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Text Comparison in Regulated Industries


Pharma Industry

In the Pharma industry there are two standards that are used as Briefs

  1. Structured Product Labelling (SPL) followed by the FDA
  2. Quality Review of Documents (QRD) followed by the European Medicines Agency

In the CPG industry there are no such standards.

text

In the regulated markets, the SPL content (or extracts from it) are available as a Word document and this is the brief document given to the designer. The Word Document is typically a single column file while the PDF version of it from the designer is a multi-column version. The text flow does not always start from the first column in the PDF. Depending on the folding pattern of the leaflet or PIL, the text could start at the beginning of the last column and flow all the way to the first column.

This constant jumping across columns and matching them with text in the PDF file, make manual proofing cumbersome, tedious and error prone.

The QRD content is typically used to share text placed in labels. The placement of text on the label could be in any direction. The same text in the brief could be placed multiple times in the label. If the text 5 mg is used thrice in the label, the proof reader has to make sure it’s correct in all instances. When multiple components (label and carton) are prepared for the same SKU, the designer has to make sure that certain text content is the same across both the components. The Proof reader has to not only check the accuracy in one component artwork, but also make sure that the same content is available across multiple components of the same SKU.

Such requirements make the need for automated proofing mandatory rather than being a nice-to-have.

Text Comparison in CPG Industry

With no standards available in the industry, each company has its own formats. However, there is a common pattern across most of these briefs. They are in one of these formats:

  1. In the form of a 2 column table in a Word Document. The first column has the names of the sections (e.g. Ingredients, Nutrition, Manufacturing address, etc.). The second column has the text against these section titles which the designer will use to cut-and-paste into the artwork.
  2. In the form of a 2 column Excel Document. Its very similar to the Word Document described in 1, but managed as an Excel file.
  3. In the form of a Word Document with H1, H2 or H3 headings for the section names. The text within each heading is used by the designer for creating the label.
  4. There are of course variations of the above used by many companies

To be continued…In our next blog, we will discuss about automated text comparison.

ManageArtworks is a Packaging Artwork Management Software that helps regulated industries like Pharmaceuticals and CPG to ensure regulatory compliance of their pack labels. It connects all stakeholders into an automated workflow, empowers users with sophisticated proofing tools including Text Comparison tools that reduce errors and speed up the process and gives complete transparency to the entire process with approval request tracking, audit trails and dashboards.

ManageArtworks is available as a ready to use cloud product or as a configurable on premise solution.

Click here to know more.

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