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Loc world 2006 10 ocd and foreignexchange

ForeignExchange Translations
ForeignExchange Translations

Translation memory challenges in a compliance environment (Ortho-Clinical Diagnostics and ForeignExchange Translations, June 2006, Localization World Montreal)

1 of 17
Translation memory challenges in a compliance environment Jim Niziurski, Ortho-Clinical Diagnostics Sonia Monahan, ForeignExchange Translations, Inc.
Agenda Introduction Requirements Overview Client Case Study Customer profile Management of linguistic assets In-country review requirements Performance reporting and certification requirements Questions & Answers
1. Introduction
Introduction Jim Niziurski has worked in the medical diagnostics industry for 25 years. He is a certified Project Management Professional (PMP). His current responsibilities include management of global labeling strategy for Ortho-Clinical Diagnostics (a Johnson & Johnson company). Sonia Monahan is a localization industry veteran of 15 years, with an extensive background in medical localization. She is currently Vice President of Operations for ForeignExchange Translations.
2. Requirements Overview
Requirements Corporate requirements FDA regulations EU regulations, including: IVD Directive (98/79/EC) EN 1041 (information provided with medical devices) EN 980 (medical device symbols) EN 375 (labeling IVDD for professional use) EN 376 (labeling IVDD for self-testing) ISO 15223 (medical device symbols)
Requirements Control and management of linguistic assets Requirements for use of multiple language service providers Translation validation and in-country review requirements Performance reporting requirements Translation certification
3. Case Study
Linguistic assets Challenge #1 Work is divided by language across two suppliers. Consistent TM SOP approach required for both suppliers. Solution #1 Create joint OCD and supplier translation memory SOP to ensure streamlined sharing and reuse of TMs. Individual language TMs maintained by supplier who is the owner for that language.
Linguistic assets Challenge #2 Changes to both source and translated content must be controlled. Changes to English (source) content controlled through OCDs systems Suppliers must provide audit trail for all changes to existing translated segments.
Linguistic assets Solution #2 Implement TM SOP. Implement process for controlling creation of duplicate translations, when they are required. Create custom utilities, allowing leveraging from legacy TM, while highlighting for reviewers changes to 100% matches from the previous version of the same document. Audit trail ensures that all changes to 100% matches are reviewed and approved by OCD.
ICR and Validation Challenge #3 Audit trail required for all changes to existing translations. Need to focus reviewers on identifying errors rather than stylistic changes, and on reviewing only that which has changed since the last approved version. Validation of adherence to glossary, boilerplates and style guides.
ICR and Validation Solution #3 Utilize automated tools to validate use of glossary translations in target languages. Implementation of translation metrics to quantify results (SAE J2450). Integration of online terminology management tool, which provides approval and audit trail.
Performance reporting Challenge #4 Performance reporting required for pricing, linguistic leveraging, linguistic quality, and on-time deliveries of both ForeignExchange and OCD reviewers. Requirement of translation certificates with each project delivery (confirmation that the prescribed translation process was followed).
Performance reporting Solution #4 Utilize integrated reporting features of FXTracker to provide ongoing visibility into ForeignExchange performance. Online and customized reporting implemented. Translation certification integrated into project requirements and delivery package.
4. Questions & Answers
Questions? Jim Niziurski Ortho-Clinical Diagnostics Tel. +1. 585.453.3443 jniziurs @ ocdus . jnj .com Sonia Monahan ForeignExchange Translations, Inc. Tel. +1.303.926.7177 ext. 105 [email_address]

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Loc world 2006 10 ocd and foreignexchange

  • 1. Translation memory challenges in a compliance environment Jim Niziurski, Ortho-Clinical Diagnostics Sonia Monahan, ForeignExchange Translations, Inc.
  • 2. Agenda Introduction Requirements Overview Client Case Study Customer profile Management of linguistic assets In-country review requirements Performance reporting and certification requirements Questions & Answers
  • 4. Introduction Jim Niziurski has worked in the medical diagnostics industry for 25 years. He is a certified Project Management Professional (PMP). His current responsibilities include management of global labeling strategy for Ortho-Clinical Diagnostics (a Johnson & Johnson company). Sonia Monahan is a localization industry veteran of 15 years, with an extensive background in medical localization. She is currently Vice President of Operations for ForeignExchange Translations.
  • 6. Requirements Corporate requirements FDA regulations EU regulations, including: IVD Directive (98/79/EC) EN 1041 (information provided with medical devices) EN 980 (medical device symbols) EN 375 (labeling IVDD for professional use) EN 376 (labeling IVDD for self-testing) ISO 15223 (medical device symbols)
  • 7. Requirements Control and management of linguistic assets Requirements for use of multiple language service providers Translation validation and in-country review requirements Performance reporting requirements Translation certification
  • 9. Linguistic assets Challenge #1 Work is divided by language across two suppliers. Consistent TM SOP approach required for both suppliers. Solution #1 Create joint OCD and supplier translation memory SOP to ensure streamlined sharing and reuse of TMs. Individual language TMs maintained by supplier who is the owner for that language.
  • 10. Linguistic assets Challenge #2 Changes to both source and translated content must be controlled. Changes to English (source) content controlled through OCDs systems Suppliers must provide audit trail for all changes to existing translated segments.
  • 11. Linguistic assets Solution #2 Implement TM SOP. Implement process for controlling creation of duplicate translations, when they are required. Create custom utilities, allowing leveraging from legacy TM, while highlighting for reviewers changes to 100% matches from the previous version of the same document. Audit trail ensures that all changes to 100% matches are reviewed and approved by OCD.
  • 12. ICR and Validation Challenge #3 Audit trail required for all changes to existing translations. Need to focus reviewers on identifying errors rather than stylistic changes, and on reviewing only that which has changed since the last approved version. Validation of adherence to glossary, boilerplates and style guides.
  • 13. ICR and Validation Solution #3 Utilize automated tools to validate use of glossary translations in target languages. Implementation of translation metrics to quantify results (SAE J2450). Integration of online terminology management tool, which provides approval and audit trail.
  • 14. Performance reporting Challenge #4 Performance reporting required for pricing, linguistic leveraging, linguistic quality, and on-time deliveries of both ForeignExchange and OCD reviewers. Requirement of translation certificates with each project delivery (confirmation that the prescribed translation process was followed).
  • 15. Performance reporting Solution #4 Utilize integrated reporting features of FXTracker to provide ongoing visibility into ForeignExchange performance. Online and customized reporting implemented. Translation certification integrated into project requirements and delivery package.
  • 16. 4. Questions & Answers
  • 17. Questions? Jim Niziurski Ortho-Clinical Diagnostics Tel. +1. 585.453.3443 jniziurs @ ocdus . jnj .com Sonia Monahan ForeignExchange Translations, Inc. Tel. +1.303.926.7177 ext. 105 [email_address]