It is mandatory in the European Union, the United States, and recently China. In the EU, once the European Commission grants the marketing authorization, it is valid in all EU states, Iceland, Norway, and Liechtenstein.

The Chinese government revised its Drug Administration Law a couple of years ago and introduced the Marketing Authorization Holder system.

Another important pharmaceutical market, India, does not use the term “marketing authorization”. However, there is a stringent regulatory process in place to approve the import, manufacturing, sale and distribution of drugs in India.

What comes under the purview of a marketing authorization?

All the critical information and documentation on the product such as Summary of Product Characteristics (SmPC), IFUs, Patient Information Leaflet (PIL), label annex, any product updates, and clinical tests and trials need to be submitted for the marketing authorization. There are specific and strict requirements on how each of these needs to be documented and presented to the regulatory authority.

In the European Union, all of the above documentation also needs to be in the 23 official language(s) of its member states. This adds more layers of complexity and multiplies the time and effort required to obtain an authorization.

Challenges with multi-language marketing authorizations

Voluminous content: You need to submit multiple documents at the different stages of the application process for a marketing authorization. The stages could vary between different regulatory agencies. In the EU, you need documents for pre-submission, submission, and application and evaluation stages. Consider that all of these documents may need to be updated or changed if there are any changes with the product. This is not just a lot of content, but content residing in many files and possibly different file formats and in multiple languages.

Several cycles of validation by the company: The translated content needs to be reviewed by people from different departments in the company because of the nature of the content. While the translated clinical trial data will need to be reviewed by the R&D or Regulatory team, marketing may be responsible for packaging labels. Even within the same type of content, sometimes companies arrange multiple reviews. As a result, there is a lot of back and forth, taking up valuable time.

Strict timelines: The timeline for translation for marketing authorization is usually very strict. However a well-thought out process allows for coping with such turnaround.

Rejection of application: Authorizations may sometimes be refused because of unclear documentation or erroneous translation. This calls for re-doing the entire work and can become expensive, delay market entry, and cause substantial revenue loss.

Localization of the authorization: Some countries, such as Sweden, in the EU may need more documentation. These may be tougher to fulfill because they may need more specific information than the EU standard. It is obviously more time-consuming and also needs intimate domain knowledge.

How a multilingual agency can help

Multilingual agencies with expertise in marketing authorizations are an indispensable partner in your journey to the global pharmaceutical market. They add value in the following ways:

1. Centralized, professional handling of files. Usually, many pharma companies don’t use content management systems (CMSes). This makes management of documents very difficult. However, with the use of a CMS, the translation agency can keep track of content in the cloud, thus eliminating the need for manual version management and reducing human touch points.

2. Specialist translation. The translation agency needs to be a veteran in this domain, so that they can handle the processes required for translation of the marketing authorization and have the required resources to do so. As machine translation cannot be used in this work, it needs to be entirely done by translators who are subject matter experts (SMEs). As the deadlines are too short and the content too niche, there is frequently no time for any research and learning on part of the translator. They have to hit the road running.

Building a network of such translators doesn’t happen overnight. The agency has to hand-pick these translators and then make sure they stay as a part of its network. All of this needs careful and attentive project management.

3. Streamlined validation processes. Quality assessment (QA) often shows the experience and domain knowledge of the translation company. It must ensure a very high level of accuracy, as any error can amount to a rejection of the application. But quality is dynamic and subjective. So, the multilingual agency must make sure everyone agrees on the expected levels of quality. It is also critical for the pharmaceutical company to form an internal central committee that will be responsible for all documentation work for marketing authorizations. This will avoid the multiple levels of validation.

As is clear by now, an MAA entails intensive effort and expenditure. Make sure you get it right the first time by partnering with a specialist multi-language agency.

Employee safety

In some countries, training programs must be in the language of the learner by law. The Occupational Safety and Health Administration (OSHA) of the United States Department of Labor requires employers to “instruct its employees using both a language and vocabulary that the employees can understand.”

When staff understand safety and usage instructions better, the number of accidents go down. It is especially important in industries such as mining, manufacturing, and aviation, to name a few. You need to warn and alert employees of hazards before it happens, give instructions on what to do if an accident happens, reporting instructions on the accident as well as what to do immediately after.

A properly localized training program uses terms that are understood clearly in that locale. It does not import terms from the source language if they might mean something different or make no sense at all. For instance, some languages may have words that sound the same but mean quite different things. The Spanish word intoxicado means poisoned, while the English word intoxicated means drunk or affected by some drugs. An expert linguist will know the difference, translate accordingly, and avoid potential accidents.

Clear and in-language safety instructions can save employees from injury, even death in some cases. It provides the company several benefits such as lower insurance premiums, avoiding productivity loss, greater employee confidence and satisfaction, and protection from liability suits.

As employees also become knowledgeable on how to use the machinery or follow safety processes better, it can result in minimal damage or wear and tear to equipment too. Take for instance the usage instructions for nuclear medicine involving equipment used to provide proton therapy. You can well imagine the risk in not translating the usage and safety instructions for such a machine. Nothing should be left to chance. We cannot assume that everyone who is using the machine has understood all the details, when the instructions are not in their mother tongue.

Better engagement, better learning

The students are more engaged when the study material is in their own language. They can understand and digest information faster and retain it better when they can learn in their native or preferred language.

It increases the accessibility of the learning program. The training content does not remain limited to the speakers of one language.

Localization allows you to create region-specific assessments if need be. You might be testing the employees in different locales on different things, or they may prefer a different assessment style.

Building a strong corporate culture and employee loyalty

A localized training program makes it more culturally acceptable. As localization does not stop at translation, the program will be attuned to the cultural and social norms of a locale. For instance, a thumbs-up sign might be perfectly acceptable in the United States but may make no sense in other places around the world. Or even worse, it can be considered rude in some cultures in Eastern Europe, the Middle East, West Africa, and Asia.

International employees may appreciate the fact that the company has taken the effort to translate the course into their language. This might motivate them to take the program seriously and achieve the goals. Creating multilingual and multicultural training.

It builds a strong corporate culture, as international employees become more aware of the company rules and ethics and understand the processes better. They also come to possess the same level of skills and knowledge as the employees at the company’s headquarters. It helps the employees feel more engaged and empowered.

Challenges with translation of clinical trial data

Lots of fragmented pieces of data. Clinical trials consist of many documents such as consent forms, patient questionnaires, patient diaries, clinical study protocols, investigator brochures, phase IV documentation, clinical study reports, and others. A single project can have hundreds, if not thousands, of such documents. This then has to be translated to numerous languages in which the trial is to be done. Once the trial is done, the data have to be translated back into the source language. So, it’s not just lot of data, but data that lives in many documents.

As data is the content that needs to be translated, accuracy and relevance become a challenge. The content consists of forms, figures, diagrams, observations, and the like.

Time management. A clinical trial is typically conducted in several countries in parallel, which means that the data from all these trials ends up for translation at nearly the same time. What’s more, all of it has to be translated on priority and delivered to the R&D department at the company headquarters for them to analyze the results. The schedule is obviously very tight. So, the translation process needs to be one that has already been validated in terms of efficiency, quality of output, and speed.

Quality of the content. Patient data forms a big part of clinical trials. These forms are still often filled in by hand. They are then scanned and sent for recording and translation. The quality of these scans is often poor and the text is hardly legible. Yet, the translation must be error-free. Apart from this, the same form layout must be retained in the translation.

How to get clinical trial translation right

Working with a multilingual communications agency experienced in clinical trial translation is critical to assuring a smooth and efficient process. This is the only way you can be assured of quality, timely delivery, and the integrity of the translation. The agency will provide you with translators and reviewers who have experience in clinical trial translation. You can also fall back on its processes of quality assurance which have been arrived at painstakingly over time.

We list below three things that are important in getting clinical translation right. Your translation partner will take care of all of this, but a clear understanding of what’s involved is important for the client, too.

1. High-quality desktop publishing (DTP) makes a huge difference in clinical trial translation. There is no scope for errors in the document formatting, as it can lead to huge errors in data if the data in one field skips to the next field or something similar happens. The DTP professional needs to be conversant with the layout requirements of clinical trial reporting for different countries. The tools used, too, must be able to handle different document formats and possess multilingual capabilities. For languages with right-to-left or vertical orientations, the translation must be accurate as well as all the elements on the document must be placed appropriately.

2. Terminology needs to be localized for a good understanding of the requirements of a clinical trial. Remember that people can use different words to mean the same thing even when they are speaking the same language. This is because there are always variations in how people use the same language. It happens a lot with languages such as English, Spanish, French, or Arabic that are spoken in many countries in different social and linguistic contexts.

When translating from one language to another, it’s very important to use the right term in the target language. The intended audience, in this case, are people signing up for the trial must be able to relate to the term in the intended sense.

3. The use of computer-aided translation (CAT) software is important for four reasons:
(a) The CAT tool breaks up sentences into strings. This makes translation go faster and easier.
(b) the translated string is saved with the source string. This makes it easier to refer back to in the future.
(c) The translated strings are saved in a database called the translation memory. When the same sentence turns up for translation in the future, the tool will automatically show the previously translated sentence to the translator. The translator can simply go on to translate new text, thus saving precious time and money. There is also the added advantage of maintaining quality, which saves time on reviews as well.
(d) CAT tools also include a termbase, where all approved terms are saved. Translators can refer to it to understand how to use different terms, which ones should not be translated, and more.

Of course, remember that the tools are only as good as how you use them. So, the multilingual communication company must be adept at these tools and use them effectively.

Translation is a complex process and translation of clinical trial data, even more so. But when you work with the experts, you get to focus on your core tasks and not have to worry about the nitty-gritty.

Choose your translation partner wisely: translators will prove to be just as important as the researchers and medical professionals you work with. Errors in translation can cost a lot to correct, apart from the serious consequences it might cause.

Best practices for e-learning localization

1. Localization needs to keep up with the course development. That way, localization takes the least amount of time, effort, and money. If localization is only added as an afterthought, at the very least it can take more time to complete. At worst, you might even have to re-do parts or all of the program. For instance, if you have used a theme in your e-learning course and woven the entire course using that theme. If this theme makes no sense in the target market, you’d then have to re-do the entire program.

2. Get inputs from stakeholders. Identify your audience and understand their learning needs. What format would they prefer the learning modules to be in? On what skills would they like to be trained? How about the length of the course? Which language would they prefer the training to be in? On which device would they take the course? It’s best to get their inputs when beginning to develop the course, so as to ensure maximum engagement.

3. Determine your translation approach. Translation can be done in three different ways: entirely by a machine, by humans, or with a hybrid approach where humans
work with machine output and improve it. Usually, for e-learning, it’s either completely translated by professional translators or a hybrid approach is adopted. A pure machine translation (MT) approach may not be suitable and is not recommended.

4. Select your translation technology tools. The translation tech landscape is nowadays very diverse and complex. Choose the tools that would work best with the learning management systems (LMS) that you might be using. See next section for more details.

5. Work with an experienced and knowledgeable language services agency. The agency must be available to provide all the services required for e-learning localization, and not just translation. E-learning might take many forms, including virtual conferences. Here, additional services such as automated transcription and voice over would be required. The agency must be able to handle the services that are required for media localization, work with efficient tools, and provide round-the-clock project management.

Tools to use for efficient localization

LMSes have now evolved to adapt to localization requirements. Here we mention some of the widely used tools in the industry.

Articulate StoryLine: With this tool, you can create one course with multiple languages. One way it does this is the branching method where the learner is asked for their language preference at the start of the course. The other method is to use layers so that you can offer different languages in a single StoryLine file. StoryLine can be very efficiently used to translate PPTs, edit audio, and hold multilingual virtual training sessions.

Crossknowledge Mohive: It’s an e-learning authoring tool that features multi-language translation through XLIFF exports and imports. The translators are able to see the context of the words, thus enabling more accurate and faster translation.

Other tools that are great with learning content localization are Adobe Captivate and Trivantis Lectora, to name just a few.

Several translation technology solutions are either built into these tools or need to be plugged in. Some solutions are important to control budget, increase speed, and maintain quality.

Translation memory: This is a tool that saves all previously translated sentences (strings) in a database. As new content comes up for translation, this tool instantly recognizes words, phrases, or sentences that may have already been translated and approved. It populates them on the screen, so that the translator doesn’t need to translate them again.

Terminology management: You might have terms that are unique to your organization in your training content. Or maybe terms that are used uniquely and hence the meaning must be retained as such in the translated content. Perhaps you do not want to translate brand names. You might have to add new terms as your company launches new products or retire some terms when they are no longer relevant. All of this and more can be done through terminology management tools. However, a trained linguist must maintain the term database.

Project management capabilities: The LMS must be able to support several professionals working on the file simultaneously. The project manager must be able to assign different parts of the project to voice artists, translators, proofreaders, reviewers, video editors, graphic artists, image editors, developers, and so on. The project manager must also be able to easily see the progress, flag delays, and interact freely with anyone working on the file.

Gurdeep’s Bhangra

Bhangra is a folk dance from the state of Punjab spread across the countries of India and Pakistan. Punjabi-Sikh farmers traditionally dance the Bhangra to celebrate the food they grow and harvest and their relationship to the land. They break into Bhangra to celebrate pretty much any major milestone in their life: marriage, childbirth, or at festivals.

You can do Bhangra quite energetically or you can set your own pace. Gurdeep leans towards the latter style, making it very accommodating, forgiving, and liberating.

Folk dances, unlike classical dances, usually have an all-encompassing nature. Everyone can step in and soon be a part of the group energy that suddenly seems to spring forth. Bhangra movements open up the body, with arms being raised high and legs kicking outward rhythmically. Gurdeep couldn’t have chosen a better happiness tool. He truly believes in the power of Bhangra. He told Christian Science Monitor, “If you’re dancing Bhangra, and you are not happy, that is not Bhangra, even if you are doing all the moves perfectly,” he says.

Gurdeep’s Yukon

Though Gurdeep has lived in many towns and cities across Canada, Yukon is the place he calls home. It wasn’t by coincidence, but a very deliberate choice he made after touring the country, as Yukon reminded him the most of his village in Punjab.

He has now claimed the status of being the most famous person from Yukon on social media. He has taken Bhangra to Yukon schools and danced in its wildernesses, hardly seeming to notice that it’s freezing outside.

Gurdeep’s translation

When one watches Gurdeep on the snow-smoothened landscapes of Yukon and you hear the drums beating in the background, in a way it feels like translation. Gurdeep uses dance to speak to anyone, irrespective of their language. Dance is the way he translates the spirit of rustic Punjab into a universally accessible and intelligible language.

Like a translator, Gurdeep is bridging cultures. But unlike a translator, his work is easier in a way as he does not have to deal with words. We have all enjoyed the fruits of translation at some point or the other in life, but we seldom stop to think about what translation involves. It might seem to be merely converting the words from one language into another. It might not seem like a creative work of art. But that’s what it usually is, even when you might be translating commercial content.

For, a translator stands not just between two languages, but two universes. Firstly, their own right understanding of the original is critical. And then, they must navigate through to the target language and find the right words that will accurately convey the sense of the author. Not always easy. Never a mere mechanical action of interchanging word from one language to another.

While Gurdeep might not have to contend with the world of words, he doesn’t shy away from challenges. Going out into the freezing climes of rugged Yukon and dancing Bhangra everyday during the pandemic… just to spread a little cheer in the world – it does take a heart full of courage and love to do that.

Gurdeep says that when one starts dancing, all the differences melt away. “We create differences that don’t actually exist and the more we start thinking about these differences the more we confirm that they exist,” he says. “Instead we need to find the goodness in people. And that’s what I’m doing through my dance work.”

More power to you and all those who dance with you – from the Lexcelera family. Merry Christmas!

Vijayalaxmi Hegde

Localization of all aspects of the course

Localization includes translation of the text, audio, video, and adaptation of the entire course content to the target locale.

Audio and video content need to be transcribed and then either subtitled or dubbed. Voice over is also an option for translating media content. Tools are available to automate the process of transcription, subbing, and dubbing. However, a layer of professional editing will be required to make sure no errors have crept in and quality is maintained.

Next, the entire course content has to be localized for the learner’s locale. This refers to adapting even the smallest details such as name and address format, script orientation, visual elements, and so on, to the locale. Such attention to detail will go a long way in creating a very authentic experience for the learner.

Language-led immersive learning is the way ahead

Keeping the learner engaged is a real issue. The use of Augmented Reality (AR) and Virtual Reality (VR) tools will increase to make the learning experience very real and relatable for the learner.

Gamification too will see more maturing with learners demanding a more vivid and game-like feel.

However, imagine this: you have created an immersive experience using these tools. If the interface is not translated and the learner needs to interact in a language that is not his/her mother tongue, it can hardly be called an immersive experience.

So, language is the beginning of an immersive experience. Of course, you need much more to truly create immersion, but if you don’t start with language, you’re on shaky ground.

Greater use and integration of language tools with learning management systems

The language and translation technology landscape is rapidly evolving. With the power of artificial intelligence (AI), these tools make the translator’s work go much faster and easier. As these tools have the capability of continually learning on their own, the quality keeps improving, resulting in a much better training program.

Learning management systems (LMS) and language and translation solutions will get integrated more closely going forward. This will enable seamless translation as well as translation into many more languages.

Global content partners take centrestage

Localization delivers the best results when it is integrated with content creation. For this to happen, global content providers must become your partners. This enables them to advise you on avoiding pitfalls in content creation that can take much effort and time to correct later on. For instance, if you embed text in images or videos, it can remain in the source language even in translated versions. This will create a jarring effect. And, correcting this can take a lot of effort, as it will have to be done in image or video editing tools for each language you’re translating into.

Making it more accessible to translators

Micro content formats are popular in training modules. These typically have shorter sentences. This lends itself to easier translation as the translator can easily view and translate them on their mobile apps. This too contributes to their productivity as they can simply translate even when they are commuting or are outdoors.

Translation will be needed in more language combinations

E-learning has become hugely popular in all corners of the world since the pandemic. This will bring people speaking many different languages to online education.

That means, more translators from these languages and with experience translating e-learning content will be needed. It might bring up the challenge of additional and trained resources. However, we expect that given the demand for such e-learning translation, the challenge would only prove to be teething trouble.

How we performed

An Overview:

• All of our clients felt it was easy to very easy to work with us.
• We handle more than 50% of most of our clients’ translation needs – for some, it is 100%.
• At least 96% of our clients would certainly recommend us to their peers.

We asked our clients about the priority they accord to some criteria and the satisfaction level they feel on these same criteria from Lexcelera’s deliverables.

The full results are represented in the diagram below. The blue line represents clients’ expectations while the chrome line represents clients’ satisfaction levels on the criteria. We will comment on only 2 criteria: Circled in green is one area where we are over-delivering, and the light yellow shows an area for improvement which could have beneficial knock-on effects elsewhere.

Our customers would like us to understand their expectations better, including non-verbalised ones. “Why do you want to translate, what is your goal, who is your audience, how important is this content to your end customer, why such a short timeline?” are some of our numerous queries. But we probably limit ourselves from asking too many too often.

As part of our continuous improvement, we are committed to communicating more with our clients, offering quick e-appointments to validate our understanding of the project scope.

Some of our clients work with their own tools and have well-established processes which serve their business requirements well. They mentioned that we have been able to integrate easily with their tools and processes. This is directly in line with Lexcelera’s motto “We make global easy”.

Additional services our clients require from us

Lexcelera has long grown from being only a translation agency to a company that partners enterprises in their journey to global markets. In this process, we are able to provide turnkey services to our clients to take their content from local to global (or multi-local). However, not all our clients are aware of the full range of our services.

That’s why we asked them what other services they’d like to get from us. We already offer all of the services that they mentioned (listed below). So if you’re our client and reading this, feel free to contact us right away about any service below:

Hotline for short and strategic translations. About 30% of the clients mentioned this as a service they would like to obtain from us. It shows the changing nature of content and, hence, translation. Content additions are not always made in huge volumes. Sometimes, it’s just a marketing tagline that needs to be translated. However, it may be required in 15 languages, and it must reflect the spirit of the original. Hence, though it might look like a small translation job, it’s very strategic.

It also applies to strategic communication via mail to the management or to international clients. In this case, clients are mostly looking to have the translations proofread and reviewed by us. We offer this service 24/7.

Content creation services in any language. As content becomes the mainstay of marketing for companies the world over, we have been seeing increasing demand from clients for multilingual content creation. Our team of journalists, native-speaker editors, and graphic designers are always on call to help out clients with their emerging content needs.

Our project managers are keenly aware of the different types of content you might require and can guide you on what might work best for you. Our editors are not only expert linguists but also have their specialized areas of expertise.

Writing for the web is also our forte. The content we produce is optimized for search engines, so your customers can find you quickly.

Real-time machine translation. This was the next high-demand service with good reason. Machine translation is the way to go in the global content journey. Some content types generate a lot of volume and cannot be feasibly translated by humans. Nor is it even required. Speed and cost are more important than quality in content types such as social media, user help, legal discovery, and other repetitive content types. Social media translation is needed quickly and in huge volumes for our clients to gather competitive intelligence.

Clients can take advantage of instantaneous translation via the LexTranslator, a customized real-time translation widget. It is available in 50 languages for online content of various types including website content, online help, chat, and community forums.

Access to LexPortal for real-time tracking of projects. Our fully cloud-based portal lets clients keep a tab on the many projects that they run with us, with just a few clicks. It’s centralized and has intuitive navigation which makes it easy to use.

Access to LexMyWords, online glossaries Widget. LexMyWords is the online terminology management application created and owned by Lexcelera. It helps clients to search our database for an industry-specific term. The data is confidential and is password-protected. A fully revamped version of the widget will be released in the coming months.

Terminology databases and glossaries are immensely useful in storing definitions of terms. It not only saves the translator’s time, but also makes sure that the term is consistently understood by all the readers. As new terms are added or old ones deleted from the product literature, the changes are reflected in the glossary, keeping everyone up-to-date.

We encourage clients to tap into our full repertoire of services so that they get the convenience of availing all multilingual content-related services under one roof. It brings about greater continuity and consistency in quality. It also gives us a better opportunity to understand your business offering and accordingly work with you to make your international marketing a success.

The pandemic impact on mining regulations

The Coronavirus pandemic impacted the mining sector severely, as it did so many others. S&P Global identified 275 disrupted mining operations throughout the world in June 2020. When the lockdown ceased and mining operations resumed, the industry had to contend with new regulations on safety and travel.

Companies had to be on their toes to communicate pandemic-related guidelines to their staff working at different sites. The guidelines would change from time to time as the pandemic went into the second year and beyond and it would be vastly different across locales.

It was at such times that a company’s communication processes came to be tested. Companies that had a communication team in place or strong communication processes could quickly tide over the pandemic challenge by keeping information flowing smoothly. It also meant that they needed to translate the content because of the global nature of a mining company’s operations. Not having information in one’s language can cause confusion and anxiety in times of uncertainty.

Regulations for safety and environmental protection

Mining companies need to put in place a host of safety protocols to protect their staff, machinery, and the local population from accidents and disasters. It also helps to safeguard natural resources from pollution. For instance, there are regulations for the storage of mine tailings. Leaks or breaches in mine tailings dams have been known to cause huge disasters to the environment as well as loss of human life.

Hence, countries have brought in laws on exploration activities of mines. Often, different states, counties, or regions in the country can have specific laws applicable. They need to be complied with in addition to any national and international laws.

Various permits are required from the government for a mining company to run its operations. Elaborate documentation needs to be done on the various compliance measures that a company has undertaken to secure these permits. They may often need to be created in the local language; but they will also need to be translated so that headquarters can validate the documentation. Translation enables the legal department to be closely involved in the documentation process.

New and upcoming regulatory changes

The mining sector has had to continually adapt to changes in the regulations governing it. Below, we talk about some important developments in regulation around the world.

Canada amended its Metal and Diamond Mining Effluent Regulations in June 2021. It relates to the effluent discharged from both new and existing metal and diamond mines. Effluent concentration limits for zinc, nickel and copper are unchanged, but mining companies need to note the changes in the arsenic, cyanide, and lead concentrations, as well as for un-ionized ammonia.

A couple of years ago, Canada replaced the Canadian Environmental Assessment Act with the Impact Assessment Act (IAA). One of the key objectives of this Act is to bring in more transparency in the decision-making processes of the Impact Assessment Agency of Canada.

The International Seabed Authority (ISA) is currently working on draft regulations for mining the ocean bed. The Pacific state of Nauru has proposed a deadline of mid-2023 to come up with the regulations, but some other countries from Africa and Latin America have said that this deadline may be missed. This delay might hinder companies seeking to start their ocean mining operations.

The European Union announced earlier this year that it would bring about new rules for mining raw materials. The details of these rules are not known as yet.

The role of content in compliance

Effective content creation for compliance leads to transparency and a better image of the company. The mining industry is frequently seen as a polluting industry unlike perhaps a sector like IT, which, of course, owes its existence partly to the mining industry.

Mining’s image affects it in many ways, including making it difficult to find great talent. Hence, mining companies have begun to clean up their image by way of their environmental, social, and governance (ESG) efforts. And content is needed to proactively communicate about these efforts to the local community, authorities, employees, and investors. Putting this social data out there is critical to a mining company’s future strategies.

Content production for a global mining company must include translation and localization. Local government authorities may expect you to fill out forms and submit documentation in the local language. Intra-company communication as well as guidelines need to be available at all the branch offices in the local language.

Instructions and information about best practices around ESG must flow from headquarters to the local site offices. Headquarters must, in turn, be kept in the loop about the compliance steps taken locally.

Thus, a mining company creates a lot of documentation – both for external as well as for internal use. It is created in formats prescribed locally and with local terminology when a local law has to be followed. When national or international laws come into consideration, the format and terminology may vary.

Many versions of the documentation need to be created in all the languages of the countries the company operates in.

It all ends up in humongous volumes of content, which is also complicated. Hence, it’s best to work with a global content partner so you can navigate around the content creation process without hiccups. Lexcelera has been working with mining companies around the world and is well-versed with content creation for this sector. Get in touch with us today to know more on how we can help you.

What is ESG and why it’s important to the mining sector

While mining is important for our energy and industrial needs, it is vital that mining companies become ESG-compliant so that we can bring about a low-carbon economy. This safeguards our existing natural resources such as forests, rivers, and the local flora and fauna. It is necessary to bring down emissions so that we don’t aggravate the problem of global warming and climate change. Also, the environmental goals of the company need to take care of the waste or tailings produced as a result of mining activity.

Indigenous populations often get affected by mining activities. They naturally are concerned about the steps a mining company is taking to mitigate its impact on the local environment and economy. The social goals need to address these concerns, the working conditions, and the health and safety of the local population.

The governance goals include steps taken to ensure that the company has systems in place for compliance, ethics, transparency, and anti-bribery practices.

The impact of mining has resulted in investors becoming sensitized to the need of producing sustainable raw materials. For all these reasons and more, a mining company needs to set ESG goals for itself and strive to reach them.

How creating the right content can help the mining sector

Mining companies creates huge volumes of data consisting of reports, etc. that record the processes and tasks completed towards reaching the ESG goals. This data needs to reach the intended audience, so that a mining company can operate smoothly on the ground by winning the local people’s confidence. It also helps in keeping investors accurately informed about the company’s ESG efforts.

Who then is the intended audience?

1. The local population. The local people have a direct interest in the workings of a mining company in their neighborhood. Communication to them on ESG efforts has to be clear, translated or created in the local language, and presented in easy-to-use formats.

2.The local government authorities. It’s important that the local authorities stay informed about your company’s work to comply with any local environmental regulations. The documentation must be created in the way that is accepted locally and in the local language.

3. Investors. The efforts put in by your company to reduce its carbon footprint must be well documented and presented to the investors. If communication fails on this front, investors are not informed and much of the sustainability efforts are lost. Again, the documentation created at the on-site offices must be translated into a language that the investors primarily speak.

4. Employees. Internal communication is vital on the company’s processes to mitigate the environmental, social, and cultural impact of mining. Only well-informed employees can understand the processes and help to contribute in their effective execution. Also, keep in mind that a mining company’s employees are dispersed throughout the world. It is important for the local employees to know about ESG efforts in their locale, while headquarters employees will need to keep a tab on ESG efforts in different places where the company is operating. This helps them report to their managers and provide them with comprehensive, accurate information. Thus, the flow of information is unimpeded and fast.

Multilingual communication is necessary to a mining company because of its global nature. Their offices are spread on all continents. It results in a multitude of languages being spoken within the company.

It also means that there are many ways of communicating according to the socio-cultural background of the communicator. Establishing best practices and guidelines on communication will help in the clear and smooth flow of information, minimize risk, and increase productivity and compliance.

Working with Lexcelera to create effective content

Lexcelera is a Paris-based global content creation and translation company with offices in London, Bangkok, Buenos Aires and Vancouver that helps enterprises to communicate effectively. We understand the strategic role of content to the operations of a mining company.

Our domain knowledge of mining content that comes from long years of working with mining companies around the world helps us create content or translate with the right terminology and tone. Often, the terms that are used in one locale might not work in another. Direct translations will not work in such cases and you have to be conversant with the terminology relevant to the region. The tone of voice to be used in the content goes a long way in creating successful content. And, because there are different types of audiences involved here, the tone needs to be accordingly modified.

When you work with Lexcelera, you are able to avail of our services in many languages under one roof. We work with African, European, South American, and Asian languages. Instead of sourcing each language from a particular vendor, you can work with us and have all your content created and translated for multiple languages from one partner.

Our linguists and content writers are subject matter experts and can produce content that is aligned with your goals of communicating about your ESG efforts clearly to the intended audience.

The content often consists of key performance indicators (KPIs) set to help a mining company achieve its ESG goals and details of the actions taken on the ground. This can run into thousands of pages of data containing text, visuals, charts, and more. All of this needs to be digested, condensed, and reproduced in a way that the stakeholders can easily access the information they are looking for and understand it.

ESG goals and creating effective communication around it are vital to a mining company’s present and future success. Not only are people all over the world more sensitive today to the socio-environmental outcomes of mining, but resources are also depleting. All of this has resulted in a very competitive sector where first movers get the advantage.

Take the opportunity today to speak to Lexcelera about how you can create and translate content that highlights your success with ESG goals.

Why translate internal communication?

Given the global nature of their work, the staff of mining companies speak different languages. For the smooth conduct of business, clear and effective intra-company communication is essential. Only then can all the employees work together towards their common goals.

Some companies may think that having one language across the company is sufficient. And, usually, this is English. The people at headquarters may expect employees at other locales to speak English, irrespective of their native tongues.

This can lead to misunderstandings, as the English proficiency of overseas employees may vary. Such misunderstandings may cause errors, which may turn out to be grave sometimes. They may lead to accidents at worst and inefficiencies at best. They may also lead to feelings of alienation among the employees and contribute to labor strife.

In some locales, it may be required by law that the communication with local employees be in the local language. This helps in better outcomes for training programs, better understanding of compliance requirements and safety regulations.

In mining companies, safety is a priority, and hence in-language communication must be followed.

What needs to be translated internally?

Critical information: Every employee needs to be aware of the company’s goals, so they can work towards these goals. This is important not only for the realization of overall business goals, but also for the individual performance requirements of the employee. Select the language or languages most commonly spoken by your employees and translate this information into those languages first.

Company/Sector jargon: Every sector has terminology that is specific to it. And, then a company might have its own set of terms or jargon to refer to its products and processes. Translating them is important so that you are sure that the terms are understood accurately, without any room for misunderstanding.

Company newsletters: Keeping employees informed of the goings-on in the company is a good way to keep them engaged. They can participate in company events, assimilate company values, and collaborate better.

Training material: When you train staff in their languages, they are able to learn and understand better. They can adhere to the company’s internal processes better. This leads to a coherence in the working of the company across all departments and locales. In some countries, it might even be required by law that the employees be trained in the local language.

Communication between the employees: This can be in the form of mails, memos, and the like. These are typically more urgent. They may not be voluminous all the time, but accurate understanding of the message is required.

Processes for translation of internal communication

Reaching any goal in a multinational company involves translation. Here are some guidelines to follow to achieve efficient translation.

Localize and translate for each locale. Company documents must be localized and translated to suit every location where the company is operating from. This ensures accurate understanding of the information by all employees. They can and should give feedback on the quality of translations and suggest documents for which they need translations. Translations must be coordinated centrally so that quality consistency can be maintained.

Collect data on languages for translation. Don’t assume the languages of choice of your employees. Ask them which languages they would prefer to have the translations in. You can always prioritize and translate in batches, if you can’t accommodate all the languages at once.

Work with an experienced translation partner. Internal document translation requires constant collaboration with a translation company. It must not only be a veteran translation company, but must also have significant experience in the mining domain. They can advise you on the different processes to be followed for different types of content. For instance, you might need a machine translation (MT) solution for translating emails on the fly. For longer documents related to training or safety regulations, for instance, may need to go through a more conventional process of translation, editing, and proofreading.

Mining companies create a lot of documentation and a significant part of this is for internal consumption. Translating internal documents makes for effective communication when the sender and receiver speak different languages. It leaves no room for error and miscommunications. Most importantly, it makes both parties feel included. Neither party is forced to speak another language in which their fluency might not be the same as in their native language.

Partner with Lexcelera today for accurate and fast translation for efficient communication within your company.

1. Assess privacy

Ensure sensitive content is not compromised during translation. Some open source tools can send data to third-party servers for processing. It is therefore preferable to choose solutions that guarantee confidentiality. Either by internalizing the solution to your organization or by subscribing to SaaS with your translation partner.

2. Protect data

If you need to translate sensitive content, consider additional protection measures, such as encrypting data before translation or using local servers to limit unauthorized access. If you don’t like either of these suggestions, you’ll need to “anonymize” the data intended for translation so as to protect it.

3. Check quality

NMT can provide translations of varying quality, depending on the technicality of the document, or its language level. Define specific quality criteria to evaluate machine translations. You can measure such things as accuracy, terminology consistency, and linguistic fluency. If any of these criteria are not met, it is recommended that your content be proofread by a mother tongue linguist.

4. Human revision

For sensitive, strategic or legal content, consider human revision to ensure accurate translations. Human, mother tongue reviewers can detect and correct errors that may have a significant impact on the meaning and intent of your content.

5. NMT Engine Training

You may want to consider training customized engines with your own sensitive data to improve translation accuracy. However, be sure to comply with data protection regulations and not disclose confidential information. So, here again, it is preferable to use a company specific solution or an SaaS solution via a professional. The latter will know how to ensure the security of your data, while providing you with training and maintaining your customized translation engines.

6. Awareness of cultural adaptation

Machine translations can be influenced by cultural or linguistic bias, contained in the corpus used in its training. An analysis of the training corpus by a computational linguist is therefore advisable. It will allow you to highlight possible biases or inconsistencies, but also to anonymize your corpus if necessary. The other way to counteract bias and inconsistency is to have a linguist check the machine’s output to ensure a proper and respectful translation.

7. Test and iterate

Perform regular testing to assess the quality of machine translations. If you find recurring problems or specific errors, make the necessary adjustments, whether by adding new sentences to the corpus, adding business terminology, etc. Here again, the computational linguists or terminologists of your language services partner will be valuable to you.

It is important to note that even with all these precautions, machine translation can have limitations and risks when it comes to sensitive content. Assessing your organization’s specific needs and making informed decisions are critical to protecting confidential information and ensuring translation quality.

Challenges in creating specialized technical documentation

Clarity: Content needs to be written in clear, precise language. To enable this, the terms used in the content must themselves be clear and precise. If not, the reader can struggle to understand the meaning.

Accuracy: Information documentation in fields such as medicine and industry needs to be accurate to avoid injury and ensure the safety of people and property. There is often no room for error, hence necessitating a terminology database which accurately documents the meaning of a particular term and how it can be used.

Consistency: Terminology needs to be used in a consistent manner across several versions by a team of technical writers. If the term conveys different meanings to different departments in the company, that too must be specified in the database.
Over time, the same term may take on more meanings, discard old ones, or change its original references. Terminology management needs to reflect this evolution in the term use.

Version control: Technical documents are continuously updated with each new feature release or product update. Efficient version control is necessary, so that it is easier to roll back document updates when necessary or refer to previous versions.

Collaboration: Usually, a team of technical writers work together but asynchronously on the documentation. It requires that cloud-based platforms are necessary for the team to collaborate seamlessly.

The Domino effect: inadequate technical documentation leads to unreliable translation

If the original content is ridden with errors, inconsistent with style, and is not easily understandable, it can impact the translation. The translated versions will carry forward these same errors and make it a much more difficult and expensive process to fix the errors later on.

Lack of consistency: It can be confusing to translators when a term is used varyingly in the content. They may then end up using the term in erroneous or outdated ways. It may not be in agreement with the company style and may convey a different meaning. A central, managed repository of terminology which provides a constant reference for the terms can take care of this issue. It can guide the technical team in using the term consistently in the source content.

Lack of clarity and accuracy: If the correct terms are not used in the source content to describe the product or service, the translators will also make the same mistakes in multiple languages. It will then cause issues to the customers when they use the product or service. It can cause injury or inconvenience to the user and may result in important information getting lost, misinterpreted, or omitted.

Lack of context: Without context, translators are working blind. They have no idea of understanding how a particular word would be used in the document. A well-defined terminology database sets the right context for each term and makes translation go easier and quicker.

Delay in translation: All of the above issues result in slowing down the translation process. Back-and-forth ensues between the translators, project managers, clients, and other collaborators. The same issues may come up again and again, causing deadlines to be missed and product launch schedules to go awry.

Mounting costs: The cost of translation can exceed the estimated budget with the many errors, delays, and revisions.

Messed up user experience: Help guides produced in this manner do not help the user, but may often leave them confused. It may not provide the answers they seek, instead it may cause accidents, too, in the worst case scenario. Needless to say, users are disgruntled and the reputation of the company is lost. They may discontinue the use of the product or service. They may also leave negative feedback on social media, causing further disrepute.

Possibility of legal disputes: If the user suffers losses or injuries because of errors in the technical documentation, it may lead to lawsuits. This can cause losses to the tunes of millions to the company.

It should be obvious from reading the above that high-quality terminology management needs to be introduced at the time of source content creation to take care of all the issues that may crop up later. In our next post, we will talk about terminology management, consistency, and whose responsibility it is to develop the terminology.

Domain experts

Product engineers or product development engineers have actually been involved in the design of the product and taken it through the several iterations of development. They are the best placed to explain the specialized technical terms that the product literature may include.

Subject matter experts or specialized consultants have in-depth knowledge of the field. Their input is necessary to set the context and use the right terminology according to industry standards. They may be part of internal teams or hired on project basis.

Technical writers will create the original documentation, working in tandem with product engineers and specialized consultants. They have the professional skills to effectively communicate the usage guidelines, safety precautions, do’s and don’ts and so on about the product.

Translation and localization service providers

Some translation agencies specialize in technical translation. They have teams of technical translators and terminologists who can help create consistent terminology for technical documents.

Their experience and skillsets help them understand the terms in the original documentation clearly and build a central repository of the terminology, which clearly defines each term. This terminology database is accessible to all translators working on the translations into their languages, so that they have a correct understanding of the term as set out in the original document. This helps in clearing up any confusion on the intended meaning of the term and they are able to come up with the equivalent term in their language.

These translation agencies also work with terminology management software which enables consistency and standard use of terminology in all documentation produced within the company. However, an in-depth understanding of terminology management practices is required to use the tools at their optimum.

Standardization and industry organizations

Standardization organizations issue standardized terms and norms for various industries. This saves companies from having to re-create terminology from the scratch all the time or using terminology erroneously. Also, as the standards apply across the industry, it is easier for customers to comprehend the products and services and compare them between companies. Standards also allow for thinking on how to evolve terminology creation processes and involve all stakeholders in the process.

Industry associations in some sectors may possess terminology resources curated over time, which can be helpful in providing terms specific to that sector.

Often, all or a combination of these teams may need to work together to come up with terminology management processes, tools, and best practices. It is important that there be cohesion and collaboration among the groups to produce technical guides useful to the customer.

When the different teams come together, it opens new avenues of communication as they look at the product or service from new angles. It can throw light on new information on how the end-user will interact with the product, various global or cultural perspectives to be considered, and so on.

However, it is also important that the collaboration between the internal and external teams happens smoothly to produce the best results. To ensure this, clearly define roles and responsibilities of each team, stating who is responsible for which task and the associated deadlines. Within the technical writing team, create a clear management structure involving project managers, technical writers, editors, and proofreaders.

Given that terminology development and maintenance is a complex and ongoing task involving several teams, how do you decide on who does what? Some companies prefer to manage terminology all by themselves while others want to outsource the task. There can be hybrid arrangements as well. Which is the right choice? We’ll talk about it in our next post.

In-house team: Advantages

Intimate knowledge of the product: The internal team is closely aware of the product, as they are usually associated with it from the design stage. Domain experts are also part of this team and have in-depth knowledge of industry-specific terminology.

The in-house team understands very well the different use cases of the product in the real world. They can easily come up with terms that the users will relate to when using the product.

They are in-sync with the product development cycles. Hence, they are able to directly access the latest product information. This makes things go faster at the technical content production stage. Also, their documentation style and practices are already consistent with the company’s. Hence, there is consistency in the voice and terminology of the technical literature.

Easier collaboration with other internal teams: The in-house terminology team can easily collaborate with the authors and editors of the technical content, and even the product development team, if need be. This leads to less time lost in back-and-forths between these teams and faster turnaround of help guides.

Ownership: The internal team has a distinct sense of ownership. They are answerable to their colleagues and higher-ups in the company and hence, they tend to take a stronger interest in maintaining quality.

In-house team: Disadvantages

Lack of perspective: The internal team is too close to the product. They may lose perspective on how the product is seen from an external user’s point of view. They may use very involved language or very company-specific terminology that laypersons may not understand.

May not be available: The internal terminology team may have other core tasks to take care of, too. They may have limited time to manage terminology, as this is one of the many things they are tasked with. It results in delays in updating the database which, in turn, can lead to errors down the production line.

Lack of linguistic skills: The internal team may have the domain expertise of the product, but this doesn’t necessarily mean they have the linguistic or translation skills required. This may lead to terminology choices that don’t translate well or aren’t understandable in other languages.

May resist change: The in-house team may become attached to the practices or tools they have been using and resist any change in the process or software. It may even become difficult to introduce new terminology or writing conventions.

Translation agencies: Advantages

Professional expertise. Translators with specialization in technical content also have the linguistic expertise in the source and target languages. This ensures that the right technical terms are used in the target languages.

These agencies often employ terminologists who are trained to create and maintain specialized terminology for a particular field. Technical experts are also available to review the translations for accuracy and consistency.

Dedicated to terminology management. Unlike internal staff who have to manage a hundred other things as well, the translation agency can dedicate its resources to terminology management – that’s their job. This guarantees top-quality and consistent management of terminology.

Tight turnarounds can be managed. Translation agencies typically work with tight deadlines. They can handle large, complex projects because of their wide network of translators and terminologists. This helps in scaling up projects easily for global product launches.

Confidentiality. Specialized translation companies work with clients that have strict requirements of privacy and confidentiality. The translation companies are capable of implementing security measures to protect sensitive data.

Use of professional tools. Translation agencies use translation memory and terminology management tools to make sure that the phrases and terms are used in the same way throughout the client’s documentation. These tools bring in cost savings and boost productivity as they can quickly identify similar phrases and terms and show them up as suggestions.

Translation agencies: Disadvantages

Dependence on third parties. Terminology databases play a critical role in the technical content of a company. If the translation company is not dependable or efficient, then it can create problems with turnaround as well as quality control.

Change management. Changes to terminology or documentation may be more difficult to convey and execute when working with external providers.

It is clear from this post that each company has to review all of the above pros and cons of the two choices and make their decision based on their particular context and requirements. It may even be that the best of both options needs to be combined for an appropriate hybrid model. A partnership between the internal as well as the external teams often results in optimum quality, quicker turnaround, professional terminology maintenance, and significant cost savings.

Key components

There are five key components of an audit, if it is to be efficient and maintain its integrity. They are:

1. Independence and objectivity. Auditors must not have any conflict of interest with the organization or installation they are inspecting. Their independence will guarantee that the audit will be impartial and reliable.

2. Competence and expertise. The audit teams must be comprised of professionals who are highly experienced in the nuclear industry. They must have a thorough knowledge of regulations, safety standards, and best practices.

3. Access to information. The auditors must have complete and transparent access to all relevant information, including documents, operating data, and site installations. Only then will they be able to accurately evaluate compliance of safety standards.

4. Clear communication. The auditors and the organization staff must be able to have an open dialogue. It is vital for discussing the audit’s findings and be conducive to mutual understanding and problem resolution.

5. Tracking and implementation of recommendations. The audited organization must draft and implement an action plan to solve the problems identified. A follow-up is necessary to ensure that the recommendations have actually been carried out.

These components ensure that the audits are rigorous and help to enhance nuclear safety. They serve to maintain public confidence in the nuclear industry by ensuring that high standards of safety are being followed at all times.

Role of interpreting services

Often, the auditors and the organization staff do not speak the same language as they may hail from different countries. They can choose to speak in a common language, which is usually English. However, if both parties do not have enough fluency in the common language, the next option is to call in professional interpreters. Here’s how interpreters can assure the success of a nuclear industry audit:

Ensure clear understanding. Interpreters can help the auditors and the staff understand each other by relaying the communication from the other person in their own language. This brings about correct understanding and results in an accurate and transparent audit, without any misunderstanding.

Interpretation in real time. The interpreters can interpret simultaneously to keep the conversation going smoothly and save time. Simultaneous interpretation is when an interpreter translates the message from the source language to the target language in real-time.

Preliminary meetings. Before the start of the audit, preliminary meetings can be arranged to discuss objectives, expectations, and procedures. A major market operator in the French nuclear industry regularly arranges such meetings. Interpreting services are used at such meetings, too, to ensure that everyone is on the same page.

Independent and objective. For successful interpreting, it is critical to hire professional interpreters and not assign a bilingual person from either side. Professional interpreters can be trusted to be independent and interpret accurately and objectively, unlike someone who may be part of the auditing team or belong to the organization. The interpreters have an in-depth knowledge of the subject matter and perfect understanding of both languages and are able to deliver error-free interpretations.

By using professional interpretation services, you will be assured of clear and effective communication during international audits that involve people speaking different languages. This, in turn, will contribute to a successful audit, leading to improved safety in the nuclear industry.

Requirements for interpreters for nuclear industry audits

Many a time, nuclear industry audits are carried out without a common language between the staff of the nuclear plant and the auditors. That’s why interpreters play an important role in making sure the communication flows between the two parties and is clear.

Look for these attributes when you wish to hire interpreters for the nuclear sector:

Proficiency in both languages. The interpreter must be highly proficient in the two languages spoken by the auditors and the staff of the nuclear plant, as there will be constant communication from one language to the other.

Knowledge of the subject matter. The interpreter hits the ground running when an audit is being carried out. There’s no room for errors, nor there is any time to look up the meanings of industry-specific terms. So, prior knowledge of the nuclear sector is essential for the interpreter to ensure quick and accurate interpretations.

Professional interpreting skills. Whether the interpreter provides simultaneous (real-time) interpretation or consecutive (interpreting after the speaker has finished speaking), they must be very good at what they do, as the audit of a nuclear installation involves high stakes.

Neutrality and confidentiality. The interpreter must remain neutral with the subject matter they are interpreting. They must remain outside the conversation and not contribute their own viewpoints. They must also maintain strict confidentiality regarding whatever they have seen and heard during the audit. As it involves public safety, the information that an interpreter is privy to must not fall in the wrong hands at any cost.

Readiness. The interpreter must prepare themselves for the audit, by reviewing any documents that are made available to them. They must familiarize themselves with the technical terms and acquire an understanding of the specific issues involved in the audit.
Ability to handle pressure. The interpreters must be able to work under pressure, because audits may involve complex technical discussions and stressful situations.

Qualifications. Each country may stipulate its own set of qualifications that a nuclear industry interpreter must possess. For example, a major operator in the French market requires RP1 authorization for any person working in a controlled area. In Belgium, security authorization must be obtained from the Belgian Federal Agency for Nuclear Control (AFC). Interpreters may be subjected to security checks and may be required to obtain specific security authorizations.

How to hire professional interpreters

It’s clear that interpreters carry a lot of responsibility and are critical to the success of a nuclear plant audit. Hiring them can be a time-consuming process, as you must run several types of checks on the interpreters.

It’s also a best practice to hire one interpreter per auditor, so that conversations can proceed smoothly and efficiently. The interpreter/auditor pairing should be maintained for the entire audit whenever possible. Note that a nuclear facility audit may involve up to 15 auditors, so an equivalent number of interpreters will be required. One of them should be appointed as the mission coordinator so that interpreters and auditors are appropriately paired.

When you need to hire an entire team of interpreters and make sure they meet all the criteria you’re looking for, it’s a safe bet to go with a translation and interpretation agency. Here’s why:

1. Selection of qualified professionals. Translation and interpretation agencies often maintain rigorous procedures for choosing and recruiting qualified interpreters. They have the resources to evaluate each candidate’s linguistic, technical, and professional skills, so you don’t have to go through a tedious vetting process.

2. Central coordination. Agencies can effectively coordinate the entire interpretation process, including the search for appropriate interpreters, scheduling, and supply of interpreting equipment.

3. Quality assurance. Agencies have processes in place to ensure a high quality of work by their interpreters.

4. Flexibility. Agencies can scale the size of the interpreting team up or down as required. They can also provide interpreters with diverse skill sets. They can provide backups in a short time if one or more interpreters is absent.

5. Safety and compliance. Agencies can ensure their staff have the necessary security clearances to work in a nuclear plant.

In the previous blog post as well as this one, we have looked at the critical role that interpreters play in a nuclear industry audit. They must be selected carefully, ideally with the support of a translation and interpretation agency. The interpreters must themselves be highly qualified and prepare for the audit to enable its success.

All these steps go a long way in ensuring the success of the audit and maintaining public safety.

It’s time to clarify which documentation the MDR applies to, the scope it covers following recent updates.

Instructions for Use (IFUs)

• IFUs for CE marked products will now have to match the stipulations of MDR. You need to check the IFUs against the new requirements, so you can fill in any gaps.
• The patient information must state clearly the purpose of the medical device, and where applicable, what the clinical benefits would be.
• For devices that will be inserted in the body, IFUs have to specify the materials used to make the device.
• If a device is meant for lay users, IFUs have to include circumstances, if any, where they must consult with their doctors before using it.
• The IFU must mention the expected life of the product and if any follow-up checks are required.

Summary of Safety and Clinical Performance (SSCP)

The SSCP is another critical document required by the MDR. It includes design verification/validation reports, the risk management report/file, the clinical evaluation report, and post-market surveillance (PMS), and post-market clinical follow-up (PMCF) plans and reports.

Content for the SSCP can be primarily derived from the IFU, where applicable. The SSCP of each device will be made publicly available on Eudamed, the European database on medical devices.

The entire Instructions for Use (IFU), along with the updated content, the Summary of Safety and Clinical Performance (SSCP), and other technical documentation as required by Annexes II and III, must be translated into all the languages of the EU countries where the product will be sold. This information needs to be accurate and written in plain language to ensure accessibility for non-medical professionals. Specialized content with medical jargon must be simplified.

Any changes made to the device or documentation in one language must be reflected in all other language versions. The Notified Body will validate the documents in one language.

For subsequent translations, the company can ensure quality in two ways:

1. The company’s regulatory affairs department or legal counsel in each country can validate the translations.
2. If there is no in-country counsel, the company can use a back translation process. This involves translating the document back into the source language and comparing

it with the original content to ensure accuracy. The translation agency performing the back translation should be different from the one that did the original translation.
A translation certificate is highly recommended to accompany the translated documentation when applying for certification.

If all required content under the MDR is not translated into the languages of the countries where the device will be sold, the device will not receive CE certification, resulting in a loss of market access. Thus, accurate translation is crucial.

Choose translation partner with care

As every improvement or change to the product or its packaging would result in cascading content, translation is a process that life sciences companies have to integrate with their business processes. It’s not a one-time event any more. It’s a constant, continuous service that you will need.

It is all the more reason to choose your language partner with care, as it can make a difference between being able to sell in Europe or not. Keep in mind the below when selecting a multilingual medtech content company:

• To begin with, your translation company must have experience in creating and managing multilingual content for medtech companies. It is highly recommended that they already have the tech infrastructure, especially terminology management and translation management tools as this will enable faster work. It must be familiar with regulatory requirements that relate to content, so that it can audit your content and advise you on gaps that need to be filled.
• This process of assessing the content gap can be time-consuming, as it has to be done for all the patient manuals of CE-marked products. Very few life sciences content companies have content management systems (CMS) to systematically identify and fill the gaps. A CMS is critical in doing this as it saves a lot of time, maintains versions, and brings transparency.
• The content company must have a solid, multi-level review process to meet the stringent requirements of MDR. This ensures that the required high levels of quality can be delivered. Clear channels of communication must be established for stakeholders, project managers, and translators. The review and feedback processes must be documented.
• It must have an established system of managing the many language versions, so that changes or updates in the future can be quickly implemented across languages.

Lexcelera has built a strong reputation over the years for its innovation in translation technologies and its extensive range of multilingual services. In February 2021, Lexcelera was acquired by the t’works Group, a specialized translation services provider, though it continues to operate independently under its own brand and management.

Lexcelera offers a comprehensive suite of language solutions tailored to meet the needs of the medical equipment industry. A pioneer in the use of cutting-edge translation technologies, Lexcelera has developed AI-based machine translation engines and other high-performance tools to enhance translation efficiency and accuracy.

In the previous blog post as well as this one, we have looked at the critical role that interpreters play in a nuclear industry audit. They must be selected carefully, ideally with the support of a translation and interpretation agency. The interpreters must themselves be highly qualified and prepare for the audit to enable its success.

All these steps go a long way in ensuring the success of the audit and maintaining public safety.