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OpenText Electronic Common Technical Document for Content Suite Platform by Stra

By  STRATESYS TECHNOLOGY SOLUTIONS, SL

Electronic Common Technical Document for Content Suite Platform by Stratesys is an OpenText Content Suite Platform add-on to accelerate your product global eSubmission Process.

Electronic Common Technical Document for Content Suite Platform by Stratesys is a modular solution part of GxP Suite and designed to help the Regulatory Affairs department of a Life Science organization to improve and innovate its Dossier Preparation and eSubmission Process. Covering the full eCTD generation process until the export of a ZIP file that includes a folder structure and an XML "backbone" file, which provides metadata about content files and lifecycle instructions for the receiving system, to submit directly to the correspondent regulatory body (EMA, FDA, etc.).

Product Highlights
• Preconfigured security model with predefined roles
• Preconfigured governance model with predefined reports
• Full audit trail of all user actions in the application
• Manage full eCTD generation with high level and lower level folder structure
• EU Procedures Templates for Recognized Member States and Concerned Member States with/without folder structure
• Other Countries Procedures Templates with/without folder structure
• Automatic Agency Name recognition per country
• Automatic initial submission numbering and incremental updates with its sequence number
• XML "backbone" file providing metadata on the entire submission about content files and lifecycle instructions for the receiving system
• Stylesheets that support the presentation and navigation
• Associated document type definitions (DTDs)
• Enable collaboration with OpenText Blazon to PDF conversion

Value Proposition
• Multi device and multi access to increase and simplify user adoption and reduce training costs
• Unify dossier preparation processes within the organization, speeding-up regulatory audits and process failure identification
• Simplified maintenance with Business Users administration tools

STRATESYS TECHNOLOGY SOLUTIONS, SL

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