Nobody is introducing these risks on purpose, of course. Graphic designers who work either in-house or as third-party contractors for life sciences organizations face professional challenges unique to the industry. Not only do they need to create top-notch visuals, but they also need a deep understanding of the regulatory environment in which they operate.
Because it’s not realistic to assume that all graphic designers will follow all regulatory best practices all the time, it’s helpful to understand how to find these hidden risks and how to prevent them in the future.
This blog post will help you understand:
Problem #1 – PDF Conversion Issues
Graphic designers use design applications such as Adobe Illustrator and Adobe InDesign to create labeling artwork. These design applications are expensive and complex, so it makes sense to convert the designs from the native file format to a more common document format for internal review, and also to send to the printer once the design proof has been approved.
The current standard for artwork design proofs is PDF.
Problems can arise when the recommended method for exporting to PDF from a given application is not used.
Here are just a couple of examples of problems that can arise when best practices are not followed:
Checking for PDF Conversion Issues
You can check for text corruption by copying the text from your design proof and pasting it into a text editor (e.g., Notepad). If you can read the text in Notepad and it matches what’s in your design proof, there is no text corruption.
You can also use text-to-speech to have the document read back to you. If text-to-speech works properly, there is no text corruption.
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For embedded fonts you can use Adobe Acrobat (or Acrobat Reader). Go to File/Properties and look at the Fonts tab to see which fonts have been embedded in the document.
How to Prevent PDF Conversion Issues
Understand best practices for PDF conversion and the issues that can arise when those best practices are not followed. Each design application has its own recommended method for converting from native format to PDF. Make sure you adhere to the recommendations for your chosen design application.
Also, consider preflighting your PDFs before sending them to the printer. Preflighting is an industry term used to define a set of preparedness checks run against a PDF to make sure it is print-ready. Most design applications come with built-in preflight functionality, but there are also third-party tools available.
Problem #2 – Vectorized/Rasterized Text
We’ve already touched on Unicode in this article as a global standard for allowing machines and software applications to read text accurately. Vectorized and rasterized text represent two more ways that you might be able to read text on your screen (or in a hard copy) with your own eyes, but a machine or software application would not be able to read that same text.
Rasterized and vectorized text are slightly different from each other in practice, but for our purposes they both represent the same problem, which is that there is no Unicode behind the characters.
Removing Unicode from the text in a design proof should only be done when absolutely necessary. Here are some examples of ways that rasterizing/vectorizing the text in your design proofs can cause problems:
Checking for Rasterized/Vectorized Text
This is the same as in the previous example. Either try to copy the text into a text editor or have the text read to you with a text-to-speech application. Live text will copy into a text editor with no problem and will be picked up by a text-to-speech application. Rasterized/vectorized text will not.
Problem #3 – Reading Order Issues
In design applications, text always goes in a text box, and these text boxes can get dragged around, reordered, deleted and added as a design goes through revisions. Each one of these text boxes has a “reading order tag,” and these reading order tags are created in the order that the text boxes are created. As a result, if you create four text boxes, then shift them around on the page so they’re not in the original order, your reading order tags are now out of order.
The big issue here is accessibility.
If you’re planning on making documents available to the public, you need to understand that text-to-speech applications will read the text in the order indicated by the reading order tags. The absolute best-case scenario here would be confusion. Worst case scenario would be some sort of adverse event due to out of order instructions in an instruction for use (IFU).
How to Check for Reading Order Issues
Again, this is the same as in the previous examples. Either copy the text into a text editor or open the document with a text-to-speech application. If your reading order tags are correct, the text in the text editor/text-to-speech application will be the same as what you see in your PDF design proof. If there are problems, the order of the text will not match in some places.
How to Prevent Reading Order Issues
Make sure your designers know about reading order tags and what tools they have at their disposal to edit/reflow reading order tags (options may vary depending on what applications you’re using).
It’s also important for designers to know what (if any) policy your organization has on accessibility, and what effect reading order can have on the accessibility of documents made available to the public.
Problem #4 – Hidden Text
Hidden text is text that has either a) had its color changed to match the background and is now invisible, or b) text that has been placed behind an image or another text box.
The obvious question is why this would ever happen.
There are times when designers are given difficult, or even impossible turnaround times for projects. When this happens, they have a bag of shortcut tricks at their disposal to help them get things done faster.
Sometimes, it’s easier to hide text and put new text right over the top than it is to delete and replace it. For example, maybe my medical device company has a MyDevice5000x and a MyDevice5000i where the documentation for one variation is a subset of documentation for the other. In this case, it might seem easier to simply keep the text for both versions on the title page and then hide/make visible whichever one you currently need.
Accessibility and misprints are the two potential downstream problems that can be caused by hidden text:
How to Check for Hidden Text
You’ve probably guessed how to do this by now. Use the copy/paste method or the text-to-speech method. Any hidden text will appear in the text editor and be read to you by the text-to-speech application.
How to Prevent Hidden Text Issues
On one hand, you’ll want to help your designers understand the downstream implications of dipping into their bag of shortcut tricks.
On the other hand, you’ll also want to help your managers understand what can happen when designers are given unreasonable turnaround times for design projects.
Dan Vuksanovich, MM, MBA, has been solving business problems with technology for almost two decades. After studying classical guitar performance as an undergraduate and graduate student he turned (as so many music students do) to an information technology career path. As an IT consultant and business owner Vuksanovich relentlessly pursued productivity improvements and risk reduction for his clients. Always on the hunt for new challenges, he received his MBA in 2010 and moved into software marketing and sales. With his combined technology, marketing and sales background, Vuksanovich sets himself apart by being able to speak both the language of business and the language of technology.
He is currently regional sales manager for Schlafender Hase covering North America, working with life sciences regulatory, labeling, graphic design and technical writing/editing groups to solve productivity and risk management challenges related to proofreading.
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