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  • 1.  Translation Services

    Posted 12-May-2015 10:24
    I am looking for some guidance on translation.  We right now require that any translation that is completed needs an accompanying Certificate of Compliance from the translator stating that they translated the english to whatever language and it says the same thing.  I have some people who would like to get rid of that requirement, I however remember it being a regulation but I can't find the reference. Can anyone help?

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    Keri Froese RAC
    Quality Assurance Specialist
    Ottawa ON
    Canada
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  • 2.  RE: Translation Services

    Posted 12-May-2015 10:59

    Please refer to 21 CFR 314.50(g)(2) or you may download 21 CFR Part 314 in PDF at http://fdaguidance.net/rac-exam/

    As a general matter, Certificate of Compliance serves as one of key quality attributes attached to the document(s).  

    To show "verified to be complete and accurate," Certificate of Compliance is one way to show it.  

    Unless you have any equivalent or better way to do it, I would highly recommend you keep it.  

    At least you can/should voice it, but then if you have to fight against the wall, please just let it go.

    ____________________________________________________________
    Dr. David Lim, Ph.D., RAC, ASQ-CQA 
    President and CEO | REGULATORY DOCTOR
    Phone (Toll-Free): 1-(800) 321-8567
    "Knowledge is power only when it is practiced and put into action." - Regulatory Doctor



    Original Message


  • 3.  RE:Translation Services

    Posted 13-May-2015 07:38

    Many companies use certified translation services as their process but don't require a formal statement as much as having the translator's approval of final copy (hard copy or e-signature). Sajan, Transperfect and Omnilingua translations services are just some out there. I have only had Regulatory Authorities (like FDA) require a formal statement of accurate and complete translation of something submitted to them (like foreign literature or studies). This statement is included in the submission accompanying the item translated.
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    Ginger Cantor RAC
    Centaur Consulting LLC, Owner and Principal Consultant
    River Falls WI
    United States
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    Original Message