Forum posts to 'Statutory and Regulatory Requirements'

Translation/localization vendor audits

dhdunn — Fri, 12 Feb 2010 15:51:11 -0700

Most FDA-regulated companies have built into their quality processes auditing of their various vendors. And, of course, this can include vendors who provide translation and localization services.

While audits are usually quite time consuming for both the client company and the vendor, they provide an excellent opportunity for both to enhance their business partnership. Audits provide not only a view into the vendor's business practices, but also into the receiving end on the client side. Translation/localization companies who take advantage of this opportunity stand to gain a great deal in terms of their knowledge of their clients.

And, as with any good audit, the opportunity for improvements are often excellent. Client-specific audits, as opposed to more general ISO-type audits, allow a vendor to see what areas of their process might be enhanced to meet and exceed their client's business needs.

Excellent communication is key to a successful audit, especially prior to the audit. A good understanding of the expectations of all parties involved is the foundation for the audit being efficiently executed, and for meaningful results to be gained.

Please post any experiences you may have had, either on the client side or the vendor side, of client-to-vendor audits. Thank you!!

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Choosing Features for Regional Release

Nathen — Wed, 09 Dec 2009 23:39:37 -0700

Penetrating a regional market depends on good localization. A free add-on will give your product an edge in the market. The add-on might even be distributed with a free introductory product as in inroad for accessory sales.

In the world of regulatory control, investing in good localization for a free product is an even harder ROI to calculate. The question becomes, how to justify the budget to localize features when faced with regulatory testing costs?

Take reporting software for medical devices as an example. With budget being spent on the regulatory testing for additional features, it can restrict what is left for quality localization. Testing a rarely used report can consume a budget until it will not allow work on consistent terminology or clear user interface elements confirmed by subject matter experts. If the feature will be rarely used, is it cost effective to include it when it will leave the customer without a clearly navigable interface?

Again, this problem is compounded with add-on software to a core product. It is difficult to justify localizing a successful "extra" if there is not a clear dollar value assigned to the ROI. This takes us to a core value of internationalizing the product: identifying regional needs. If a region is less interested in the feature being part of the product and more interested in quality localization, it is:

1) less money
2) better spent
3) higher ROI
4) more regions

Does anyone have experience making these decisions in choosing features for regional release?

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Re: Translation Certificates

swisschris — Thu, 03 Sep 2009 11:12:50 -0600

Hi Brian,
I'm a notary public at ENLASO and here we go with a sample certificate. Hope this helps.
Cheers,
Chris

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Re: Translation Certificates

Brian — Wed, 02 Sep 2009 11:41:24 -0600

Can we please see a sample certificate (no real names of course) to get an idea of what kind of information is required? Thank you!
--Brian

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Translation Certificates

dhdunn — Mon, 24 Aug 2009 16:37:17 -0600

Translation Certificates are a very simple way to document compliance with a company's quality requirements. Many companies in the medical space use Translation Certificates as a part of their FDA audit trail. ENLASO can assist with Translation Certificates, and can provide notarized Certificates as well.

It is very helpful to let your ENLASO Project Manager know at the beginning of a project whether or not Translation Certificates will be required at the end of a project. S/he can provide a template certificate for your review, and the certificate itself can usually be modified to include any information required by the client company.

Certificates can be faxed to our client company contact, scanned to PDF and then emailed, or even mailed through the post. Please let your ENLASO Project Manager know the required delivery method for the Translation Certificates you require.

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