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Understanding Use Cases in CertHub

In medical device development, maintaining traceability between different types of documentation is crucial for regulatory compliance. Our system introduces Use Cases as an intuitive way to manage these relationships between the records of correlated topics. This allows you to create specific, contextual links between related documents - for example, linking all risk records associated with a particular product.

What Are Use Cases?​

Use Cases in CertHub define structured workflows for Domain Objects, including:

  • Products and their
  • Knowledge Units (KU) / Knowledge Topics (KT)
  • Standard Operating Procedures (SOPs)
  • Templates/Documents
  • (Optional) Submission Module

A Use Case represents a complete workflow within CertHub for a specific regulatory area, such as Risk Management or Requirements Engineering.

Predefined Use Cases​

Currently, CertHub supports two predefined Use Cases:

  1. Risk Management
  2. Requirements Engineering

These predefined configurations establish the structure and relationships between KUs, KTs, SOPs, and related documents, ensuring consistency and compliance.

How to Start​

  1. Creating a Product:

    • For any certification process, we need to define which product it is for.

  2. Defining Knowledge Units & Topics (KU/KT):

    • The foundation of a Use Case is built by filling relevant KUs and KTs for a specific product. The structure of the KU/KTs is provided in the use case through KU/KT schemas.

  3. Standard Operating Procedures (SOPs):

    • SOPs are the structured process included in a Use Case.
    • They link to necessary Domain Objects, including:
      • KU/KTs
      • Forms
      • Work Instructions
      • Templates
      • Documents

  4. Templates & Document Creation:

    • Templates serve as reusable patterns, pre-structured for specific Use Cases.
    • These templates are filled with relevant data references (Product, Form, SOP, Work Instruction).
    • Documents created from templates can be included in Submissions, if required.

Why Use Cases?​

By structuring workflows in CertHub, Use Cases ensure:
✅ Standardization of processes
✅ Consistency in documentation
✅ Traceability for certification requirements
✅ Efficiency in regulatory compliance

CertHub’s predefined Use Cases provide a clear path for managing documentation and regulatory requirements effectively. 🚀

How Use Cases Work on Knowledge Topics​

When you open any Knowledge Topic that's part of a Use Case, you'll see the Use Case Status panel at the top of your screen. This serves as your central control point for managing relationships between different types of documentation. Use Cases are automatically activated when you implement the associated Library.

Use Case Status Panel
The Use Case Status panel displays a complete configuration with a green status indicator. The panel shows the current state of your documentation setup, with all required topics properly configured and linked.

Status Indicators and Feedback​

The status panel provides immediate visual feedback on your configuration:

  • ✅ Green status – All required topics are properly configured and linked
  • ⚠️ Yellow status – System detected missing or duplicate topics that need attention
  • 🔍 Expandable sections – Provide detailed information about required topics and their current status

Use Cases ensure that you have exactly one instance of each required topic - no more, no less. This precision is crucial because the system needs to know exactly which topics to link together. When topics are missing or duplicated, the Use Case will display error messages to guide you toward proper configuration.

Detailed Topic Overview​

Clicking the expand arrow reveals a comprehensive breakdown of your topic configuration:

  • 📌 Topics currently available in your system
  • ❌ Missing topics that need to be created
  • 🔄 Duplicate topics that require consolidation

Expanded Use Case Status Panel
The expanded status panel provides a detailed breakdown of your topic configuration. In this example, the panel highlights one missing topic and one duplicate topic that needs resolution. The Use Case will remain inactive until these issues are addressed, as proper tracing requires a complete and unambiguous topic structure.

Creating Relationships​

When you create a new record within any Use Case-enabled Knowledge Topic, you'll find the Domain-Specific Tracing section in the record drawer. This is where you establish relationships with other records after initial creation.

Domain-Specific Tracing Overview
The Domain-Specific Tracing overview shows the available connection points between different types of documentation, providing a clear structure for establishing regulatory-compliant relationships.

Domain-Specific Tracing Details
The Domain-Specific Tracing section in the record drawer displays detailed options for creating relationships between documents. Each relationship type comes with a clear description of its purpose and regulatory significance.

Each relationship option is accompanied by a clear description of its purpose, ensuring you make appropriate connections that satisfy regulatory requirements.

warning

The selected trace relationship maps to the respective KT and its name. In order to specify a custom name for a KT, it needs to have a field with the key "name". Additional fields in use cases need the key conststing of the name connected by '_' in the respective form, e.g. "Probability of Occurence" needs the key "Probability_of_Occurence".

Keys in Forms

Further Information​

Please look at the Risk Management Use Case or the Requirements Use Case case for further Information on the respective KU/KTs with their relationships, SOPs and the necessary Templates/Documents.