;   Medical Translation Insight: A quality approach to vendor qualification - ForeignExchange Translations

A quality approach to vendor qualification

Caveat emptor ... buyer beware. As outsourcing within the device and pharmaceutical industries has grown ten-fold in the past 20 years, this 200-year-old doctrine is as relevant as ever.

And as this trend is expected to continue - and even accelerate - industry and regulators have to grapple with the challenges brought on by the growing number of contract services companies offering everything from process validation and facilities qualification to contract manufacturing and compliance expertise. On the other hand, regulatory agencies have to monitor GMP activities within the firms that contract vendor services and goods.

Essentially, everybody involved in the development, manufacturing, and sale of drugs and devices is affected, making vendor qualifications a hot topic and leading compliance issue. Providers of medical translation services are no exception. More and more drug and device companies are improving the process and compliance of their translation supplier qualification process.

We have found two good resources to aid both supplier management staff at medical device and pharmaceutical companies as well as suppliers.

Buyer Beware: A Quest for Vendor Qualification details the "Q.U.E.S.T." approach to vendor qualification:

QUEST approach to vendor qualification

The five-step process (question - understanding - evaluation - site audit - tracking) is robust enough to help buyers accurately determine whether or not a vendor can provide the necessary goods or services to the required standards. It is also flexible enough that it can be adjusted to just about any company or industry.

The second resource is Marion Weinreb's excellent presentation QA Oversight of Vendor Management. Her audio conference takes a close look at the challenges and success criteria of managing vendors. What's especially helpful is that she provides hands-on information on how to develop, negotiate, and monitor a robust quality agreement.

Poor purchasing decisions negatively affect quality, compliance and financial performance. Medical device, pharmaceutical, and translation companies alike have a shared vested interest in tightly managing the their supplier pool.

ForeignExchange's METRiQ quality system provides medical device and pharmaceutical companies with measurable, known medical translation quality. To learn more, contact ForeignExchange Translations.


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