Life Sciences Regulatory Publishing Software Suite

Transcription

1 Easily manage submissions across multiple regions Solution Suite Overview

2 Life sciences companies today are challenged by regulatory submissions processes that vary by country and region. The DXC Technology Regulatory provides an end-to-end solution that empowers users to assemble, review, compile and publish dossiers such as electronic common technical documents (ectds) and non-ectd electronic submissions (NeeS) that meet various requirements. Our Regulatory is flexible, scalable and adaptable. With this solution, organizations can simultaneously publish and submit new drug applications in multiple markets and in compliance with a variety of regulatory formats. The solution increases the speed and efficiency of regulatory submissions and helps organizations deal with the challenge of working across disparate regulatory environments. Why choose DXC Regulatory Publishing Suite? As an integrated portfolio of market-leading products, DXC Regulatory Publishing Software Suite allows life sciences companies to easily manage regulatory submission documents across multiple countries and regions. The end-to-end solution lets users seamlessly assemble, review, compile and publish multicountry regulatory submissions. The DXC Regulatory Publishing Software Suite includes: ectdxpress: An ectd solution to create, assemble, review, compile, validate and track the life cycle of worldwide submissions Publisher: A report-level paper publishing and NeeS solution to build, review, publish and validate all regulatory documentation (paper, ectd and NeeS dossiers, legacy/rest of world submissions, clinical study reports and other generic reports) Virtual link manager (VLM): A robust virtual hypertext linking, bookmarking and annotation solution within ectdxpress and Publisher. VLM can also be deployed as a standalone solution. Integrated submission manager (ISM): An administrative application for managing metadata and control privileges, permissions, reports and access for individual users and groups for ectdxpress, Publisher and VLM Viewer: A nimble, easy-to-use webbased solution to view and ensure the quality of in-progress and archived ectd and NeeS dossiers, all in one place

3 Key benefits Simplified regulatory submissions DXC Regulatory has been designed to easily add new regions or countries and make updates to existing countries. Independent modules plug into core products, making it possible to add or upgrade modules with less testing and validation for the overall product. Global coverage Robust functionality supports the countryspecific submission requirements of the United States, members of the European Union (EU), Japan, Canada, Swiss Agency for Therapeutic Products (Swissmedic), Australia and Saudi Arabia, as well as emerging countries. The suite lets users create and life-cycle CTDs, generic, hybrid and report-style submissions to worldwide regulatory authorities. Capabilities include the ability to publish tables of contents, figures and appendixes specific to regional attributes at a report level. Preconfigured templates even let users view kanji titles across modules in Japan. Powerful metadata management DXC Regulatory Publishing Software Suite stores metadata in a centralized repository that can be seamlessly accessed and tracked during the life cycle of a compound. Users can view and sort in a single interface metadata (custom, document, study and region) in one submission or in related submissions. Real-time tracking and modification of metadata creates efficiencies in the submission process, significantly reducing the time required for ectd or paper assembly. Lower costs, increased flexibility Our Regulatory speeds time to market by shortening cycles, creating efficiencies and automating aspects of the submission process. The central platform minimizes disruptions to existing IT infrastructure and removes the need for software installation and maintenance. Modular components allow users to choose the solution and deployment model that best fits their needs. Manage submissions seamlessly with DXC Regulatory Publishing Software Suite Simplify the complexity of multicountry submissions Leverage the benefits of a single, integrated solution Increase the speed and efficiency of regulatory compliance Ease the rework involved in the publishing process Easily generate tables of contents, tables and figures Unleash powerful metadata management tools Achieve lower costs and improved flexibility

4 Key features Global standards compliance DXC Regulatory allows life sciences organizations to easily submit documents that meet varied requirements. Products automatically update and adjust file names based on regional requirements and submission formats. Submissions, such as ectd, paper or NeeS, done for one country can be cloned and edited for use in other countries, with a seamless transfer of data, links and formats from one submission to the next. Multiple submission capabilities DXC Regulatory helps organizations get products to market faster by reducing the need for rework. From one application, users can work on multiple submissions in either identical or different formats. Keyboard shortcuts, unique views and enhanced features can be used to clone, merge and republish documents in different formats. This helps automate and ease manual processes, such as reviews, data entry, bookmarking and hyperlinking. By installing all applications in the suite, organizations can process multiple submissions at the same time. Redundant data entry and costly errors are further eliminated through the direct import of submissions from one application to another. This increases automation in tasks such as populating the submission tree, renaming files, handling life-cycle operations and reconciling hyperlinks and bookmarks. Seamless integration All DXC Regulatory products are flexible and configurable, sharing a robust submission management tool, a backend database and a common user interface. System agents enable products to leverage shared functionality and integrate seamlessly. Built on Microsoft s.net central platform, products are interoperable with any other best-in-class system. User-friendly design Products in the DXC Regulatory share a common intuitive and user-friendly interface that has the look and feel of familiar desktop applications. The interface can be customized to suit individual preferences and regional settings. Products are closely integrated with document management systems such as SharePoint. For example, users can use SharePoint columns and content types to create efficiencies in the submissionbuilding process. Consistent publication templates With publication templates, organizations can save a substantial amount of time working on multiple submissions. In addition to publication settings, users can create templates that predefine publication structures and sections. Once a template has been created, Publishing will display the template in the virtual folder structure. Whenever a new publication is created, the user has the option of applying the template attributes to the new publication.

5 DXC s Regulatory Business Automation Software portfolio Our Regulatory is an integral component of DXC s Regulatory Business Automation Software portfolio, an end-to-end suite of products and services that covers the creation, review, approval, consumption and exchange of regulatory content for life sciences organizations. The DXC Regulatory Business Automation Software portfolio uses automation to simplify document creation and the submission process, creating efficiencies and shortening cycles. Organizations also benefit from DXC s global reach and vast experience in regulatory submissions, which helps guide companies through every step of the complex regulatory submissions process. Regulatory Business Automation Software Solution Portfolio components An application family providing integrated support for the end-to-end regulatory information-management process, including: Figure 1. DXC s Regulatory Business Automation Software portfolio providing integrated support for the end-to-end regulatory information management process Author and Approve FirstDoc/FirstPoint Writer Toolbox Virtual Link Manager (VLM) Plan, Track and Manage Tracker Build and Publish ectdxpress Publisher ToolBox Virtual Link Manager(VLM) Integrated Submission Manager (ISM) Archive FirstDoc/FirstPoint FirstDoc Exchange Learn more at life_sciences Access, View and Navigate Viewer About DXC Technology DXC Technology (DXC: NYSE) is the world s leading independent, end-to-end IT services company, helping clients harness the power of innovation to thrive on change. Created by the merger of CSC and the Enterprise Services business of Hewlett Packard Enterprise, DXC Technology serves nearly 6,000 private and public sector clients across 70 countries. The company s technology independence, global talent and extensive partner network combine to deliver powerful next-generation IT services and solutions. DXC Technology is recognized among the best corporate citizens globally. For more information, visit DXC Technology Company. All rights reserved. MD_6413a-18. August 2017