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Managing Schemas and Libraries

Schemas and Schema Libraries form the foundation of your product data management in CertHub. They define the structure and validation rules for your product data, ensuring consistency and regulatory compliance across your product portfolio.

Understanding Schema Libraries​

Schema Libraries group related schemas together based on regulatory or business needs. This organization helps maintain a clear structure and enables efficient schema management.

Library Overview The Schema Library interface shows how schemas are organized by Use Case, allowing multiple schemas to belong to multiple libraries for maximum flexibility.

Library Organization​

Libraries can be organized by:

  • Regulatory frameworks (MDR, IVDR, FDA)
  • Quality system aspects (Design Controls, Risk Management)
  • Business processes (Manufacturing, Clinical Evaluation)
  • Product categories (Software, Hardware, Combination Products)

Use Cases​

Some libraries belong to specific Use Cases which activate special features:

  • Risk Management: Enables automatic risk tracing
  • Clinical Evaluation: Activates clinical data tracking
  • Design Controls: Links to design review workflows
  • Technical Documentation: Connects to regulatory submissions

Working with Schemas​

Schemas define the template structure for Knowledge Units and Topics in your products. Importantly, schemas mirror the exact structure you'll see in products, making them intuitive to work with.

Schema Structure​

The schema interface follows the same hierarchical structure as products:

  1. Knowledge Unit Schemas: Like Knowledge Units in products
  2. Knowledge Topic Templates: Like Topics in products
  3. Form Editor: The same form editor used in products, but for creating templates

This mirroring means that:

  • If you're familiar with products, you already know how to work with schemas
  • What you define in the schema is exactly what users will see in products
  • The form editor works the same way, just in "template mode"

Creating Schema Templates​

When creating a schema template:

  1. Create Knowledge Unit Schemas (just like KUs in products)
  2. Define Knowledge Topic Templates using the form editor
  3. Configure fields, validation rules, and relationships
  4. Preview how it will look in products
Understanding the Mirror Structure

Think of schemas as "product templates":

  • Knowledge Unit Schemas → become Knowledge Units
  • Knowledge Topic Templates → become Knowledge Topics
  • Form configurations → become actual data entry forms

Schema Overview The Schema interface provides a complete overview of all available schemas, their relationships, and usage across your organization. Notice how it mirrors the product interface.

Schema Types​

  1. Standard Schemas

    • Define basic data structures
    • Can be used across multiple libraries
    • Support inheritance and extension
    • Enable data reuse

  2. Use Case Schemas

    • Tied to specific regulatory requirements
    • Include pre-configured validation rules
    • Enable special tracing features
    • Support automated compliance checks

Import and Export​

Schemas support comprehensive import/export capabilities:

Importing Schemas​

  • JSON format support
  • Bulk import capabilities
  • Validation during import
  • Relationship preservation

Exporting Schemas​

  • Complete schema definitions
  • Configuration settings
  • Relationship information
  • Use case associations

For detailed information about importing and exporting schemas, see the Import & Export Guide.

Video Tutorials​

Managing Schema Libraries​