“A different language is a different vision of life,” said the Italian film director, Federico Fellini. When we proofread pharmaceutical packaging and labelling, this can take on a very literal meaning. Braille for the blind or partially sighted has been mandatory on external packaging of medicines sold within the European Union for a number of years. And of course, all packaging and labelling must appear in all required official languages that can easily be understood by patients.
But what is the best way to accurately check for errors in Braille or a language we don’t understand? If you’re proofreading manually, it’s a real challenge.
Coming to grips with Braille?
First some background: Article 56a and amendments of “Directive 2001/83/EC of the European Parliament and of the Council “lay down clear instructions for marketing authorization holders to ensure that packaging includes the name of the product in Braille. It also states that the marketing authorization holder must ensure that the “package information leaflet is made available on request from patients’ organisations in formats appropriate for the blind and partially-sighted.”
If you are proofreading packaging and labelling, then at some point in your workflow you will need to verify Braille. One common method of doing this is to insert Braille twice, once in the printed area of the artwork for a folding box, and again outside the print area with a translation in letters for proofreading. But this is still prone to error. Unless you are an expert Braille reader, it will be virtually impossible to proofread manually with the accuracy and certainty required.
In an industry where packaging and labelling mistakes can put patient lives at risk, result in expensive recalls and damage the reputation of brands and companies, the stakes are high.
Foreign languages present the same challenge
Foreign languages can present the same challenge in a global economy where products must have multilingual packaging or are exported to different countries or regions. Proofreaders who are still proofreading manually will be aware of how time-consuming it can be to send documents back and forth across subsidiaries for correction. Revisions, approvals, revisions of revisions – it can get messy and time-consuming.
While obviously a native speaker skilled in the local language will be required to verify the accuracy of a local language in an original master document, each manual revision of packaging-related documents (e.g. an artwork file in PDF) requires re-reading the entire document to ensure no new errors have been introduced.
Yes, there are manual workarounds, but that’s not enough
There are manual solutions to proofreading Braille and foreign languages.
You might use workarounds for Braille, like comparing each Braille pattern to the character on a Unicode code chart. Unicode is a standard that assigns a unique code to each letter, number and symbol in most languages around the world. We’ll come back to this shortly because it’s the basis for automated proofreading software.
Another technique is to select the text in the PDF copy (making sure the text is live) and copying it into a Notepad. This will convert the Braille to a letter. You may also check that the coding of letters and numbers is correct. In most languages, the symbol # is inserted before a letter in Braille. “#Be mg”, for instance for a dosage, is “25 mg”.
While these are useful tips, especially for those drafting original documents, we’re still not at the best solution for proofreading, say, artwork with Braille in PDF format against the original.
How it works
TVT compares a master document to a final version and highlights deviations between the two. The documents can be in different layouts and formats (e.g. an approved Word document compared with artwork in PDF format), or in virtually any language (including non-Latin scripts such as Arabic, Hebrew and Korean, or even Braille) and reading direction (right to left). Formats such as tables are also easy for TVT. It finds deviations by inspecting Unicode, the unique computer code for each letter and symbol, as opposed to the actual words, letters and characters themselves. The steps to compare the two documents are simple and straight-forward, carried out on an intuitive interface with a few simple clicks.
All steps (reviews and actions) are documented, adding transparency to the proofreading process by creating an “audit trail”. This trail adds more certainty, greater accountability and more proof of accuracy, making the task less stressful. And let’s face it, you can lose a lot of sleep in the pharmaceutical sector over the niggling doubt that an error might have been overlooked, whether it’s a misprint or the accidental inclusion of unapproved text.
Automated proofreading offers the solution
Let’s return to Unicode for a moment. Many proofreaders in the pharmaceutical sector especially will be familiar with TVT, our Text Verification Tool. TVT compares an original “master” document to a copy, often an artwork document in PDF, and highlights any deviations for correction. It does this by comparing the Unicode in the two documents.
And here we have the solution for proofreading both Braille AND foreign language versions quickly and efficiently. Comparing original and copy documents can be done in seconds with a few intuitive steps. The proofreader can also annotate the document with corrections and instructions, save or print an annotated PDF, and create a report as an audit trail to document all actions. This creates accountability and transparency, which is especially important in difficult proofreading circumstances such as checking Braille or foreign languages. And, of course, it’s important in an industry where mistakes in labelling and packaging can have such severe consequences.
As part of the revision cycle, the proofreader can perform a correction comparison to verify that all the requested changes have been implemented in the new artwork version – and that no new errors have been introduced.
Help your proofreaders with a new team member: TVT
Proofreaders in the pharmaceutical and medical devices sectors are skilled professionals who have often developed their own approaches to proofreading foreign languages and Braille. However, against a backdrop of increasing workloads and ever-changing regulations, it makes good sense to dispense with high-risk manual proofreading and reduce risk while increasing output through automated proofreading.
Would you like to find out how we can help you proofread faster and with more accuracy? Get in touch with us.