Guide: When to Put Data Where
CertHub separates list information into four distinct modules: Global Elements, Data Collections, Single Product Data Lists, and QM Lists. Each type serves a different purpose and ensures consistent, reusable, and well-structured data. This guide explains when to place data in which module and provides a checklist to help you decide.
Lists - where to maintain them?
1. Global Elements
Use Global Elements when the information…
- is not product-specific and not process-specific.
- is not part of a specific Technical Documentation (TD) file.
- does not originate from a QMS form or record.
- represents stable organizational knowledge.
- is independent of any product variants or configurations.
- describes company-wide standards, terminology, or definitions.
Example: Company Address, Glossary, Requirements
2. Data Collections
Use Data Collections when the information…
- is relevant to multiple products.
- needs central maintenance across multiple Products.
- should allow each product to select a subset of the items.
- represents cross-product lists.
- does not come from a QMS form.
- is reusable for current and future products.
- enables product teams to reuse entries without recreating them.
Example: Manufacturing Sites across Varaints, Supplier List
3. Multi KTs
Use Multi KTs (Data Lists for a single product) when the information…
- applies only to a single product.
- is not reused across other products and thus does not nedd central maintenance.
- does not originate from a QMS process or record.
- captures unique details of a single product
Example: Installing Instructions, Functional Elements
4. QM Lists
Use QM Lists when the information…
- is created through a QMS form submission.
- results in an auditable QMS record (ISO 13485 / MDR).
- belongs to a QMS process (CAPA, Supplier Evaluation, Training, Audit, etc.).
- is not part of any product's technical file.
- represents operational quality management data, not product attributes.
- is maintained or updated only through form-based workflows.
- is part of a controlled QMS activity (e.g., deviations, approvals, changes).
- always creates traceable, record-based evidence.
Example: List of all Complaints starting from January 2025 for Product Sterilizer 20A
It is a company decision, whether to maintain Product data in a Data Collection (Master List) versus under a single Product.
In theory, all Multi KTs under a single Product can be modeled as a Data Collection and vice versa.
Both versions might make sense depending on your case.
Generally, if you only have 1 Product, you would not use Data Collections!
Not a List?
If your data is not a list, determine whether it is Product Information, External Data, or QM Records.
Product Information - a single field
Use single KTs (Product Information) when the information…
- is product-specific information (e.g., Intended Use, product attributes).
- belongs to a single product only.
- should be stored in a Knowledge Template (KT).
- might also belong in Product Properties (check there first).
Example: Intended Use, Risk Class (Product Properties), etc.
External Data
Use External Data when the information…
- is an external file (e.g., images, PDFs, .docx files).
- does not need to be maintained on a data level within CertHub.
- belongs to a specific object (e.g., Process, Document, or Submission) — attach it directly to that object.
Example: Product images, PDF attachments, legacy documentation
QM Records
Use QM Records when the information…
- needs to be maintained and created as QM records.
- should be created through Form Templates (templates with input fields to fill out).
- will result in QM Lists (a compact view of all filled-out forms from the same Form Template).
Example: Complaint Records (based on the Complaint Form Template), CAPA Records, Audit Records
QM Lists are a compact view of all records that originate from the same Form.
For example, "All Complaint Records" is a QM List based on the Complaint Form Template.