Required Roles: Quality user or administrator
Required Permissions: Access to Quality Activities
Quality Activities provide a centralized way to manage, track, and report on quality events such as deviations, CAPAs, change controls, risk assessments, inspections, audits, and more. They combine configurable metadata with controlled documents to create a complete, traceable quality record.
Overview
Quality Activities are built on two core Kivo capabilities:
Controlled Documents store and manage the documents associated with an activity, including forms, procedures, and supporting documentation.
Activities capture the metadata used to track, trend, and report on quality events.
Together, these features provide a complete record of both the documentation and the structured data associated with a quality process.
Note: The same underlying functionality is used throughout Kivo. While this article focuses on Quality Activities, Regulatory Activities and Clinical Sites follow the same core concepts with different terminology.
Creating a Quality Activity
To create a new activity:
Navigate to Quality Activities.
Click on 'Create Quality Activity'.
Select the appropriate activity subtype (for example, Deviation or CAPA).
Enter the required information.
Create the activity.
Each activity contains configurable metadata that can be tailored to your organization's processes during implementation. Examples of metadata include:
Status
Classification
Dates
Root cause
Risk information
Custom text fields
Single-select and multi-select lists
Administrators can also designate fields as required before users can continue through the process.
Linking an Activity to Controlled Documents
Once an activity is created, it can be linked to your Controlled Documents cabinet.
Adding an activity to a cabinet automatically:
Creates the appropriate folder structure if needed
Organizes documents according to your document hierarchy
Associates all future documents with the activity
The folder naming convention and structure are fully configurable.
Generating Documents
After an activity has been linked to a cabinet, users can generate documents directly from predefined templates. Templates can include:
Deviation forms
CAPA forms
Investigation reports
Effectiveness check forms
Any other Word-based template used by your organization
Multiple templates can be available for a single activity type, depending on your business process.
Automatically Populating Forms
Metadata entered on the activity can automatically populate fields within generated document templates. For example:
Activity number
Title
Dates
Classification
Owner
Other configured metadata
This reduces duplicate data entry while ensuring consistency between the activity record and its associated documentation.
Completing the Document Workflow
Generated documents follow the standard Controlled Documents workflow. Users can:
Collaborate on documents
Review and approve changes
Use Track Changes
Save document versions
Maintain a complete audit trail
Electronically sign completed documents
Once approved, documents become part of the permanent activity record.
Updating Activity Metadata
After documents are completed, activity metadata can be updated as needed. Common updates include:
Closing the activity
Recording completion dates
Updating status
Capturing final classifications
Recording additional reporting information
This ensures reporting remains accurate throughout the lifecycle of the activity.
Reporting
Quality Activity metadata powers reporting throughout Kivo. Organizations can generate reports to:
Track open and closed activities
Trend deviations and CAPAs
Analyze classifications and root causes
Export metadata for additional analysis
Monitor quality system performance
The activity list also provides a configurable, filterable view of key information for day-to-day tracking.
Related Activities
Quality Activities can be related to one another. For example, a deviation may identify a systemic issue that requires a CAPA. Rather than creating a new activity from scratch, users can create a Related Activity.
Kivo automatically carries forward relevant information from the original activity, helping reduce duplicate data entry while maintaining traceability between related quality events.
Common relationships include:
Deviation to CAPA
Deviation to Change Control
Deviation to Risk Assessment
Each related activity maintains its own metadata, documents, workflow, and audit trail while preserving links back to the originating activity.
Configuration
Quality Activities are highly configurable. During implementation, administrators can configure:
Activity types
Metadata fields
Required fields
Templates
Folder structures
Naming conventions
Reporting fields
Labels and terminology
This allows Kivo to align with your organization's existing quality processes while using the same validated underlying functionality.