The Localization Manager’s AI Cheat Sheet
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・11 min read
There aren’t many industries where “getting it right the first time” is more important than in the life sciences sector. That’s why quality is so important—it helps medical professionals to deliver better care and patients to understand their choices and make better decisions.
In life sciences, where factors include patient safety, regulatory compliance, and minimizing risk, language services are vital to bridge the gap between innovation and the real-world use of medical products, services, and devices.
Quality isn’t just a box on a checklist for us; it’s a fundamental principle that guides our entire workflow from the initial step to the final delivery. Whether it’s translating pharmaceutical instructions, medical device manuals, or clinical trial documentation, quality remains top of mind throughout our processes.
Because we’re deeply immersed in life sciences every day, we’d like to provide some insight into how quality works at Argos. We’re eager to share more about our approach and what we’ve learned, from meeting complex legal requirements to creating workflows that streamline both operations and compliance.
At Argos Multilingual, we live by the mantra of “Quality at Source.”
This methodology ensures that each step, from initial content selection through translation to final delivery, follows our high standards of ISO-certified precision. Quality is embedded in every phase, so potential issues are addressed early, processes are streamlined, and the final content meets the rigorous requirements of our life sciences clients.
Quality at Source also mandates that all participants in the project are directly responsible for the quality of their work. This approach minimizes the need for revisions and guarantees that the final output not only meets, but often exceeds, the expectations of our life science clients.
Moreover, our emphasis on the strategic use of technology, like client portals and translation memories (TM), further enhances our workflow efficiency and quality control. Through a structured feedback process, we continuously learn from each project, implementing improvements that refine our approach and consistently provide high-quality deliverables.
The first step toward quality is the careful selection and screening of our linguists. Our supply chain identifies suitable translators based on their education and experience. Next, there is a test translation to ensure that the linguist is technically capable and has the appropriate subject matter expertise. If successful, the linguist is onboarded, and their work regularly checked as a part of final verifications and language quality assessments (LQA).
Additionally, linguists use many tools and assets to ensure consistency and accuracy. Client-specific glossaries, style guides, and translation memories all contribute further to high-quality translations.
“When a project starts, we prepare new instructions for every source document that is submitted,” said Barbara Furgoł, Life Sciences Quality Lead at Argos Multilingual. “We look for anything that may be unclear to translators and things that need to be clarified, like whether product names should be translated or left in English. This proactive approach helps to minimize queries later during the project.”
Following the completion of translation, quality really comes into play during the quality assurance (QA) phase of a project. This stage includes detailed reviews against the source material to confirm accuracy, appropriate use of terminology, and compliance with life sciences industry standards. Both cutting-edge technology and expert human insight are used throughout the QA process for a comprehensive examination that ensures conformity to the original text.
When an issue is identified, we take a highly structured approach to feedback. This process involves detailed communication with the translation team about the nature of the issue and guidance on how to avoid similar problems in the future. This continuous improvement process not only perfects the project in progress, but also enhances the skills of our linguists for future assignments.
Finally, Argos adheres to a final verification step in alignment with ISO standards for life sciences content. Depending on the unique needs of each project, varying levels of scrutiny are available to match client and regulatory demands. This hierarchy of checks may include verifications based on the client, the subject matter, the product or deliverable, and the target language, among other factors.
Additionally, in industries where precision and quality are paramount such as medical devices or the pharmaceutical sector, we recommend that companies consider a quality review by a subject-matter expert (SME), in-country reviewer (ICR) or an independent third-party vendor. This extra layer of scrutiny can offer a fresh perspective, ensuring that the translated content not only meets but exceeds industry standards and regulatory requirements. The reliability and accuracy of the project are improved, providing extra confidence in the final deliverables.
One of the risks of such strict attention to detail is losing sight of how devices, products, and instructions affect people in the real world. That’s why Argos aligns our detailed work on language and compliance with a larger goal: clear communication that improves and saves lives.
“What sets Life Sciences apart is this absolute need to make sure that you’re compliant with the entire regulatory framework,” explained Karl Pfeiffer, Quality Lead and Senior Terminologist. “It’s a lot different from a manufactured widget with a minimal level of risk.”
For linguists, this means being able to remain compliant with an ever-changing set of worldwide regulations, such as the EU’s MDR and IVDR, as well as client-specific nuances.
“Both sides of the job are important,” said Pfeiffer. “Their task is to know the client, the product, their mission, and have the best possible expertise about what the client is doing. Simultaneously, they also have to keep the big picture in mind. Not only do our linguists keep current with regulatory requirements and training, but we also make sure in the best possible way that they understand that their work is helping healthcare providers use a medical device or lab staff to operate diagnostic equipment.”
Both early and continuous collaboration is a key part of our process. By fostering a dynamic partnership between our team, clients, and linguists, the quality of every life sciences project is improved.
“Good communication between the client’s team and our team is very important,” said Furgoł. “We can better understand their pain points and objectives, make recommendations, and proactively help prevent little issues from becoming big issues.”
For example, in a project for a medical device manufacturer (MDM), Argos provided a centralized review service to ensure quality and consistency. This process included test translations, customized workflows, and direct translator feedback. The result was markedly better content quality, meeting the strict standards of the project.
Even when things go awry, there are always opportunities for collaboration. CAPAs, or Corrective and Preventive Actions, are systematic steps taken in response to an issue in the translation process. Although typically viewed as a setback, CAPAs provide a structured approach to both address the immediate problem and create processes to reduce the risk of a future issue.
“While situations that require corrective action are rare by design, we strive to make the best of it,” said Pfeiffer. “It’s a really good way to investigate and determine what can be learned to improve your processes, making it a valuable exercise.”
At Argos Multilingual, our commitment to excellence is fueled by a proactive approach to improvement, leveraging feedback, and the potential of technologies like AI and machine learning to enhance accuracy and efficiency, while always keeping the human touch.
“While Argos is significant in the industry, we’re small enough to care about each of our clients,” said Pfeiffer. “That’s not going to change because we’re not only skilled to provide the best quality to our clients, but we’re passionate about it, too. I know many people with cardiovascular issues, so when I work on the instructions for a pacemaker, I’m passionate about it. I know many people who have been diagnosed with cancer, so when we work on treatment therapies, it matters.”
Our teamwork, technology, and versatility give us the tools to meet the needs of both patient safety and regulatory approval. But it’s the people behind the projects that really make the difference when it comes to quality.
To find out more about Quality at Source, watch our webinar Quality At Source: The Foundation to Success or contact us to see how we can help support your translation quality.
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