VALIDATE V5 IS HERE!

ENSURE THE INTEGRITY OF YOUR SUBMISSIONS

GlobalSubmit VALIDATE™ V5 is a comprehensive error analysis system designed to ensure the quality and integrity of submissions based on the eCTD format.  GlobalSubmit VALIDATE delivers powerful error analysis and quality checks of the structure of the eCTD format to ensure compliance with current ICH and global regulatory guidelines.

NEW WEB GRAPHICAL USER INTERFACE (GUI)

V5 features a new web GUI to facilitate easy navigation.  The new web interface delivers a fresh new look and feel as well as key feature that enable users to process multiple sequences and multiple submissions.  The web GUI presents users with the information they need to make effective decisions to ensure submission quality.  Click on the link below to view the new web GUI,

NEW SECURITY ADMINISTRATION

GlobalSubmit VALIDATE V5 provides an all-new administration module that provides the ability to establish user accounts and role-based security profiles.  The system supports Microsoft Active Directory authentication as well as GlobalSubmit's proprietary security model.  For a sneak preview, click the link below.

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REDESIGNED , ENHANCED VALIDATION REPORTS

GlobalSubmit VALIDATE™ V5 offers a new validation load status queue that allows users to see all jobs pending, error messages, processing dates, sequence, as well as submission and application types. The status queue provides an historical record of all processed, pending, or deleted submissions. V5 also includes a new Submission Report and Application Report. The Submission Report summarizes errors for each individual sequence within a submissions. The Application Report summarize errors across one or more sequences within an application.

MULTI-REGIONAL AND RPS SUPPORT

GlobalSubmit VALIDATE™ V5 supports submissions across multiple regions. As well as support for the next generation Regulated Product Submissions (RPS). In addition to CTDs, the system also extends new support for medical device 510k’s and other submission types.
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ADVANCED ENTERPRISE ARCHITECTURE

GlobalSubmit VALIDATE™ V5 includes a 3-tier architecture to support enterprise deployments. The foundation of V5 rests on an enterprise SQL database. V5 supports both Microsoft SQL and Oracle enterprise databases. V5’s mid-tier consists of advanced processing and error checking features that enable quality submissions across multiple geographies.