CSOFT’s Uwe Muegge Published an Article in BioProcess International on Terminology Management

March 11, 2010

According to CSOFT’s article in BioProcess International, effective terminology management is an essential risk-management strategy for biopharmaceutical organizations. With a terminology management strategy in place, organizations of all sizes can use the same terms consistently within and across the various documents and labeling that accompany a product or service. Because such documents are typically created in a collaborative environment, terminology management is the most efficient solution for ensuring that the organization as a whole uses the same terms to describe the same features and functions.

With comprehensive, project-specific “termbases” available at the beginning of a project, team members are free from the tedious task of researching terms on their own. The availability of a project termbase also reduces the risk of multiple coworkers inadvertently coining multiple terms for the same feature, which, if undetected, can confuse users or cause unnecessary expense and delays for terminology harmonization later on.

More Efficient External Communication: It is a defining characteristic of the biopharmaceutical industry that its products and services typically have an immediate impact on the lives and well-being of people they treat. So any communication with end users — whether clinicians or patients — must be as comprehensible as possible to ensure that documentation and labeling do not interfere with the intended use of a product or service. Consequently, labeling and instructions for use must not only be terminologically consistent, but their writers must also use the most common and most easily understood terms.

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About CSOFT Health Sciences

CSOFT Health Sciences, leaders in clinical trial localization, provides AI/ML-enabled medical translation services for all phases of the drug and medical device product lifecycle, from development to post-launch. We also specialize in DCT solutions, linguistic validation, and CTD/eCTD submissions with the FDA, EMA, and NMPA. Our operations are certified in ISO 17100:2015, ISO 9001:2015, and ISO 13485:2016, ensuring our customized solutions meet the rigorous regulatory requirements of MMA, NDA, CTA, and Medical Device Application submissions. www.csoftintl.com

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