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Global Vision's Text Comparison Software Docu-Proof Recognized by the EMA for Regulatory Submissions - With Docu-Proof, annual EMA update and change notification fees reduced by 50% - GlobalVisionInc.com
Global Vision's Text Comparison Software Docu-Proof Recognized by the EMA for Regulatory Submissions

 

PRZOOM - /newswire/ - Montréal, Québec, Canada, 2013/05/22 - With Docu-Proof, annual EMA update and change notification fees reduced by 50% - GlobalVisionInc.com.

   
 
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Global Vision, the industry leader in the development of automated proofreading solutions, today announced 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).

About Global Vision
Global Vision (globalvisioninc.com) is the world leader in the design and delivery of automated proofreading solutions. Its complete suite of advanced solutions featuring text-based, pixel-based and Braille inspection technologies are designed to eliminate printed artwork, text verification, and text comparison related errors, providing end-to-end security at every stage of the workflow process.

Global Vision solutions are widely interoperable and have received commercial endorsement from the world’s leading Pharmaceutical, Consumer Packaged Goods (CPG), and Artwork Management companies.

 
 
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Agency / Source: Global Vision, Inc.

 
 

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Global Vision's Text Comparison Software Docu-Proof Recognized by the EMA for Regulatory Submissions

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Contact: Press Office - GlobalVisionInc.com 
514-624-4422 mspooner[.]globalvisioninc.com
 
PRZOOM / PRTODAY - Newswire Today disclaims any content contained in this article. If you need/wish to contact the company who published the current release, you will need to contact them - NOT us. Issuers of articles are solely responsible for the accuracy of their content. Our complete disclaimer appears here.
IMPORTANT INFORMATION: Issuance, publication or distribution of this press release in certain jurisdictions could be subject to restrictions. The recipient of this press release is responsible for using this press release and the information herein in accordance with the applicable rules and regulations in the particular jurisdiction. This press release does not constitute an offer or an offering to acquire or subscribe for any Global Vision, Inc. securities in any jurisdiction including any other companies listed or named in this release.

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