eDOCSmanager Powered by CARA - EXTEDO's Document Management Solution for Life Sciences

This video provides an in-depth exploration of eDOCSmanager, EXTEDO's document and content management solution specifically designed for the life sciences industry. The presentation begins by establishing the critical need for accuracy, consistency, efficiency, and quality in all business processes involved in developing highly complex and regulated products within this sector. eDOCSmanager is introduced as a comprehensive solution integrated within the EXTEDOpulse platform, addressing document management needs across clinical, quality, SOP, and regulatory tasks, with the flexibility to support both local installations and cloud solutions based on company policy.

The video then delves into the user-friendly and intuitive interface of eDOCSmanager, designed to facilitate easy organization, collaboration, and review of content and documents online. It highlights key interface elements such as the main menu button, context-sensitive toolbar buttons that adapt to user permissions, and user profiles for setting preferred channels and languages for notifications about document changes and workflow tasks. The modular design is showcased through the "regulatory module," where views are tailored to specific document types, allowing users to navigate between modules based on their permissions. The navigation panel on the left provides access to folders, while the central main view panel lists selected documents, offering customizable sort orders and displayed properties.

A significant portion of the video focuses on addressing the challenging task of finding data within complex document repositories. eDOCSmanager tackles this by enabling property-based navigation, allowing users to group documents into folders based on various dimensions like domain, group, product, and market. Beyond structured navigation, the solution offers features like document subscriptions for update notifications, shared tags for collaboration, and shortcuts to frequently accessed items, including "Last Action items" and "last 100 items accessed." Property filters further refine displayed document lists, exemplified by filtering for documents prepared for the US that are not yet part of a submission, with the option to graphically display results. Content creation is also streamlined, offering options to create placeholders, quickly generate documents using pre-made forms and templates, and integrate specialized templates like EXTEDO eCTD, ensuring only relevant templates are displayed to the user.

Finally, the video emphasizes eDOCSmanager's robust workflow capabilities and its role in ensuring regulatory compliance. After authoring content, users can send it through a defined workflow for review or approval, with the flexibility to specify recipients, their sequence, and whether tasks require completion by one or all. Documents transition between life cycle states either automatically upon task completion or manually. The presentation concludes by highlighting EXTEDO's extensive experience of over 20 years and its trusted position as a vendor for more than 35 regulatory authorities worldwide. This deep industry and authority experience has culminated in a solution that is easy to use, provides a comprehensive content management environment, and ensures rapid compliance with the latest global regulatory changes.

Key Takeaways:

• Unified Document Management for Life Sciences: eDOCSmanager serves as a comprehensive document and content management solution specifically tailored for clinical, quality, SOP, and regulatory tasks within the life sciences industry, consolidating diverse documentation needs into a single platform.
• Regulatory Compliance at Core: The solution is engineered to meet the demanding needs of life sciences companies, ensuring rapid compliance with global regulatory changes, a critical aspect given EXTEDO's experience with over 35 regulatory authorities.
• Flexible Deployment and Configuration: It supports both local installations and cloud solutions, offering high configurability to allow easy and incremental adjustments to business processes to match specific organizational needs and regulatory requirements.
• Enhanced Collaboration Features: The platform facilitates online collaboration and review of documents, incorporating built-in electronic signatures and integrations with external services like Adobe Sign and DocuSign for streamlined approval processes.
• Intuitive User Interface: A user-friendly interface with context-sensitive toolbar buttons, customizable views, and personalized settings (e.g., preferred language, notification channels) aims to improve user efficiency and reduce the learning curve.
• Advanced Document Discovery and Navigation: Addresses the challenge of finding data through property-based navigation, allowing documents to be grouped and filtered by dimensions such as domain, product, and market, significantly improving searchability.
• Proactive Information Management: Users can subscribe to documents for change notifications, create shared tags for team organization, and utilize shortcuts to frequently accessed items, enhancing proactive document management.
• Streamlined Content Creation: Offers various options for content creation, including placeholders, pre-made forms, and templates, with specific integration for EXTEDO eCTD templates to ensure quick access to relevant departmental templates.
• Robust Workflow Management: Provides flexible workflow definition for review and approval processes, allowing administrators to specify recipients, their sequence, and the conditions for task completion, supporting both automatic and manual life cycle state transitions.
• Centralized Data Access and Traceability: As part of the EXTEDOpulse platform, eDOCSmanager enables access to all data and documents through a common interface, promoting seamless collaboration, discovery, and traceability across an organization by eliminating disparate repositories.
• Detailed Document Information: Widgets provide detailed information about documents, including version history and relations with other documents or activities, enhancing context and understanding of interconnected information.

Tools/Resources Mentioned:

• EXTEDOpulse platform
• Adobe Sign
• DocuSign
• EXTEDO eCTD templates

Key Concepts:

• Document Management Solution (DMS): A system used to store, manage, and track electronic documents and electronic images of paper-based information.
• Content Management Solution (CMS): A system used to manage the creation and modification of digital content.
• Electronic Signatures: Digital representations of a signature used to authenticate a document or data, often critical for regulatory compliance (e.g., 21 CFR Part 11).
• Workflow Management: The automation of business processes, in this context, specifically for document review, approval, and life cycle transitions.
• Regulatory Compliance: Adherence to laws, regulations, guidelines, and specifications relevant to the life sciences industry (e.g., FDA, EMA, GxP, 21 CFR Part 11).