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How to Choose the Right Data Input Method

Our system is built around three main Worlds:

  • Product
  • Quality Management (QM)
  • Documents

Each world works with data in different ways. To manage and enter your data efficiently, it's important to understand the available input methods and when to use them.

Available Data Input Methods​

We offer four main ways to input data into the system:

1. Templates & Documents​

  • Used in: Document World
  • Best for: Creating structured documents like Technical Documentation, etc.
  • Key Features:
    • Reference product data (KUs/KTs)
    • Rendered into final documents (PDFs, etc.)
    • Can be included in a Submission

Use when: You are drafting formal documentation that needs to pull in product-specific data or global definitions.

2. Forms (Form-Templates & Form-Documents)​

  • Used in: Document World
  • Best for: Capturing structured, repeatable input (e.g., Complaint Forms, Audit Reports) mainly for the QM World
  • Key Features:
    • Add input fields to templates
    • Reference product data (KUs/KTs)
    • Designed for repeated use and data entry
    • Can generate records (e.g., one per complaint)

Use when: You need a document or template that collects input repeatedly, such as for operational processes or quality records.

3. Knowledge Units / Topics (KUs/KTs)​

  • Used in: Product World
  • Best for: Capturing and structuring product-specific data
  • Key Features:
    • Document technical, clinical, or regulatory data
    • Can be created as individual entries or grouped lists
    • Referenced by Templates, Documents, and Forms

Use when: You are entering or maintaining core product data, such as device descriptions, intended use, clinical evidence, etc.

4. Global Elements​

  • Used in: All Worlds
  • Best for: Data that is consistent across the platform
  • Key Features:
    • Globally referenceable (e.g., Glossary terms, company addresses)
    • Defined once, reused system-wide

Use when: The data is not product-specific and should be standardized across the entire system.

Putting It All Together​

Here’s a quick guide to help you choose:

GoalRecommended Input Method
Create a final documentTemplate / Document
Collect data via a form mainly for QMSForm
Capture product-specific structured dataKU / KT
Define reusable system-wide elementsGlobal Element

Example Scenarios​

  • Technical Documentation for a product:
    Use a Template that references KUs/KTs for data like intended use and performance characteristics.

  • Customer Complaint Process:
    Use a Form Template that records individual complaints, possibly referencing for example the product name.

  • Glossary of Terms:
    Use Global Elements to define terms once and reuse across multiple documents and templates.