Quality control in life sciences translations

Wendy Farrell 05 Dec 2023 4 mins
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Quality Control in Life Science Translation

Quality control (QC) in life sciences translation is not just about language fluency; it's about the precision and accuracy necessary to convey critical information that can have profound implications on public health, safety, and scientific integrity. Life sciences, encompassing fields such as biotechnology, pharmaceuticals, and healthcare, require a level of translation fidelity that leaves no room for error. Miscommunications or inaccuracies in this context can lead to misdiagnosis, regulatory submission rejections, or even endanger patient lives. RWS recognizes the gravity of this responsibility and upholds a gold standard in translation services tailored to the life sciences industry. RWS’s dedication is reflected in its robust processes that bridge linguistic excellence with technical precision.

Why quality control is imperative in life sciences translation

Life sciences translation goes beyond mere word-to-word conversion. It's about accurately conveying complex scientific concepts, medical terminologies, and regulatory nuances in a culturally sensitive and legally compliant manner. A minor misinterpretation or mistranslation can have far-reaching consequences, from jeopardizing patient safety to causing legal repercussions for life sciences organizations.

Ensuring accuracy and consistency: A primary goal of QC in life sciences translation is to ensure accuracy and consistency across all translated materials. This entails a meticulous review process to identify and rectify any discrepancies, ambiguities, or errors that could potentially mislead the target audience or misrepresent the original message.

Adherence to regulatory standards: Life sciences translations must comply with a myriad of local and international regulatory standards. Quality control processes ensure that translations are in line with the strict regulatory frameworks, such as those laid out by the FDA, EMA, or other relevant bodies, thus safeguarding organizations against legal pitfalls and fostering trust among stakeholders.

Methodologies employed in quality control:

Quality control in life sciences translation is a multi-faceted process that typically involves a number of methodologies to ensure accuracy and consistency. Here are some of the methodologies involved:

Standard translation: This is a straightforward process involving three major steps and is completed by three separate linguists: a translator, an editor, and a proofreader. This method ensures that the translation is checked at multiple levels by professionals with different roles​​.

Back translation & reconciliation: After the initial translation, the text is translated back into the original language by a second translator. Any discrepancies between the original and the back translation are reconciled to ensure the translation's accuracy.

Linguistic validation: This is a more comprehensive process where the translated document is reviewed and tested to ensure it conveys the correct terminology nuances and is culturally appropriate for the target audience​.

Two-step translation and editing process: Each project is worked on by at least two translators per language, where one performs the initial translation and the other carries out the editing. This two-step process allows for an additional layer of scrutiny.

Quality management elements: The skills and expertise of the translator are pivotal. Translators must have the necessary language skills as well as specialized knowledge in the relevant life sciences field to ensure high-quality translation.

These methodologies underscore the importance of a rigorous quality control process in life sciences translation, given the specialized and often regulatory nature of the content. Each step in the process, from translation to final proofreading, is designed to minimize the risk of errors and ensure that the final product is both accurate and usable in its intended context.

How does RWS ensure quality control?

RWS employs a comprehensive range of methodologies to ensure the highest quality in life sciences translation. These methodologies are documented as standard operating procedures, policies, or work instructions and are part of an ISO Quality Management System that monitors and certifies the work done​.

  • Linguistic validation (LV): This involves a top-tier, three-step process. The first part consists of ‘harmonizing’ multiple forward translations into a single, optimal translation. The second part includes a review where a new translator back-translates the harmonized version, which is then analyzed and reconciled. The third part, cognitive debriefing, tests the translation for conceptual precision and cultural appropriateness with native-speaking subjects or patients from the target area. 
  • ISO-certified workflows: RWS's workflow includes six different Quality Assurance checkpoints throughout a four-phase process, all of which are overseen by a qualified team of Project Managers. This structured approach ensures clients receive high-quality content that meets deadlines and adheres to the highest customer service standards​. 
  • Compliance verification: The company verifies compliance with regulations like the Medical Device Regulation (MDR), optimizes the Instructions for Use (IFU) creation and translation processes, and handles the in-country review process to ensure the translation meets all regulatory requirements​. 
  • Machine translation: RWS uses state-of-the-art translation technologies, including in-house developed AI-driven machine translation engines, to optimize processes and reduce cycle times. These engines are used with human expertise to ensure the best fit for the client's needs and the content's risk level​​.

Through these methodologies, RWS ensures that life sciences translations are not only linguistically accurate but also comply with the regulatory and cultural nuances required in this highly specialized field. The integration of technology with human expertise is key to maintaining the high standards that RWS is known for in the industry.

Future directions in quality control

As RWS looks to the future of quality control in life sciences translation, advancements in technology, particularly in artificial intelligence and machine learning, are expected to play a pivotal role. These innovations will augment human expertise, enhancing efficiency and precision. Collaborative translation platforms will facilitate real-time updates and consistency, which is crucial for keeping up with the rapidly evolving regulatory standards.

Moreover, RWS is committed to ongoing professional development for our language specialists to ensure they remain at the forefront of scientific and regulatory changes. This commitment, coupled with a global trend towards regulatory harmonization, positions RWS to continuously refine its QC processes, ensuring that translations are not only linguistically and scientifically precise but also globally compliant.

Wendy Farrell RWS
Author

Wendy Farrell

Senior Director of Content Development
Wendy Farrell is the Senior Director of Content Development for RWS’s Regulated Industries division. In this role, she leads a team that creates and delivers compelling content for the life science, financial and legal industries, including articles, presentations, white papers, research and thought leadership for professionals in highly regulated industries. With over 15 years spent in the localization industry, Wendy has collaborated with experts and helped organizations build more meaningful connections with their global audiences, through her background in global marketing, sales, solution development, multimedia and training.
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