Kivo Features
Document Management (4)
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Dossier Management
Tracks submissions plans for products to report against milestones and progress. Streamlines the entire dossier lifecycle and tracks the status of all submissions.
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Tech Files
Supports the creation of technical files and essential principles checklists.
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Submission Planning
Provides templates and tools to create all planned regulatory content for a product.
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Archiving
Stores all previously submitted documents for use in audits or future submissions.
Sales (2)
Account Management
Supports management and planning of sales accounts
Sales Coaching
Facilitates the planning of calls, and records and generates reports on outbound calls
Product Management (3)
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Audit Trails
Enables traceability into the entire pre- and post-market lifecycle to monitor milestones, time to completion, and updates and approvals.
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Live Dashboards
Maintains up-to-date dashboards for overseeing every task, deadline, project status, and workflow.
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Collaborative Authoring
Allows multiple users to collaborate on documents and flag errors or updates.
Regulatory Affairs (2)
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Automated Notifications
Tracks key deadlines for submissions, renewals, and audits, and streamlines the document retrieval process for each activity.
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Communication Tools
Fields internal team and external agency messages or tickets related to regulatory concerns, and inboxes all correspondences.
Content Management (7)
Bulk Upload and Indexing
Allows users to upload multiple documents at once and provides dynamic indexing options.
Document Tracking
Manages the status of all trial documentation at all stages and flags missing documentation.
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Version Controlling
Tracks each version of a document and shows changes from each version or reupload.
Search Engine
Allows documents and metadata to be easily searched within the system.
File Planning and Milestones
Establishes study level, country level, and site level milestones and what amount of mandatory and optional documents need to be collected throughout the study lifecycle.
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Real-Time Authoring and Collaboration
Allows external or remote contributors to upload documents and work collaboratively in a controlled method.
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Content Workflows
Configures review, e-signature, and approval workflows for all documentation.
Operations (5)
Field Operations Management
Equips field sales teams with tools to better manage territories and report on field activities
Data Management
Collects and stores patient and company data in a centralized database
Multichannel Engagement
Analyzes and maintains patient-provider interactions across multiple touchpoints to optimize customer interactions
Task Automation
Automates and streamlines tasks, integrations, communication, and personalization
Industry Regulations
Ensures that sales teams, health care organizations, and field service reps adhere to industry regulations
Regulatory Compliance (4)
Dashboards and Reporting
Offers customizable dashboards and analytics to track completeness, compliance, quality, and timeliness of the study.
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TMF Reference Models
Offers a pre-built DIA TMF reference model hierarchy, and allows for configurable reference models to meet the specific needs of organizations and sponsors.
Inspection Readiness
Supports inspections and regulatory audits by maintaining inventory and document reports, and having pre-built compliance with all relevant regulatory guidelines.
Role Permissions
Designates customizable user roles and limit access to certain functions in the eTMF.
Quality Management (4)
Design Controls
Ensures that the product development process stays on track and continues to meet both user and vendor needs
Audit Management
Prepares for, plans, manages, schedules, and conducts internal and external audits
Supplier Network Management
Connects suppliers with product developers with consumers
Risk Management
Reviews, identifies, and assesses sources of risk in research and development
Additional Functionality (78)
AI Copilot
A virtual assistant that uses AI to pursue goals and complete tasks on behalf of users
Generative AI
Use AI to generate content in the form of text, images, videos, etc.
Search/Filter
Search and filter data across systems to locate required information by entering keywords or certain criteria
Corrective and Preventive Actions (CAPA)
Investigate and take action at root cause or error in processes to prevent recurring issues
Document Lifecycle Management
Series of processes that a document goes through from creation to archiving
Reminders
Timed notification for any upcoming task, deadline, appointment, or activity
Reporting & Statistics
Collection, analysis, and representation of numerical data and generation of reports to understand various patterns
Customizable Templates
Pre-designed layouts that can be customized to match preferences and requirements
Compliance Management
Track and manage adherence to policies for any service, product, process, or supplier
For Medical Purposes
Intended for medical use such as diagnosis, treatment, and consultation
For Legal Professionals
Specifically designed to address the needs of law firms and legal departments
Real-Time Notifications
Notifications that are delivered to users as soon as an event occurs
Risk Assessment
Initiate collection and analysis of known risks
Drag & Drop
Assemble applications and processes by dragging over and arranging pre-built components
Collaboration Tools
Provides a channel for team members to share media files, communicate, and work together
Workflow Management
Create, design and manage workflows for repetitive tasks
Activity Dashboard
Dashboard to view the status of ongoing processes, identify current incidents and track past activities
Quality Control
Ensure that quality requirements and standards are met across production processes
Archiving & Retention
Moving and separately storing data that is not actively used or continuous storage of data for compliance purposes
Approval Process Control
Manage the process of evaluating documents or requests submitted for approval
Secure Data Storage
Securely stores data to prevent data loss or breaches
Mobile Access
Access software remotely via mobile devices
Version Control
Track revisions and updates made to files and navigate between different versions
Task Management
Create, manage and track all task activities and progression
Indexing
Compile and organize data into specific metrics
Alerts/Notifications
Alerts or notifications of various types such as pop-up messages, sounds, banners, or badges
Activity Tracking
Track and document all activities across devices, networks, and other systems
Disaster Recovery
Plan and implement business continuity measures in case of unforeseen events
Multiple Format Support
Includes a variety of messaging formats including industry-specific (EDIFACT, HL7, X12)
Change Management
Track and monitor efficient handling of all changes/transitions
File Management
Create, save, and store files
File Sharing
Public or private sharing of digital files such as documents, audio/video, images, and more
Document Management
Store, manage, and track all electronic documents in a centralized location
Document Automation
Automated or logic-based workflows that assist in the creation of electronic documents
Third-Party Integrations
Set up connections to third-party platforms to improve business processes
Access Controls/Permissions
Define levels of authorization for access to specific files or systems
Data Import/Export
Import and export data to and from software applications
Audit Trail
A record of all activities within the system, including user access, changes made, etc.
Role-Based Permissions
Set & manage permission levels based on user roles and restrict access to only authorized individuals
Audit Management
Plan, schedule, and execute organization's accounts and assets to ensure compliance with policies and laws
API
Application programming interface that allows for integration with other systems/databases
Rules-Based Workflow
Automates and streamlines business processes by creating a sequence of predefined rules and actions that govern the flow of work
Electronic Signature
Digitally sign online documents
Document Review
Review and analyze existing information across documents
Full Text Search
Search for specific words or phrases within a document or database
Revision History
Track what was updated, who made the changes, compare two revisions, and revert or perform another revision
Real-Time Reporting
Active reporting of data and metrics
Forms Management
Store, manage and track all forms in a centralized location
Document Generation
Custom forms to streamline repetitious aspects of a document
SSL Security
Security protocol that ensures secure, encrypted communication over the internet, safeguarding sensitive data from unauthorized access
Content Management
Handles digital content throughout its lifecycle, from creation and storage to distribution and archiving
Access Expiration Management
Set rules for access to expire based on fixed dates, time elapsed, number of views, number of downloads etc.
Optical Character Recognition
Ability to recognize printed or written text within digital images or scanned documents
Document Classification
Assign categories, labels, tags, or attributes to documents for organization, search and storage
Metadata Extraction
Retrieval of embedded metadata that is present within a file
Commenting/Notes
Leave comments and notes on documents for others to view
Document Editing
Makes changes to document features such as text, fonts, formatting, etc.
File Recovery
Recover lost, deleted, or damaged files
Offline Access
Ability of websites, web applications, or mobile applications to function without an active internet connection
Annotations
Highlight content and/or make notations about parts of content
Compliance Tracking
Track and report regulatory data to either internal management or external stakeholders
Email Management
Manage, store and organize emails within the system or via third-party apps
Customizable Branding
Add customized logos and colors to align with company branding
Document Capture
Scan, move or upload electronic files within the software's repository
File Conversion
Convert files to a different format
Document Storage
Store and organize documents in a centralized system
Tagging
Attach digital tags to documents and assets for identification, search, or monitoring purposes
Automated Scheduling
Automatically create schedules based on business needs or employee availability and qualifications
Metadata Management
Collect and maintain structured information that describes data or content
Document Templates
Customizable sample documents that contain placeholder text or a standard layout that can be repeated for each new file
Autosave
The system automatically saves work on an interval without the user needing to manually save
For Engineering Documents
Training Management
Track employee/learner's progression through training programs
Version Rollback
The process of reverting to a previous version or state
Digital Signature
Electronic signing method that validates the authenticity and integrity of a digital document
Status Tracking
Track the status over time for a request, process, asset, or transaction
Version Comparison
The process of cross-checking new versions with previous copies to identify changes
Document Check-in/Check-out
Document Check-in/Check-out
Quality System (4)
Analytics & Reporting
Collects both vendor- and customer-facing data relevant to the product development lifecycle, and generates performance and health reports
Real-time Collaboration
Enables real-time collaboration like automated notifications and rich editing and commenting capabilities to minimize miscommunication
Document Control
Automates, centralizes, and archives documents and forms to create a single source of truth
Quality Processes
Automates and manages processes like CAPA (Corrective and Preventive Action) to monitor quality and complaints and promote transparency
Activity Management (5)
Product-To-Market Management
Accelerates time to market while reducing risk of medtech products and devices.
Regulatory Adherence
Ensures regulation compliance via notifications and triggers of noncompliant processes.
Information Management
Collects and manages product, operations, and activity information.
Process Automation
Automates the collection and management of data and business processes.
Sales Management
Optimizes the activities of field sales / medical representatives before, during, and after the sales cycle.
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