Bring information together in one location with Viewer to view both archived dossiers and current eCTDs.
Information access sometimes presents challenges for the life sciences industry, but having data immediately available and in one location can be invaluable during the regulatory submission process. For example, information from archived dossiers might well be helpful in the handling of in-process electronic Common Technical Documents (eCTDs) or in addressing agency queries.
DXC's Viewer tool brings all of that information together in one location for viewing both archived dossiers and current eCTDs. Furthermore, Viewer does it without the cost of additional submission-building tool licenses or the need to train employees on those tools.
With Viewer, companies are assured that their repositories remain secure for the viewing of eCTDs, non-eCTD electronic submissions and hybrid or volumized PDF-based dossiers and related correspondence.
A Web-based tool, Viewer requires only a browser and a PDF viewer. Plus, it’s as easy to install as it is to use. Viewer lets users:
- Search or filter a dossier list: The dossier list gives access to all archived submissions and, when integrated with eCTDXPress, all in-progress eCTDs. The list itself has filtering capabilities on each column of data, and favorites can be identified with one click — a feature that gives quick access to repeatedly accessed dossiers. In addition, an independent set of search fields is provided, as is the ability to sort the list.
- View dossiers: Double-clicking on a listed dossier gives a view of its structure, content and metadata. With an eCTD, several life-cycle viewing options are available, including single, cumulative, current and regulatory-action views. Metadata views group together similar metadata in a single folder, or they can separate each for viewing of a repeating folder for each piece of metadata. To open a document or documents, users simply select one or more from the submission outline and then double-click to view. The documents’ electronic navigation is fully functional via bookmarks and hyperlinks, including cross-document links.
- Open correspondence: When correspondence folders are identified, the content of those folders is also identified in the dossier view. Therefore, correspondence documents can be opened as reference information while a viewer is inside the dossier.