Resources / Blog

Strategy, Risks & Benefits of SOP Translation

Oct 24, 2017

In the pharmaceutical industry, precision is critical to success. Bad press from a recall of improperly made medical products can cause reputational damage that lasts for years. This is where Standard Operating Procedures (SOPs) come into play as an essential part of quality control.

An SOP is a set of step-by-step written instructions that document a work routine or repetitive activity performed by employees at a specific facility or organization. In pharmaceutical manufacturing, the main purpose of an SOP is to provide the necessary information for manufacturing employees to perform their jobs properly and consistently so that the end-product is the same every time. For example, an SOP may describe the process for using, calibrating and maintaining equipment that produces insulin for pediatric diabetes.

When a pharmaceutical company makes the decision to outsource manufacturing to a foreign country, SOPs must be translated and localized for foreign workers at the new manufacturing sites. The translated documents must keep the integrity, accuracy and regulatory compliance of these documents intact – which can be a significant challenge. The best strategy for tackling this challenge is to use a pharmaceutical translation service that employs translators who have subject matter expertise in the pharmaceutical industry. This strategy gives pharma companies three important benefits.

1. Ensuring that the original SOP is clear & complete

A translator’s examination of the original SOP document offers an opportunity to fix any clarity issues that it may contain. It is not uncommon for a translator to expose issues or errors that must be corrected in the original. Some examples include:

  • Multiple interpretations – Though the document has likely already been vetted, and may even be the product of delicate negotiations, there still may be passages that are open to multiple interpretations. Such issues quickly become apparent to a translator looking to unambiguously convert meaning into another language.
  • Missing steps – Otherwise unnoticed omissions in the instructions may become obvious to translators as they review the procedural steps. Such omissions can include minor interstitial actions that the original writer skipped by mistake, small details that change between steps, or perhaps an important action that hasn’t been clearly explained.
  • Slang or jargon – The document may contain phrases that are colloquial or employ metaphors that only native readers will understand. Anne Catesby Jones, writing for Translation Journal, cites an example of an instruction to “place a gasket face up.” She points out, “For something to be face up, it should have a face. Does a gasket have a face? The outcome of that inquiry was to eliminate the phrase ‘face up’ and describe how the gasket would fit in to where it should be placed.” Another relevant example Jones mentions is that in English, “check for leaks” does not just mean to check and then move on. It includes the understanding that if any are found, they must be fixed. Subtleties like this are often difficult for a native speaker to spot, but are obvious to a qualified translator.

Note: Changes made to the original SOP should be documented within the SOP’s history section to ensure regulatory compliance.

2. Explaining processes correctly

When translating SOPs, a simple rule must be constantly applied: The SOP must describe processes exactly as they will appear to the operator. If a hardware knob or button is labeled in the native language – or any other language – it must also be referred to in that language in the translated document (right down to the capitalization). Likewise, the electronic text that appears on displays may – or may not – be shown in the language spoken at the production site. Whatever language the operator will see onscreen – regardless of their spoken language – must be identical to what is described in the translated SOP. The purpose here is twofold: it helps to ensure accuracy and reinforces confidence that the translated SOP instructions provided by the pharmaceutical company do, in fact, work.

3. Dealing with terminology

Terminology is an especially tricky area in pharma. Here is how a professional translation service can help:

  • Consistency – Most terminology should be translated. However,certain terms are international and should be left in the original language. Knowing which terms to use – and applying them consistently – is critical to avoid confusion for the manufacturer that is utilizing your SOP. Even if words are used inconsistently in the original, the translated document can avoid this pitfall if it is produced by a professional medical translator.
  • Regulatory knowledge – A certain amount of pharma terminology will inevitably be dependent on regulatory requirements. It is incumbent on a translator performing regulatory translation to have up-to-date knowledge of the applicable local and international pharma standards, and to make sure that the translated SOPs comply.
  • Local brand sensitivity – In the original document, some objects may be identified by commonly understood, trademarked names, such as “Kleenex,” regardless of the actual brand of tissue being used. It’s important to be sensitive to trademarked names that may or may not be internationally recognized. When there are locally recognized trademark names, a certified translator can employ them to better reflect local language usage.
  • Abbreviations – Abbreviations are an area in which the knowledge of a qualified medical translator is critical. Some abbreviations are required for local or international regulatory compliance, some exist only in the original language, and some have local equivalents. Abbreviation usage should be decided on a case-by-case basis by a professional translator who can determine what makes the most sense to the target audience.

SOP Translation Expertise

The rendering of high-quality, accurate, and useful SOP document translation services in pharma manufacturing requires a tremendous amount of knowledge and skill, as well as a native-level understanding of each target language. Using a professional LSP will give you access to a worldwide staff of translators who are experts in pharma manufacturing and have a deep understanding of the various cultures where your translated SOPs will be used.

 

Resources / Blog

Translation Technology Helps Law Firms

Oct 17, 2017

Cross-border business arrangements and international litigation are becoming much more prevalent in our increasingly globalized world. So can translation technology really help law firms save time and improve their service?  Legal translations of the countless number of documents required for international legal proceedings can sometimes be downright overwhelming. Multiply that by the number of countries involved, and it becomes clear why law firms struggle with the gargantuan task of taking on international cases: Getting them done on time, without the exorbitant cost, and executed with the error-free accuracy that the law and regulatory agencies demand – is difficult.

Fortunately, translation technology from a professional language service provider (LSP) can provide an efficient and affordable solution to help lawyers and their teams devise a cost-effective and time-saving translation strategy. Here are the three key types of translation technology you must know about.

1. Machine translation

Machine translation (MT) is an automated, software-based translation process best suited to situations in which there’s a need to quickly translate a large number of documents. MT translations are ideal for:

  • litigation documents
  • reference documents
  • discovery and eDiscovery materials
  • culling unnecessary documents from a large set
  • identifying important documents in a large set that will need further review.

MT is a word-by-word, literal translation process unaware of context or grammatical nuance. It can be a great help in reducing mountains of paperwork into molehills so that law firms can confidently identify which ones need a greater degree of precision. Then, if budgetary constraints allow, MT can be paired with human post-editing to eliminate all errors or potential unclarities in the translated text.

To make MT optimally accurate, some translation companies can provide custom translation technology for MT software engines built around a firm’s specific needs or field of law, which can be integrated with relevant localization projects.

2. Translation memory

There are a number of standardized phrases or paragraphs that appear frequently in legal text. If a firm specializes in a particular area, this is especially likely to occur. For such content, translation memory (TM) offers a powerful tool for speeding up the translation process since it eliminates the need to re-translate the same content over and over again. TM is a software-driven, expandable database of often-encountered wordings and their translations in the desired target languages.

TM scans a document to identify repeat phrases and presents each match — along with its translation — to a human legal translator for review, saving time, money, and, not insignificantly, promoting consistency throughout the final work. As cases proceed and more phrases are added to a client’s TM, the time required for the translation of documents is continuously reduced as more standardized wording is recognized.

3. Terminology management

It’s often the case that law firms will have their own lexicon of terminologies, abbreviations, and brands. To ensure consistent use throughout all translations, a software glossary can aggregate these terms along with their preferred translations. Such a glossary preserves the preferred way of communicating across all translated documents. At Morningside, we can import a firm’s existing glossary, or build a new one that fully represents your way of communicating.

Glossaries can also be integrated with TM databases.

With an LSP relationship in place

As the practice of law becomes ever more multilingual and cross-cultural — even within a single country — technologies such as MT, TM, and glossaries can transform what might otherwise be a laborious, time-consuming, and expensive headache into a streamlined, worry-free process.

 

Resources / Blog

Tom Klein and Roland Lessard featured in Slator

Oct 11, 2017

Morningside is proud to be featured in Slator, the leading translation industry website, where our new owner-operators and co-CEOs Tom Klein and Roland Lessard discuss why they entered the language services industry, why they chose Morningside, and their future plans for the company.

Enter the Operators: Morningside’s New Owners Bet Big On Language Services

 

In late May 2016, one of the larger language service providers (LSPs) in the United States changed hands. Morningside Translations, a New York-headquartered LSP that focuses on IP, patent, legal, and other regulated industries, was acquired by a group of individuals led by now co-CEOs Tom Klein and Roland Lessard.

The Engineer and the Banker

Mergers and acquisitions have been red-hot in the language services industry for the past two to three years with new deals announced weekly. But what makes this transaction different from many recent deals is that Klein and Lessard are from outside the language industry. They have taken over Morningside as operators, and not as purely financial investors.

The two have divided up their responsibilities. Lessard, a Connecticut native with a background in engineering, manages operations and related areas. Klein, who started his career at Goldman Sachs’ investment bank, has a more sales-focused, client-facing role.

Lessard and Klein met nearly a decade ago when they were both working at the background check company Sterling Talent Solutions. “Roland and I both served on the executive committee at Sterling,” Klein says. In 2009, “the company was around the same size as Morningside is today, and we grew it to USD 400m before we left,” Lessard adds.

Some of that growth came from acquisitions. Klein ran Sterling’s corporate development function for three years and says the company acquired about seven companies during his tenure.

In the middle of 2015, Sterling was bought by Principal Investment Area, Goldman Sachs’ private equity arm. Klein says the sale was a “logical time to leave” and move on and try new adventures.

Talking to over 50 LSPs

So what drew them to language services and why Morningside? Klein says, “I have to give credit to my partner, Roland, who found the language services space.”

The two partners saw that the language industry offered strong fundamentals. As Lessard explains, “We felt very strongly about the macro tailwinds driving the growth of the space — everything from the explosion of digital content to mobile internet adoption to the globalization of the world, and then where translation services is in the product life cycle.”

“We felt very strongly about the macro tailwinds driving the growth of the space” ― Roland Lessard, co-CEO, Morningside Translations

After deciding on language services as their target industry, what followed was an exhaustive process to identify and vet a suitable company to acquire.

“We spent the next year meeting with owners and ended up talking to over 50 LSPs and a couple of dozen industry experts, really diving in headfirst. That was a very significant effort to really try to get up to speed and get smart and decide how and where to play in language services,” recounts Klein.

Competition for LSPs with a certain scale has become intense over the past two years, with both strategic buyers and private equity firms alike competing for companies in the USD 20m to USD 40m range.

While the co-CEOs did not disclose whether the Morningside process was competitive, Klein shares that they liked the company for its industry vertical mix and growth track record. According to Klein, Morningside’s compounded annual growth rate has been close to 30% annually over the past five years.

“We ended up talking to over 50 LSPs” ― Tom Klein, co-CEO, Morningside Translations

Morningside has traditionally been strong in industries such as intellectual property, patents, and legal, where demand is often determined by regulatory requirements. Klein says they are also building out their life sciences business and do a significant volume of work in e-learning.

Exposure to regulatory industries has been sought after in recent years as demand from large enterprise IT accounts faltered with Lionbridge acquiring CLS Communication as early as 2014. Welocalize, RWS, and others are also looking for growth in those markets.

Klein is confident that growth in areas such as legal (e.g. cross-border litigation, international arbitration) or the life sciences (e.g. medical devices) is set to continue.

Geographically, Morningside is centered in the United States and has sizeable operations in Germany and Israel. When asked about Morningside’s top five target languages, Lessard lists Japanese, French, Chinese simplified, Spanish, and German.

Competition in regulatory verticals is fierce. According to Klein, Morningside’s top three competitors are Welocalize-owned ParkIP, Utah-based Multiling, and the language industry’s new juggernaut RWS, whose share price marks a new high almost daily.

No One-Trick Pony

In terms of translation management and productivity tools, Morningside chose to buy instead of building and deploying a combination of Plunet as TMS and memoQ for translation productivity.

But like so many other LSPs Lessard says they are open to using other tools if a client requires it. “I think being a one-trick pony when it comes to an MT or TM offering is a big mistake. We feel that you have to have the ability to connect to many,” he says.

Morningside sources from both individual freelance translators and single-language vendors.

A Long Game

Do the rapid progress in machine translation and related language technologies worry the two co-CEOs? Do they see machine translation as a threat, in particular in a vertical like patents and IP, where there are troves of well-structured reference corpora which neural MT models can feed on?

While Klein acknowledges that certain technical content in IP may be vulnerable to competition from pure MT, he stresses there are many areas that will continue to require human expert translators in the foreseeable future. “There are many elements in IP that are extremely challenging and where word ordering and syntax is unbelievably important,” he says.

How does the CEO duo plan to develop the company going forward? Lessard says their growth strategy is based on four pillars: pursuing organic growth; introducing new products and services into existing segments; seeking channel partnerships in areas such as e-discovery, forensics, or litigation support; and, doing acquisitions. On acquisitions, Klein says “the way we capitalized the business [we have] plenty of ability to do bolt-on acquisitions when desirable.”

“There are many elements in IP where word ordering and syntax is unbelievably important”

Unlike a financial investor who typically has a four- to six-year exit horizon, the two co-CEOs, both in their late 30s, are not planning to flip the company any time soon. “This is definitely a long game,” Lessard says.

Perhaps making a dig at crosstown rival TransPerfect, Klein adds that he and Lessard “have a lot of faith in each other, and we trust each other. The co-CEO model doesn’t work everywhere.”

To grow the business, the two operators have their work cut out for them. With no significant proprietary technology, they will have to make smart acquisitions and invest in their sales force to gain market share in their core verticals.

They will also have to increase the company’s international presence and plant more flags on the map if they want a seat at the table in large RFPs issued by big global buyers. This will require a significant investment in technology and in people and take up precious management time.

The competition will be watched closely.

https://slator.com/ma-and-funding/enter-operators-morningsides-new-owners-bet-big-language-services/

Resources / Blog

When to Use Interpretation vs. Translation

Oct 10, 2017

As a leading language solutions provider, we know that people can be uncertain about the difference between — and appropriate use of — interpretation services and translation services.

Both are forms of conveying meaning from one language into another — and both require highly developed language skills — but they are two very different things.   

 

Choosing the right service

At the most basic level, interpretation deals with spoken language while translation is used for written language. Here are four important differences:

1.  Timing 

  • An interpreter works in real time or with only a slight delay on-site or on the phone. 
  • translator works on a document after it’s been written, which means there’s time to consult with subject matter experts and employ dictionaries and other resources as needed. 

2.  Accuracy 

  • An interpreter must faithfully distill and convey the meaning of the original speech instantaneously, and therefore may at times omit less-critical details. 
  • translator converts from one language to another with every single detail adapted to the final language.   

3.  Fluency 

  • An interpreter must be fully fluent in both languages so that he or she can seamlessly convey meaning from one language to another. 
  • translator typically translates from a foreign language into his or her own native tongue. As such, a translator must understand the foreign language, but not as fluently as their own tongue. (Remember, translators have the luxury of reference materials while interpreters don’t.) 

4.  Subtleties 

  • An interpreter must be conversant in both languages’ cultural expressions, metaphors and slang. Additionally, interpreters must transmit verbal nuances like tone, pitch, volume, speed and inflection. 
  • translator must recognize and understand the original language’s idioms and metaphors, and be able to convert them into those of his or her native language. 

 

Types of interpretation  

There are two main modes of interpretation:  

  • Simultaneous — Simultaneous interpretation takes place in real time, with the interpreter converting a speaker’s words and meaning into a second language as he or she is talking. The interpreter may be in a booth, listening on headphones to the original speaker and interpreting into a microphone for the target-language audience (which may include other interpreters reproducing the content in their own native tongue). They may be seated or standing near the target listener or audience, whispering the interpretation, or as a participant in a conference call. The instantaneous nature of simultaneous interpretation makes it indispensable for a range of settings, including meetings or conferences, and it can be a critical asset in legal and medical contexts. Since it’s highly demanding for the interpreter, it’s common practice to have two interpreters working together, relieving each other periodically.  
  • Consecutive — Consecutive interpretation takes place when a speaker pauses periodically to allow an interpreter to convey his or her most recent statement to the target audience before proceeding. The interpreter typically sits or stands next to the speaker, taking notes as needed to help relay everything the speaker just said.  

Both types of interpreters should understand the subject matter at hand. In a hospital context, there are medical interpreters; in a court room, there are interpreters who specialize in legal interpretation – all of whom must convey thoughts and concepts clearly, and work well under pressure.  

 

The translation process  

Professional translation services use a multi-step process involving a combination of Computer-Assisted Translation (CAT) tools and human expertise to provide high-quality translations of written materials. A typical workflow might look something like this: 

  • The process begins with the source material being converted into a data format — typically Rich Text Format (RTF) – that can be understood by Translation Memory (TM) software.  
  • TM software searches for and retrieves existing translated text that matches the content of the current work to help ensure accuracy and consistency across projects.
  • A human translator fluent in the target language goes over each of these matched sections, and makes corrections as required.  
  • The translator translates remaining content that hasn’t been matched to previously translated text.  
  • A second translator fluent in the target language proofs and edits the first translator’s work, making refinements as necessary.  
  • Desktop publishing restores the document as closely as possible to its original English design and layout so that the finished translation looks just like the original. 

Another popular tool your language services provider can utilize is Machine Translation, an automated translation process that gives readers the “gist” of a document. Machine translation is often paired with human post-editing for projects where higher quality is required but the budget is limited.    

 

Making the right choice  

In today’s ever-shrinking world, it would be hard to overstate the importance of clear, accurate communication across languages and cultures. At the center of these international conversations are skilled and dedicated interpreters and translators whose hard work helps ensure that we understand each other, and who help make it possible for us to realize the potential in what we might accomplish together. 

 

Resources / Blog

Financial Services Providers: Are You Prepared for New PRIIPs Regulations in the EU?

Oct 03, 2017

Starting on Jan 1, 2018, EU manufacturers of packaged retail and insurance-based investment products (PRIIPs) will be required to provide their investors with annually updated Key Information Documents (KIDs). These standardized documents are meant to help investors make more informed decisions on whether an investment is right for them. KIDs were introduced by EU Regulation No. 1286/2014 and are part of the EU’s greater plan to help rebuild investors’ confidence in the financial market in the aftermath of the global financial crisis.

 

Are you going to be affected?

 

According to Article 6, “This Regulation should apply to all products, regardless of their form or construction, that are manufactured by the financial services industry to provide investment opportunities to retail investors, where the amount repayable to the retail investor is subject to fluctuation because of exposure to reference values, or subject to the performance of one or more assets which are not directly purchased by the retail investor.” Examples of PRIIPs include investment funds, life insurance policies with an investment element, structured products and structured deposits.

The legislation goes on to clarify that it’s not talking about the kind of investments that involve buying or holding assets themselves. Instead, it’s referencing “products [that] intercede between the retail investor and the markets through a process of packaging or wrapping together assets so as to create different exposures, provide different product features, or achieve different cost structures as compared with a direct holding.”

 

The purpose of KIDs

 

Investing in the PRIIPs market is a complicated and potentially risky venture to the uninformed consumer. As noted in Article 1 of the new Regulation, “Existing disclosures to retail investors for such PRIIPs are uncoordinated and often do not help retail investors to compare different products, or understand their features. Consequently, retail investors have often made investments without understanding the associated risks and costs and have, on occasion, suffered unforeseen losses.”

One reason for the confusion is that up until now, there have been different PRIIPs rules for different industries and countries. Regulation No. 1286/2014 will put an end to those discrepancies in the EU. The new law applies to all Member States participating in the PRIIPs market – full stop. By creating uniform rules on transparency at the Union level, regardless of where the PRIIP manufacturers are located or what they’re selling, Regulation No. 1286/2014 should create a level playing field for disbursement of investor information. It’s hoped that the new mandatory Key Information Documents will enhance investor protection and encourage new investors to enter the market.

 

The procedure

 

A uniform KID template must be followed for all products across all industry sectors. These documents are subject to an overall maximum of three sides of A4 paper and must include the following sections:

  • Purpose
  • Product
  • What is this product?
  • What are the risks and what could I get in return?
  • What happens if [PRIIP Manufacturer] is unable to pay out?
  • What are the costs?
  • How long should I hold it and can I take money out early?
  • How can I complain?
  • Other relevant information

 

KID translations

 

Since the very nature of this law is to provide consumer-friendly documents that are easy to read, understand and compare, it makes sense that the documents will need to be made available in the investors’ native language.

According to the official EU guidelines on Regulation No. 1286/2014, “a KID must be provided in a language prescribed by the [EU] Member State where the PRIIP is distributed in order to ensure that retail investors can understand it.”

If the PRIIP is to be made available cross-border, the PRIIP manufacturer must provide a translated KID for each relevant Member State – and any time a translated KID is made available to retail investors, the PRIIP manufacturer must publish the translation on its website next to the original.

 

Translation quality and liability

 

As the guidelines point out, Regulation 1286/2014 does not provide any references for a reliable translation agency, but it does place responsibility for the accuracy of all translations on the PRIIP manufacturer. As such, manufacturers will be accountable for any mistakes or unclear translations that they provide to retail investors.

To avoid such issues, PRIIP manufacturers should partner with a professional translation company that has a certified quality management system. At Morningside, for example, we are ISO 9001:2015 & ISO 13485:2003 certified. Our quality assurance process includes multiple rounds of editing and proofing with built-in redundancies to ensure accuracy, proper terminology, and correct localization for the target audience. We rely on a team of 8,000+ certified in-country translators with a wide variety of subject matter expertise so that you can feel confident that every document translation is technically accurate.

For help translating your Key Information Documents, contact Morningside for a quote today.