Global Vision Text Comparison Software Docu-Proof Recognized by the EMA for Regulatory Submissions With Docu-Proof, annual update and change notification fees reduced by 50%
05/21/2013 11:09:10 AM
Published Date: May 21, 2013 11:09:00 AM EDT
MONTREAL, May 21, 2013 /PRNewswire/ -- 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 meets 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 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 firstname.lastname@example.org.
Docu-Proof has been recognized as a text-comparison software that preserves data integrity of the documents:
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;
- 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.
- Case: upper- and lower-case differences;
- Space: change due to an actual space inserted between characters vs. no space.
- bold: changed style;
- italic: changed style
- underline: change due to text being underlined;
- size: changed font size.
SOURCE Global Vision