DOXPUB 13-0008-SOP

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