Deregulation and Oversight: Conjoined Twins

FAA, FDA, NTSB, FAA, SEC, NRC. These acronyms for US organizations are household names for many people. They are often followed by a list of other names that may bring up images of fear and fraud: Enron, Madoff, Vioxx, Three Mile Island, Bear Sterns.

The common thread among the agencies mentioned above is that they are in the regulatory business. They regulate areas like health, industry, business and other aspects of life. In a free-market society this means these organizations are trying to ensure a fair playing field. They dole out punishments to those that stand in the way of fairness. Another way to describe what they are doing is regulation and regulatory oversight.

Deregulation and regulatory oversight are related but each has its own objective. Deregulation is aimed at actual de-regulation, enabling companies or organizations to compete in markets that they could not enter before due to legislation of government action. The goal of regulatory oversight, on the other hand, is to define and enforce rules of engagement once the players have entered the market.

In our current free-market society, deregulation and regulatory oversight are both widely considered to be necessary. The debate, often brought on by the surprising regularity in which the agencies or players find themselves on the front pages of newspapers, almost always focused on the extent of: how much deregulation and how much oversight.

The last decades -with the ongoing strides of globaliation- have seen an increasing international effort to join forces across borders when it comes to regulation and oversight. Often players are present in many continents and nuclear radiation or faulty products are not things that can be curbed at the border.

ISO is an example of a global oversight organization. ISO (International Organization for Standardization) is a network of the national standards institutes of 162 countries, one member per country, with a Central Secretariat in Geneva, Switzerland, that coordinates the system. The member body for the US is ANSI (American National Standards Institute).
ISO provides regulation in the form of many different international standards affecting many different industry sectors. In our industry, and in the industry of most of our clients, some of the main standards are:

• ISO 9001:2008: specifies requirements for a quality management system where an organization
o needs to demonstrate its ability to consistently provide product that meets customer and applicable statutory and regulatory requirements, and
o aims to enhance customer satisfaction through the effective application of the system, including processes for continual improvement of the system and the assurance of conformity to customer and applicable statutory and regulatory requirements.
• ISO 13485:2003: specifies requirements for a quality management system where an organization needs to demonstrate its ability to provide medical devices and related services that consistently meet customer requirements and regulatory requirements applicable to medical devices and related services.

Excel Translations abides by the rules that are spelled out in these two standards. In addition, as a player in the field of quality management, Excel Translations is subjected to the ongoing regulatory oversight provided by independent organizations.

Excel Translations has been ISO certified since 1999.



Note:
EPA = Environmental Protection Agency
SEC = Securities and Exchange Commission
FDA = Food and Drug Administration
FTC = Federal Trade Commission
FAA = Federal Aviation Administration
NTSB = National Transportation Safety Board
NRC = Nuclear Regulatory Commission
ISO = International Organization for Standardization)

Science no Longer the Exclusivity of Developed Countries

While emerging countries such as China, India, and Brazil have long been associated with the global scientific community, the presence of Iran, Turkey, Tunisia, and Israel in this very private club may come as a surprise.

A recent study published by the Royal Society, Britain’s national academy of science, reveals that “rapidly” emerging scientific nations, of which several are in the Islamic world, are now embarked on the fast train of science R&D. These emerging countries could soon challenge the scientific superpowers of the West.

Iran, for instance, is the fastest growing country in the world when it comes to the number of scientific papers published in journals. The government of Tehran plans to allocate 4% of its GDP to scientific R&D before 2030. By comparison, the EU average budget for scientific R&D is 1.8% of its GDP. Critics may say that this money will be going toward nuclear research. But the fact is that more and more US scientists are collaborating with their Iranian counterparts on multiple science projects. The number of joint US-Iranian scientific papers published over the past 12 years has increased from 300 to 1,600. And when it comes to science, Iran will go as far as cooperate with its archenemy, Israel. Both countries are working hand in hand on a scientific light source project in Jordan.

But other nations such as Tunisia and Turkey are also thriving when it comes to science. Turkey’s scientific R&D spending has increased six-fold since 1995 and the number of researchers has increased by 43% over the past 12 years. With an R&D budget of 1.25% of its GDP, Tunisia hopes to increase its pharmaceutical exports five-fold over the next five years.

The Royal Society’s report concludes by stating that there are over 7 million researchers in the world today and that the global annual budget allocated to R&D has increased by 45% since 2002. With the arrival of emerging nations, these numbers will surely increase even further. To be continued.

Medical Translation Services “Critical to Quality”

It just makes sense that the text you choose to include in your most important medical product documents (i.e. IFUs, User/Operator’s Manuals, Labels, Technical Specifications, Drug Indications, etc) is critical to the overall quality of how the product is used and prescribed. Words and phrases are carefully selected so that the information is precisely communicated.

Industry best practices dictate that the translation of these documents and text be treated with the same importance. It is an internal requirement for many leading drug and device manufacturers that the medical translation partner the select not only has the experience and expertise in the medical industry, but also has the certifications to back it up.

Now we are seeing this requirement communicated from an authoritative medical industry body. Recently the NBOG (Notified Bodies Operations Group) released a guidance that listed translation services as critical to quality. NBOG has begun to audit international certification organizations, such as BSI, TUV SUD, TUV Rhineland and others, more stringently regarding the manufacturers they register and certify. Where the NBOG is tightening their belt specifically refers to the quality of how and with whom translations are done.

In turn, international testing organizations must audit the manufacturers to the standard that the NBOG dictates. Audits will now require manufacturers to speak to the quality of their medical translations including how they vet and qualify the experience of the translation partner with whom they work. Manufacturers who work with translation partners with specific experience and expertise in the medical industry and can show proof of their vendors’ expertise and experience, will have little to no problems with this critical item during audits. Manufacturers who work with translation partners who are both ISO 9001 and ISO 13485 certified will have this burden of proof through the ISO certificates they have on file from their translation vendors.

File Compression and organization using WinRAR

Many times documentation and files used in translation projects are extremely large due to the volume of text to be translated and/or the amount of images, charts, graphics, and screenshots used in the layout. Many times the layout itself is so complex that it adds to the size of the source file.

There are plenty of applications to compress or “zip up” the files so they can be sent or uploaded easily. The most popular, WinZip, has been around for years. Another popular application that is being more widely used is WinRAR.

WinRAR is a file compression tool for making files smaller and adding multiple files to a single protected archive for safer, easier transfer over networks and via the internet.

WinRAR integrates itself into your Windows shell so that by right clicking on any given documents or files, you have the ability to compress those files, usually into a smaller, more protected format.

Right clicking a file or multiple files gives you the following options:






In this case, I selected Frame Maker.doc on my hard drive and I’m given the following options. If you are doing a single file and you’d like to retain the original name of the file, simply select (in this case) Add to “Frame Maker.rar”, and the program will automatically create a compressed version of this file using the default WinRAR options.

By selecting Add to archive…, you are presented with more options:

















You are given the choice of Archive format, and in this case I’d like to stress using RAR as opposed to ZIP since RAR gives us more options.

If you are using a single file, WinRAR will automatically select the name of your file. You have the option to change this to another name of your choosing which is nice when dealing with multiple files. The extension is automatically .rar even if you delete the entire line and set your file name as, “I LOVE COOKIES”. It will still be I LOVE COOKIES.rar

Another great feature of WinRAR is the ability to split archives into specifically sized volumes.

As you can see, I used my MOV02033.AVI file, right clicked, chose the option in the bottom left-hand corner and chose a specific file size to split my main file into. There are several default sizes, but I prefer to choose my own depending on the size of the file being compressed.

A quick chart on sizes is like this:

1,000,000 bytes = 1 megabyte or 1mb
5,000,000 bytes = 5 megabytes or 5mb
10,000,000 bytes = 10 megabytes or 10mb

You can set this as high or as low as you’d like. Depending on the size of whatever I’m going to compress, I like to create volumes of anywhere from 5mb to 100mb each. When working with extremely large files in the gigabyte range it’s better to use larger split volumes in the 50mb to 100mb range. It will make decompressing the files faster and create fewer archives. Remember, the larger the volume you create, the less archives you create. As you can see in the picture above, I chose to split my main 60mb file into 10mb archives coming out to around 56mb total when compressed.

Once I have my main file split into compressed volumes I no longer need it. It’s basically copied over into 6 smaller volumes (using my example above), and when I unpack those files, it’ll be there whole and intact. Simply by selecting the first volume in the set and then choose to extract it, it will know there’s a set of files related to the first one and unpack your compressed file wherever you choose.

Just remember to select PUT RECOVERY RECORD so that if any damage occurs (data loss) during transfer, the file can be repaired easily by the recipient.

Another nice feature is the COMMENT tab detailed below:

By using this feature you are given the ability to add a note to your archive as shown above. This is really handy for adding extra information, details which were missed or forgotten in a meeting or email, or just saying Hello or Thanks!

WinRAR provides the user with the ability to compress any volume, split it if needed, and protect for it for safe transmission over networks and online. WinRAR is a safe and easy solution for protecting the integrity of your files and archives from data loss due to power failures, internet disconnections, and other mishaps while working with important files. Using WinRAR also saves vital hard drive space where there may be constraints.

It may take a little longer to prepare and send that important document for translation, analysis or cleanup, but at least you can be guaranteed your documents are safe.