According to Crimson Audit, Review, & Consulting, in over 4 years, their most popular post (by far) has been this: Labeling Errors are Leading Cause of Device Recall.
With the growing interest in XML publishing in the medical device industry, this information is now more relevant than ever. Our Astoria and Vasont divisions provide validated systems for device makers like GE Healthcare, Medtronic, and J&J because these systems can reduce localization costs by 40%…but, as you might guess, this level of savings comes at a cost.
The strength of these systems is that they manage content in a “single source” – there is one version of a content chunk (topic) which is reused in other publications or channels. However, if the content contains an error (in the English source or translated target), that error gets replicated out multiple times – this is a classic “propagation risk” and it has very real implications for labeling accuracy and device recall.
The best solution is also a classic: the quality systems principle of “quality at the source”. For translation, it means that appropriate risk management must be employed to produce XML -based translated content. This not only minimizes propagation risk, it also reduces the risk of device recall due to labeling errors.