Kristen Giovanis

It started with a small wording change in the 2007 revision to the Medical Devices Directive, and now it seems next year’s fully–engaged set of electronic expectations is closer than ever. In this series on the approaching EU e-Labeling Directive, we’ve covered a bit of ground: from how the directive safeguards the end-user, to the challenges manufacturers face, to how technology may solve (or not) the challenges. But planning for the directive remains critically important. Last week, we gave the first of our strategy suggestions. This week, we give the final suggestions for creating an effective e-labeling strategy:

• Plan for long-term data revision and retention: The Regulation imposes strict revision notification and data retention obligations to keep e-labeling available for from two to 15 years (depending device and its use). Creating a strategy to manage these data revisions over this long time period, through different management regimes and across countless budget cycles, is paramount to the successful transition from paper to e-labeling.
• Watch the regulatory situation—and the competition: Since the release of the final draft Regulation, a number of companies that had been watching and waiting to take action began to execute long-planned moves. As companies roll out their strategies, the next 36 months will prove fascinating for industry observers and players.
• Be careful not to underestimate the complexity of e-labeling: The biggest e-labeling challenges rarely come from the technological sphere. Typically, any underlying business process problems must be addressed before an e-labeling project can move forward. A collaborative approach across company divisions—including service partners, technology, and regulatory groups—usually helps with developing and executing a successful plan. This collaborative approach also helps with measuring positive impacts of e-labeling on global business and markets.

Kristen Giovanis is CEO of KJI, a leading localization service provider based in the United States. Giovanis holds a Juris Doctrine with a focus in global regulatory law from William Mitchell College of Law and frequently advises life science manufacturers on global labelling and language compliance. Contact:kgiovanis@kjinternational.com. You can follow @kjintresources on Twitter.

Minneapolis, MN—May 17, 2012 KJI announced the successful completion of three rigorous recertification audits by TUV North America. The three successful audits allow status renewal of ISO 9001:2008, ISO 13485:2003 and EN 15038:2006.

“This recertification shows the seriousness with which KJI approaches translation tasks and processes,” said Janna Lundberg, Chief Operating Officer and Quality Manager at KJI. “We feel it is critically important to match the robust commitment our clients have to their processes and their customers.”

EN-15038:2006 is a quality standard published by the European Committee for Standardization that provides the most relevant certification within the translation industry. All EN-15038 certified firms must undergo regular audits that guarantee maintenance of specific high quality standards in processes and resource management.

ISO 9001:2008 is the globally recognized standard for quality management published by the International organization for Standardization. Recertification demonstrates the ability to consistently provide product that meets customer and applicable statutory and regulatory requirements. By focusing on continual improvement, KJI aims to enhance customer satisfaction through the effective application of quality processes.

ISO 13485:2003 is another globally recognized quality standard specific to manufacturers of medical devices and their critical suppliers. Recertification demonstrates effective quality systems that satisfy the additional safety, regulatory and quality concerns specific to the medical device industry—as audited by the rigors of an independent, external audit. KJI maintains this standard to effectively align KJI quality processes and risk management approach with the rigorous processes and approaches of clients in the medical device and diagnostic industries.

The KJI commitment to continual improvement helps ensure quality and consistency across all languages and domains. Recertification within these standards demonstrates the KJI commitment to ongoing quality management, resource management and operational procedures. Recertification is also an opportunity to demonstrate the ongoing investment in and commitment to the same high quality standards and processes as KJI clients.

Molly O C Rowan

The full stop indicates the end of a sentence. Even when the grammar of a particular target language requires a different internal structure or phrasing than the source material, the full stop in translation most consistently matches the source. The full stop has different forms depending on the language:

In Korean and languages that use variants of the Latin alphabet, the full stop is realized as a period, a dot on the baseline (.) and is followed by one space per ISO standards. (The convention of two spaces after a full stop is a remnant of the days of typewriters and manual typesetting and is now considered an antiquated style.) This dot character is also used in mathematics, but its function varies by language; it can serve as either a decimal separator or digit group separator.

Chinese and Japanese both use an ideographic full stop (。[m1] ), a small, empty circle instead of the solid dot. In Traditional Chinese fonts, the full stop falls on the midline, but in Simplified Chinese and Japanese fonts, the full stop sits on the baseline. This character does not require a space to follow it because the visual space is a part of the full-width form.

Because words are not separated by spaces, Thai simply uses a space to indicate the end of a sentence. Some languages that use the Devanagari script like Hindi use a vertical line (|[m2] ) to indicate a full stop.

Molly O C Rowan is a Localization & QA Specialist at KJI. She has a degree in Linguistics and loves language, books, and her dog. Contact: mrowan@kjinternational.com. You can follow @kjintresources on Twitter.

Susan Anderson

A few of us recently returned from a week-long tour where we continue to uphold our mission – to take advantage of being in the area. This time it was taking advantage of a single flick of the passport in the charming continent across the pond, thanks to NATO and the Schengen Agreement. After eleven flights, three rental cars, two trains, and one car service, our team cruised through Europe, and we visited seven countries in five business days! Using the divide-and-conquer approach, we were able to cover this territory by traveling to a new country everyday, including The Netherlands, Switzerland, Germany, Spain, Italy, Czech Republic, and the U.K.

The purpose of the Europe trip was business development in each country, and Global Site Audits with various in-country reviewers. KJI meets internationally with the ICRs as part of our annual quality control evaluation, allowing us to gain invaluable feedback. In turn, we share our findings with our clients’ North American headquarters in the interest of continuous improvement.

In addition to the Europe tour, KJI sales team members also traveled to the south-central region of the United States and out West. Our California representative was on the road for an entire week working SoCal. Like I said, we strive to take advantage of being in the area!

Other sales travel included week long travel to the Denver area as we attended ASTD International Conference and Expo. Attending ASTD fosters insight on the eLearning and training industry that’s become a billion dollar business and growing translation requirement for our clients’ HR, training and development initiatives. KJI’s attendance at ASTD allowed us to form alliances and partnerships with those exhibiting new process and technologies from eLearning module developers to LMS providers.  KJI gained knowledge in both the market trends and challenges our clients face with translation and localizing training material for global human resources and market development.

With summer in sight, our travel will simmer down. Ciao for now, and we’ll report back where we take our business next or where our business next takes us!

Susan Anderson loves her work and its travel opportunities as a Senior Global Account Manager. Outside of KJI, you might see her running outdoors or attending a live music show. Contact: sanderson@kjinternational.com

Kristen Giovanis

Good strategic planning will help realize benefits of an e-labeling initiative. Benefits like improved patient care, faster processes, and improvements in information control, storage and distribution. This week and next we’ll drill down on six strategies that can help you know if the time is right to execute an e-labeling initiative. This week we suggest analysis, feedback and diversity:

·Create a Return-On-Investment Analysis: A cost-benefit analysis is a primary tool for weighing current costs versus e-labeling costs and benefits. Make the analysis as detailed as needed, but consider breaking the analysis out by products currently in the marketplace and those that have not yet been introduced. For products currently in the marketplace, what are the pros and cons of moving toward e-labeling based on risk assessment and factors such as expected lifecycle in the market and scheduled revisions? While you are there, look carefully at how competitive products will be affected or even repositioned by the effort. Could e-labeling present an opportunity to refresh the brand? For new products, consider the number of markets, languages and user-types who will come into contact with the product, as well as the expected number of labeling updates. Products expecting few updates may be managed best with traditional labeling, while products expecting multiple updates in several languages may offer a better cost-benefit ratio by moving to e-labeling.

·Seek User Feedback: No matter where you are in taking action on e-labeling plans, keep talking with customers and users about their attitudes toward e-labeling. How much do they know about e-labeling? What do they expect from e-labeling in their practices and professions? How comfortable are they using these technologies and what are their technical capabilities for accessing e-labeling information? What are their fears about e-labeling? If users are eager for e-labeling, it will be much easier to introduce than if users say they wed to paper and will walk away. Start communication early and revisit it often is a way to remain grounded in the realities of how the market operates.

·Look for Technology Updates that work for diverse interests: Few medical device companies have truly up-to-date technology capabilities for single-source content management. If your plans include developing this technology, take time to conduct a thorough information management audit to learn what your information assets really are and how close you are to maximizing their use. Identify gaps in information technology capabilities and develop a strategic plan for technological evolution that takes into account regulatory requirements, labeling needs, translation, publication and data access.

Next up:  E-Labeling Strategy—Part 2: Revisions, Regulatory and a Reality-Check

Kristen Giovanis is CEO of KJI, a leading localization service provider based in the United States. Giovanis holds a Juris Doctrine with a focus in global regulatory law from William Mitchell College of Law and frequently advises life science manufacturers on global labelling and language compliance. Contact:kgiovanis@kjinternational.com. You can follow @kjintresources on Twitter.

The European Union E-labeling Directive will take full effect in March of 2013—and there is much debate and discussion over what exactly that directive will mean. Kristen Giovanis, CEO of KJ International Resources, anticipates the changes and opportunities in her article “Strategies and tactics for preparing a company for Electronic Labeling.” The article appears in the May 2012 edition of the well-regarded Journal of Medical Device Regulation. Click here to get to the journal for more information.

Michelle Vance

Congratulations to Sarah Wollenhaupt, KJI’s Employee of the Quarter. Sarah is a Senior Project Coordinator at KJI and enjoys being outside with her dog, swimming, running and refinishing furniture.

A big thank you to Joey Lee for painting an original mural in our Minneapolis office conference room divider door!



Michelle Vance is KJI’s Vendor Manager. She has a degree in International Relations and is interested in the relationship between language and culture. Contact: mvance@kjinternational.com. You can follow @kjintresources on Twitter.

Molly O C Rowan

In the basic workflow of a translation project, the last step is layout validation. Translators review the document to validate the language, confirming that there were no errors when the material was migrated out of the CAT tool. At the same time, QA ensures that the formatting matches the source while being fully localized and that translators have followed any specific instructions provided by the client.

Most QA at KJI have language experience of some kind. For me, it’s a small treat to work on a file that’s been translated into a language I’ve studied – maybe I’ll learn some new words! But sometimes, my awareness of the language (instead of just the layout) has helped me see things I otherwise might not: accidentally duplicated paragraphs or languages in the wrong order in multilingual files. Occasionally, if there are inconsistencies or deviations from the source, I may have questions for the translator.

I trust our translators. They’re language professionals that work hard at their craft, so when I have questions, I’m sure to phrase them as the start of a dialogue. Sometimes all I need is a quick explanation, and sometimes we need a revision to the translation – but it’s QA’s job to see the document as the client does as well as how the translator sees it. If there’s a discrepancy between the source and the translation, I want to know exactly why a translator has deviated from the source. That way if the client ever questions, I have an answer: we’ve already thought of that.

Molly O C Rowan is a Localization & QA Specialist at KJI. She has a degree in Linguistics and loves language, books, and her dog. Contact: mrowan@kjinternational.com. You can follow @kjintresources on Twitter.

Andrea Lind

Meet Augie.

Augie grew up nearby in Northeast Minneapolis and attended school at the University of Minnesota, where he majored in Broadcast Journalism, and Hennepin Technical College, where he graduated as a Video Production Specialist.  He is a father of 3 – a rock-n-roller at heart – and has been a Business Development Specialist for the Sales department of KJI since November of 2008.

As as seasoned KJI-er, Augie starts his days by following his several call lists.  These are comprised of established clients, prospects, and new client opportunities.  This aspect of business fits Augie well – he enjoys getting new business and hearing clients say they quoted with KJI because of his “persistent and professional pursuit.”

Before KJI, Augie was working part-time in Customer Service, and KJI was a good opportunity for him.  He loves working in Minneapolis because he lives nearby, so if the freeway is backed up, he doesn’t have to sit in it – he knows of other quick routes to get home!  Smart guy.

Get to know a KJI-er:  Q & A with Augie!

What’s your dream job?

I’d be a Video Producer who worked on commercials, news, or political and special interest pieces

Which job would you not want to have?

Collections, Corrections, Tow Truck Driver, or any job where you’re going to have conflict every day

What’s the best advice you ever received?

Decide

What is the one thing you’d be willing to practice all day?

If I had the time, I’ve always wanted to be a monster body builder

Do you speak another language?  If not, which would you like to learn?

I took French in school and visited family who lived in Paris, but I’m half-Mexican and have always wanted to learn Spanish

What do you like to do for fun?

I play drums and monkey around on the guitar.  I like to work out when I can, and I love to mentor my kids

What was the funniest thing you have ever experienced?

My own cynical sarcasm, which not everybody gets

If you could stay a certain age forever, what age would it be?

27, because you’re old enough to know better and young enough to do it again!

What is one of your favorite quotes?

Whether you think you can or you can’t; you’re right!

If you could be invisible for a day, what would you do?

Just watch how people act when no one’s around

What are 3 things you cannot live without?

My kids: Sierra – 14, Chase – 12, and Caitlyn – 9

Andrea Lind is a Project Coordinator at KJI. Contact: alind@kjinternational.com. You can follow @kjintresources on Twitter.

Kristen Giovanis

The world of technology moves fast. The world of regulatory? Not fast.

While there may be more technology-based e-labeling capabilities today compared to five or even three years ago, no technology will solve every issue arising from EU labeling directive. But smart planning and astute technology deployment will help manufacturers position themselves to benefit from e-labeling opportunities.

Content management technology seems a hand-in-glove fit with e-labeling solutions. More and more manufacturers seek to manage massive data resources through content management systems (CMSs) and enterprise management systems (EMSs). Whether relying on proprietary systems or the ever-growing options for off-the-shelf applications, companies using robust CMS and EMS tools can have single-source control of content for everything from technical publications to training material. These tools–when managed correctly—will provide the most up-to-date and accurate information at a user’s fingertips. New publications, translations, updates and releases can be managed through a central administrative system, and multiple outputs (paper-based, e-based and a combination of the two) can be generated from the same source materials.

Proper implementation of a CMS and/or EMS requires strategic planning and resource allocation and careful review of ever-changing technological capabilities. But moving in this direction will help you be ready to achieve the benefits of e-labeling, while maintaining some traditional labeling, depending upon the needs of their users and markets.

Next up:  Putting an E-Labeling Strategy in Place—Part 1

Kristen Giovanis is CEO of KJI, a leading localization service provider based in the United States. Giovanis holds a Juris Doctrine with a focus in global regulatory law from William Mitchell College of Law and frequently advises life science manufacturers on global labelling and language compliance. Contact:kgiovanis@kjinternational.com. You can follow @kjintresources on Twitter.