Description
Summary:
Describes procedures to verify that translations from English to another language of controlled documents, with a possible impact and/or containing claims on safety and performance of a device, are correct and communicate the proper message. Apples to all controlled documents with a possible impact and/or containing claims on safety and performance, including Operator Manual, Package Inserts, software messages, marketing documents, and any other applicable document. Does not cover documents generated in a foreign language (e.g. German price offers made by the German sales force) or documents with no possible impact on performance and/or safety (e.g. meeting invitations, price offers). Includes provisions for requesting translations and criteria for selection of translators and reviewers.
Included Sections:
Purpose, Scope, Responsibility, References and Applicable Documents, Materials and Equipment, Health and Safety Considerations, Documentation Requirements, and Procedures
Included Attachments/Appendices:
Translation Request Form
About This Document:
This is not a generic template, it's a 3-page procedure that was actually created and used in the Sales & Marketing operations of a FDA-regulated establishment. The company-specific information (names, addresses, some images, proprietary product information, etc.) has been redacted but the content and format have been largely preserved.
Reasons to Buy:
- Use it as a starting point for your own documentation project
- Compare the quality of your documents against your industry peers
- Learn what other companies in your industry are actually doing
Who Will Benefit:
- Sales & Marketing Managers
- Regulatory Affairs Managers
- Executive Management
Product Details
- Edition:
- 1.0
- Published:
- 08/01/2007
- Number of Pages:
- 3
- File Size:
- 1 file , 290 KB
