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Global Vision’s Docu-Proof Recognized by the EMA for Regulatory Submissions

Friday, May 24, 2013

Press release from the issuing company

EMA reduces submission fees by over 50 percent with the use of Docu-Proof an Automated Text Comparison Software

Ghent, Belgium – Global Vision, the industry leader in the development of automated proofreading solutions, announces that Docu-Proof has met compliance requirements as a text comparison software solution by the European Medicines Agency (EMA) for pharmaceutical companies using parallel distribution methods of medicinal products.

For pharmaceutical companies, deployment of Docu-Proof would result in cost savings of 290 euros per submission versus performing manual comparisons. Currently, the annual update or change notification fee without using an approved text comparison solution is 570 euros  per  submission. With Docu-Proof the annual fee is reduced to 280 euros.

“We have worked diligently with our pharmaceutical customers to ensure that Docu-Proof meet the EMA compliance requirements,” explained Peter Muller, VP Business Development for Europe, Middle East, Africa and Asia at Global Vision. “Docu-Proof exceeds the EMA requirements with additional technology such as medical spell-check and complex table handling.”  

“For additional cost savings, Docu-Proof’s concurrent licensing allows users to share the software across multiple locations,” continued Peter Muller.

To learn more about the new program from the EMA and how current customers are already benefitting from Global Vision Solutions please visit us at The Total Processing & Packaging Exhibition, booth L41,  04-06 June in Birmingham United Kingdom, or by email at info@globalvisioninc.com.

Meeting Compliance

Docu-Proof has been recognized as a text-comparison software that preserves data integrity of the documents and is designed to detect deviations between the package leaflet and the text of the annexes:

EMA Deviation measurement requirements

  • Sub / super: change between regular, superscripted, or subscripted text;
  • Change: Text found in the leaflet that replaces the text in the annex;
  • Deviation: Text found in the leaflet that is not identical to that in the annex, e.g. typographical errors, grammatical mistakes, etc. Please note that if an error is found in the annex, the parallel distributor should inform the Agency by mentioning the error in the report;
  • Deletion: Text found in the annex that is not in the leaflet;
  • Insertion: Text found in the leaflet which is not in the Annex;
  • Hyphenation: change due to a software-generated hyphen inserted at the end of the line or due to an addition or removal of a hyphen.
  • Case: upper- and lower-case differences;
  • Space: change due to an actual space inserted between characters vs. no space.
  • Style changes:
    • bold: changed font style (whether text is bold or not);
    • italic: changed font style (whether text is italic or not);
    • underline: change due to text being underlined or not;
    • size: changed font size. Please follow the readability guidelines (font equivalent to Times New Roman 9 for the package leaflet).


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