How to Enforce Standards in Life Sciences Documentation
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How to Enforce Standards in Life Sciences Documentation



Presented by Suzanna Mescan and Andrew Thomas at Documentation and Training Life Sciences, June 23-26, 2008 in Indianapolis....

Presented by Suzanna Mescan and Andrew Thomas at Documentation and Training Life Sciences, June 23-26, 2008 in Indianapolis.

Today, life science industries are experiencing tremendous pressure from regulatory commissions to conform to mounting numbers of industry standards. At the same time, they must always look to improve cost and time efficiencies and maintain the highest levels of quality and safety.

All of these pressures present a daunting challenge for companies who then need to publish critical information into multiple languages around the world. They can no longer rely on paper-based, manual business processes that are time consuming and error prone.

Fortunately, new technologies can improve your ability to manage and translate information into multiple languages through a set of seamless business processes and best practices.



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How to Enforce Standards in Life Sciences Documentation Presentation Transcript

  • 1. How to Enforce Standards in Life Sciences Documentation Suzanne Mescan Vasont Systems Andrew Thomas SDL
  • 2. Agenda
    • Enforcing and conforming to standards in life sciences documentation
      • The issues
      • The solution
      • Best practices
      • Results
  • 3. The Issues
    • Scattered content
    • Manual search for content
    • Repeated editing efforts
    • Isolated production environment
    • Inconsistent content
    • These issues lead to:
      • Noncompliance with regulations
      • Delayed product launch
      • Product line shut down
      • Increased complexity with more languages
      • Cost the organization $$ millions $$
  • 4. The Solution
    • Create a single collaborative, controlled environment for the writing/editing, translation, and publishing processes
  • 5. Best Practices to Enforce Standards in Life Sciences Documentation Centralize Source Content Automate Processes Manage Terminology Implement Reuse Maintain an Audit Trail
  • 6. Best Practices #1: Centralize Source Content
    • Centralize source content into a single repository
      • How? Component content management (CCMS)
      • Store all types of content together: text, graphics, multimedia, translations, documents, metadata
      • Only one copy of content ever exists
      • Easy to search
      • Easy to update; globally change content
      • One point of integration for various tools
      • Writers gain awareness of existing content and consistency
  • 7. Best Practice #2: Automate Processes
    • Use the appropriate tools to upgrade and automate your processes
    • Automate tasks within systems to control processes and save time
    • Integrate systems to create a seamless automation chain throughout the entire content lifecycle
  • 8. Content Lifecycle Publisher Author Translator Editorial Manager Regulatory & Legal Review LSP Manager Q.A. Localization Manager
  • 9. Best Practice #3: Manage Terminology
    • Why is terminology important?
      • Content today is global content, from the start
        • Content is provided through the internet so anyone can read it
        • Some of that content is also translated
        • Content is often written by non-native speakers
      • Content has different readers
        • Technical and non-technical
        • Native and non-native English readers
  • 10. An Example
    • Multiple terms used across the business
    • Important for legal and regulatory compliance to use terms consistently
    • Extract and define correct terms
    Engineer uses one term Author uses another Different terms can cause confusion amongst users
  • 11. Best Practice #3: Manage Terminology
    • What is terminology management?
      • Ensure terms are used consistently with agreed corporate standards
      • Make sure authors and translators all work from the same agreed terms
      • Leverage industry-controlled terminology throughout the entire process
  • 12. The Power of Consistent Terminology
  • 13. Best Practice #3: Manage Terminology
    • What do you get when you properly manage your terminology?
      • Significant business impacts
        • Brand perceptions
        • Customer satisfaction
        • Regulatory and legal compliance
      • Source content impacts the quality of translated output
  • 14. The Business Impact
    • “ There is no common vocabulary at Microsoft… Our lack of standardization undermines our trustworthiness.”
    • Craig Mundie, Chief Technical Officer
    • Solution: Trustworthy Computing initiative
    “… The customer expects to see consistent and timely information regardless of where and how it is published.” Alison Toon, Translation & Localization Manager Solution: One World initiative “ New products need to be launched simultaneously across all markets… Our quality and consistency were suffering, leading to poor communications with customers and potentially damaging the Philips’ brand.” Luuk de Jager, Global Content Management Senior Manager Solution: One Face to the Customer initiative
  • 15. Best Practice #4: Implement Content Reuse
    • Implement reuse through componentization
      • “ Recycling” content through reuse
      • Determine the level of componentization appropriate for your content and business processes
      • Control accuracy through global change
    • Controlled authoring
      • Ensure new content is consistent with previously written and translated content
      • Know the impact of style changes on translation costs
      • Option to only make changes when there is not a 100% match in translation memory
    • Centralized Translation Memory (TM)
      • Reduce downstream costs of translation
  • 16. Monitoring Content Reuse
  • 17. Translation Memory Leveraging Illustration of the value of leveraging translation memory across multiple business units
    • Demonstrates that:
    • Translation content can be leveraged across the organization
    • Centralized and automated TMs ensure effective reuse of translated data and maximum cost savings
  • 18. Best Practice #5: Maintain an Audit Trail
    • Who? What? When? Where? Why? How?
    • Track content, versions, metadata, comments, and processes during creation, edit, and translation phases
  • 19. Best Practices Recap Centralize Source Content Automate Processes Manage Terminology Implement Reuse Maintain an Audit Trail
  • 20. Results
    • Provides controlled writing environment
    • Simplifies sharing and reuse of content and translations
    • Consolidates content to a single source for multi-channel delivery
    • Accelerated time-to-market
    • Roll out new products faster
    • Reduced production, translation, and localization costs
    • Greater quality control; accurate content in all languages
    • Greatly enhances compliance with regulations
  • 21. Thank you! Suzanne Mescan Vasont Systems Andrew Thomas SDL