OpenText Collaborative Submissions

Coordinate the efforts of contributors and publishers, while managing every submission, at every stage, in every format, regardless of size

OpenText Collaborative Submissions (formerly Livelink ECM - Collaborative Submissions) is a comprehensive, collaborative environment for the authoring, review, approval, assembly, export, and long-term management of all regulatory documents and submissions. Combining a full document management feature set, rich metadata support, huge scalability, and a wide range of secure, collaborative business-process tools, OpenText Collaborative Submissions is the premier integrated submissions environment solution.

Features

The key features of OpenText Collaborative Submissions include:

• Combines document management and submission publishing: Collaborative Submissions is a unified solution that brings together document, forms and records management with submission publishing in a single, robust environment. Collaborative Submissions supports a wide range of business processes from ad hoc to tightly sequenced workflows, enabling full support for the lifecycle of completed submissions as well as all of their constituent documents and components.
• Manages all submission types: All regulatory submissions, of all sizes, formats and types can be managed in a unified environment at every stage in the development and approval process for each drug or device product.
• Applies a unified taxonomy: You can organize supporting documents according to predefined taxonomies, such as for the electronic Common Technical Document (eCTD) Document Type Definition (DTD), but extend these to match your internal needs and processes.
• Manages hyperlinks: All links between submission components are managed dynamically in Collaborative Submissions. Reports track the status of links, including version changes to the source and target documents. On export, the final hyperlinks are embedded within the documents.
• Creates previews: At anytime during the assembly process, you can create a Preview of a work-in-progress, to see what a completed submission will look like. You can export this preview to a file system.
• Freezes submissions: When the assembly and approval phases are finished, you can freeze the entire submission, locking it against further changes, then export the complete submission from Collaborative Submissions, generating all of the required XML.
• Automates business processes: Processes using workflow, electronic forms, and electronic signature capabilities improve productivity and ensure accuracy and auditability. Design electronic forms and workflows with easy-to-use, drag-and-drop design tools. Convert paper-based forms to electronic format and use them to initiate business processes.
• Provides role-based access controls: Tightly regulate access rights and permissions according to the roles of participants in the creation, assembly and publishing of submissions.
• Manages submission components: Manage the full lifecycle of component documents with services such as check-in/check-out, version history, event auditing, signing, and access control using permissions, alternate renditions and compound documents.
• Integrates with user workstations: Work with items in the OpenText ECM repository via menus and drag-and-drop directly from the Windows desktop in online or offline mode, using existing productivity tools such as Microsoft Office, Adobe Acrobat, Windows Explorer and WebDAV-compliant applications.
• Captures external content in assembled submissions: Collaborative Submissions can interface with other OpenText ECM-based instances, legacy document management systems, and file stores to access all components required for complete submission assembly.
• Applies records management to all content: Reduce risk by managing the entire lifecycle of all electronic and physical corporate records. Create record classification plans, manage retention periods and disposition policies, place holds on items scheduled for destruction, and manage the storage and circulation of physical records.