Required Roles: Editors/Reviewers/Viewers (to use structures)
Required Permissions: Workspace Manager for configuration. Access to the relevant cabinets and folders in Regulatory, Clinical, and/or Quality modules
Overview
Kivo organizes documents using a combination of cabinets and folders. This structure is designed to support the way Quality, Regulatory, and Clinical teams think about their documentation. Whether that’s controlled documents, submissions, eTMF, site files, or vendor records.
A well-designed cabinet and folder hierarchy:
Makes it easy to visualize your documentation structure.
Ensures documents are filed in the correct context.
Improves metadata consistency by tying document types and fields to where documents live.
Supports compliance and audit readiness by aligning with your SOPs, TMF, and regulatory expectations.
This article explains how cabinets and folders work in Kivo, how they can be tailored for Quality, Regulatory, and Clinical teams, and how to design a structure that scales as your organization grows.
How Kivo Organizes Content
In Kivo, your documentation is organized into a hierarchy:
Cabinets are the top-level containers (for example, “Quality Controlled Documents,” “Regulatory Submissions,” “Clinical eTMF”).
Folders and subfolders live inside cabinets and reflect how you group documents in daily work (for example, by process, department, product, study, or site).
This hierarchy is visible in the Kivo interface, helping users:
Understand where they are in the system at a glance.
Navigate quickly to the content they need.
See which documents and placeholders belong to each process or project.
Behind the scenes, cabinets and folders also connect to:
Document types, categories, and artifacts (for numbering and naming).
Metadata configurations (which fields appear on documents).
Workflows (how documents move through draft, review, and approval).
By carefully designing your cabinets and folders, you create a strong foundation for consistent document management across Quality, Regulatory, and Clinical teams.
Cabinets & Folders for Quality, Regulatory & Clinical
While every organization is different, most Kivo workspaces use cabinets and folders to mirror standard regulated content areas:
Quality (Controlled Documents & Vendors)
For Quality teams, cabinets often focus on Controlled Documents and Vendors. For example:
Cabinet: Quality Controlled Documents
Folders by process (e.g., “QMS,” “Manufacturing,” “Pharmacovigilance”).
Subfolders for document families (e.g., “SOPs,” “Policies,” “Work Instructions,” “Forms”).
Cabinet: Vendors
Folders by vendor type (e.g., CROs, Labs, CMOs).
Subfolders for qualifications, audits, and vendor-specific controlled documents.
This structure helps Quality teams:
Quickly locate controlled documents by process or department.
Align document organization with SOP categories and QMS requirements.
Keep vendor-related documents grouped and easy to review during audits.
Regulatory (Submissions & Activities)
Regulatory teams often group content around submissions and regulatory activities, such as:
Cabinet: Regulatory Submissions
Folders by product or program.
Subfolders by submission type or region (e.g., IND, NDA/MAA, variations, annual reports).
Cabinet: Regulatory Activities
Folders for health authority interactions, commitments, and response packages.
Subfolders for correspondence, meeting minutes, briefing books, and follow-up letters.
This approach:
Aligns the digital structure with your regulatory strategy and health authority interactions.
Makes it easier to see all documents linked to a specific product, indication, or submission.
Supports metadata-driven reporting on submission status, health authority, and region.
Clinical (eTMF & Site Management)
Clinical teams often use cabinets and folders to mirror eTMF and site structures, for example:
Cabinet: eTMF / Clinical TMF
Folders by study or protocol.
Subfolders aligned to your TMF structure (e.g., sections, zones, or artifact groups).
Cabinet: Site Management
Folders by site or region.
Subfolders for investigator documents, contracts, ethics/IRB documents, and site communications.
This helps Clinical teams:
Visualize the eTMF structure and quickly see where documents belong.
Keep site-level documentation clearly separated but still tied to studies.
Use metadata and folder-level configuration to enforce the correct document types per artifact or section.
Automated Folders & Reusable Structures
One of the most powerful features of cabinets and folders in Kivo is the ability to define Automated Folders. Automated folders let you re-use a standard folder structure whenever you create a new product, study, or site, for example:
A reusable SOP/Policy/WI structure for each department.
A standard TMF folder tree for every new study.
A consistent set of site folders (regulatory, contracts, ethics, logs) for each new site.
Instead of creating folders one by one, you:
Define your preferred structure in the Cabinet Folder Structure Template (.xlsx).
Mark which folders should be included in an automated folder template.
Upload the configuration so Kivo can create and reuse that structure whenever it’s needed.
This is particularly helpful for:
Scaling up quickly as new products, studies, or sites are added.
Maintaining consistent organization across programs.
Reducing manual setup effort and the risk of missing folders.
Aligning Folders with Document Types & Metadata
Cabinets and folders do more than just hold files—they also drive document types, numbering, and metadata.
Workspace Managers can configure:
Which document types, categories, and artifacts are expected in each folder.
How control numbers (prefixes and sequences) are generated for documents in that folder.
Which metadata fields appear, based on the document type and folder context.
For example:
A Quality SOP folder may automatically assign an SOP document type with a “SOP-#{{Dept}}-#{{####}}” numbering format.
A TMF artifact folder may automatically assign the correct artifact and associated metadata fields.
A Regulatory response folder may enforce metadata for health authority, submission type, and region.
This alignment ensures:
Documents are consistently named and numbered.
Teams see only the relevant metadata fields for their work.
Reporting and dashboards accurately reflect your real-world structure and regulatory obligations.
Best Practices for Designing Your Hierarchy
When setting up cabinets and folders for Quality, Regulatory, and Clinical teams, consider the following best practices:
Start from your current structure. Use your existing file share, SOP index, TMF structure, or submission plan as a starting point so the hierarchy feels familiar.
Design for scalability. Plan how you will add new products, studies, or sites. Use automated folders for any structure you expect to repeat.
Keep navigation intuitive. Name cabinets and folders in plain language (e.g., “Clinical eTMF” instead of overly technical codes) so new users can find content easily.
Align with document types and metadata early. Decide which document types and metadata fields belong to each area before you start creating large numbers of documents.
Use groups and permissions wisely. Pair your folder structure with appropriate group-based access so users only see the cabinets and folders that are relevant to their role.
Document your structure. Create a simple internal guide or diagram that explains your cabinet and folder hierarchy and share it with stakeholders across Quality, Regulatory, and Clinical teams.
Getting the structure right at the beginning makes it easier to maintain compliance, support audits, and keep your teams aligned as Kivo usage grows.