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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Article source: Newswire Today
Source:
Global Vision's Text Comparison Software Docu-Proof Recognized by the EMA for Regulatory Submissions
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