Security & User Management
Attribute Based Access Control system, providing the configurability of user roles and creation of teams comprising of one or more roles.
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Dashboards & Reports
Configurable and actionable dashboards, where users can navigate from the higher-level functional area to the documents and related components.
Microsoft Word templates can be configured and bound to the information model and metadata models to support the document types in the platform.
In regulated industries, information is the source of innovation, and many content and information sources feed the research and product development pipeline. The ability to create, share, reuse, navigate, find, and protect essential information is critical to getting products approved by regulators, and launched. […]
Generate documents by re-using content from one or more existing documents based on reuse policies configured in the information models.
Change Impact Assessment
Component reuse reports are available to determine where content is used/reused, and to help assess impacts of change across the system.
Information Model Management
Define the structure and policies and associated metadata for any type of information managed in the platform.
Supports the capability to preconfigure one or more templates that can be used to generate multiple outputs or variants simultaneously.
Provide configurable lifecycles for documents and components and support the routing of components or documents for collaborative review-approval.
Anonymization & Redaction
Comply with EMEA Policy 70 requirements for anonymization and publications of personally identifiable information from Clinical data sets.
Authors and reviewers can collaborate in real time and work with the entire document in their familiar user interface, Microsoft Word.
Provides the capability to configure and create content libraries for specific needs and components within the libraries made available to authors.
Integrations to external systems and repositories with the platform are implemented using an Integration Framework, using modern RESTful APIs.