topics before sending them for translation• The CMS records the comments and sends the information through the rest

of the workflow to be produced as a deliverable

CaridianBCT’s Tech Comm Future Process (cont.)

• Translate• Send groups of topics that have changed source content to translation

rather than sending the entire manual to translation again

• Assemble/Produce• Apply stylesheets to publish output (PDF, HTML, RTF, PDA/Mobile device)

• ECO (Engineering Change Order)• Content approvers review the document as a whole to approve the final

output. Much of the content approval is complete at this stage due to the previous approve stage. This is a regulatory step to approve the final output.

• Publish/Deliver• Send final output to the printer or web publishers group

CMS/TMS System Requirements

• Infrastructure• System Administration• Customization• Migration Support• DTD support• CMS Repository Functionality• Version Control• Workflow• DITA Topic Authoring

(Integration) • DITA Map Authoring/Creation• DITA Content References

• Metadata• Search• Editing/Review• Linking• Translation/Localization

support (CMS)• Production• Conditional Processing• Usability• Translation Memory /

Terminology Database

Create an Information Model/L10N Styleguide

• CaridianBCT’s information model• Information Type Definitions• Content Unit, Body Element, and Inline Element Type

Definitions • (Internally specific DITA Language Reference)

• Document Structure Element Definitions• (Internally specific DITA Map Definitions)

• Metadata Descriptions• Includes translation metadata (valid xml:lang attribute values)

• CMS/TMS Folder Structure Definitions• Naming Conventions Definitions

• Attribute values, DITA Topic file names, graphic file names, etc.

CMS/TMS User Guide

• CaridianBCT specific CMS procedures - documents internal business processes and workarounds when using the CMS• Adding a content reference (CMS)• Adding metadata in the CMS (CMS)• Checking in a topic (CMS)• Checking out a topic (CMS)• Creating a map (CMS)• Producing a deliverable (CMS)• Conditionally filtering a deliverable (CMS)• Reviewing topics (CMS/TMS)• Searching the CMS repository (CMS)• Sending topics to translation (CMS/TMS)• Creating an update during a translation project (CMS/TMS)• Creating a translation project (TMS)• Searching and editing the terminology database (TMS)• Searching the translation memory (TMS)

Business Process and Procedure Guides

• Documents the approach to working in a topic-based/CMS/TMS environment• Planning a DITA project

• Creating a master topic list• Creating a project plan specification for DITA projects (Creating your DITA

map shell TOC)

• Performing a QA on topics and deliverables (all languages)• Identifying stylesheet issues

• Identifying and applying conditional filtering criteria• Sending topics to SMEs for review

• Sending conditionally filtered information for review

• Approving topics for translation• Setting up DITA Maps for translation kits

• Sending updated topics to translation

• Updating the terminology database• Updating translation memory

LSP Qualification and ICRs

• Qualifying LSPs ensures they know our translation technology.

• Implementing an in-country review process promotes quality assurance.

• Ensuring regulatory standards are met in different countries by implementing in-country reviews.

• Changing requirements for LSPs• Be prepared that the current LSP base does not accept the new

environment and you may need to qualify/hire LSPs.

So where are we now?

GEM Environment – Future Concerns

• Existing LSP base may resist process changes• We found some of our LSPs did not like the improved internal management of

translated content on the client side.• LSPs did not like the drop in DTP, so charged more on PM.• LSPs may start charging flat fees for projects because we are eliminating the cost

of retranslating already translated content.

• ICRs performed at the topic level• In-country reviewers need to learn to review in a topic-based context.

• Stylesheets• We need to take an iterative approach to create our stylesheets to support multiple

languages.

• CMS and TMS configuration and functionality pitfalls• We need to anticipate enhancement requests for the tools before they cause

problems during live projects• The integration of the CMS with the TMS needs extensive testing• Using new tools is hard for everyone – authors, reviewers, translators, in-country

reviewers, etc. all need training (usually more than once)

GEM Environment – Known Benefits

• Translation cost savings of nearly $5,500/language/deliverable• Eliminated desktop publishing• Decreased translation costs because of TM leverage and

internally managing previously-translated content• PM costs reduce as well

• Reuse• Reuse content at the topic level by referencing the different topics

into hierarchical maps to create deliverables.

• Write once, Edit once, Review once, Translate once, Produce multiple times.

• Process efficiency is greatly improved.

GEM Environment – Known Benefits (cont.)

• Flexibility• Create different types of deliverables for different audiences,

locations, media (HTML vs. Print), and in many different languages

• Conditional filtering - authoring and translating nearly similar content and filtering only what is needed in-house to publish specific deliverables for specific product version or audiences.

• Portability• More than just technical documentation can use these technologies

–Marketing, Training, Web Development, and other departments can use this method for creating information and keeping it consistent throughout all deliverables.

Bottom Line: In the pilot project, CaridianBCT is producing 24 deliverables from one source and one translation project because of reuse and conditional filtering and saving nearly $100,000

What does it all mean…

…from a regulatory perspective?• Consistency!!!

• We no longer have to update multiple sources.

• Eliminate manual creation of change lists• We can now more easily create change lists for our regulated

customers using topic and map comparison on different versions.

• Expanded language base• Using these systems and technologies, we increase the number

of languages without drastically increasing the cost.• If we have the deliverables available in the target language, it

makes it easier to be able to sell the products in those countries.

Business Lessons Learned

• The transition from manual-based authoring to topic-based authoring is not just something to think about in the technical documentation department, it affects everyone in the company (reviewers, regulatory, translations, etc.)

• Know the regulations! They drive your documentation• Partner with the internal Regulatory department to understand how

regulations are interpreted at your company. The regulations and interpretation may vary depending on the organization.

• Understand the user base and their access to technology. The users may differ depending upon which product they are using.

• For example, nurses may not be able to use electronic manuals or help systems at the patient bedside. Paper may be the best solution.

• If so, try to find the best ways to deliver the paper-based documentation in the most concise manner and also offer electronic formats (reuse and flexible media output!).

Technology Lessons Learned

• Until people start working in the tools, there is only so much you can do with just the concepts and theories

• Identify a pilot project where you can test changing the content• We couldn’t change the content too drastically to follow the DITA

methodology because of increasing the workload to create a change list for regulatory requirements from our customers.

• Instead of writing content to fit the DITA model and our information architecture, we are changing DITA to somewhat accommodate our content (Note: we plan to go back and revise this for the next release)

• Don’t try to test all use cases with one pilot project. • This extends the pilot project which decreases the opportunity to

demonstrate quick wins, maintain a sense of urgency, and maintain deadlines

• Although we were able to test a lot with our one pilot project, there are some things that we still need to test, but mustcreate a new project because of timeline creep.

Business best practices & things to keep in mind

• Work cross-functionally to support the entire project• Streamline the documentation group to include English

development and deliverable localization team• Content creation and translation are not independent processes

and should be thought of as an integrated workflow

• Work closely with software localization team

• Engage all stakeholders in advance, including internal teams, translation suppliers, and reviewers

Technology best practices & things to keep in mind

• Implementing CMS/TMS tools gives writers more control over the content ownership• More difficult for SMEs and reviewers to make minor

changes because it could impact many different deliverables.

• Use technology to help manage content consistency and ensure compliance

Foreseeable Next Steps

• Expand the GEM environment to additional departments• Training, Quality Management, Marketing, Service

Technicians, etc.

• Performing ECO upstream at the topic level• By ECOing our topics, then we can create deliverables in

even less time.

• Identifying additional methods for delivering content to our users• HTML/Web, PDA/Mobile devices, embedded help, CD, etc.

Questions?