Traceability

In CertHub, no object exists in isolation. Every item - whether it's a SOP, document, record, or template - is part of an interconnected network of relationships. This approach reflects the reality of quality management systems where changes in one area often impact multiple related items.

Benefits of Traceability

CertHub's traceability features provide key advantages for medical device companies:

1. Impact Analysis

   • Instantly identify affected items when changes occur
   • Understand the full scope of modifications needed
   • Prevent unintended consequences of changes
   • Maintain system consistency across updates

2. Compliance Support

   • Demonstrate clear relationships between requirements and implementation
   • Support audit trails with version-specific traces
   • Maintain regulatory compliance evidence
   • Simplify regulatory submissions with complete traceability chains

3. Quality Management

   • Track relationships between quality system elements
   • Ensure comprehensive change management
   • Support investigation and CAPA processes
   • Maintain data integrity across your quality system

4. Efficiency and Risk Reduction

   • Reduce manual tracking effort
   • Minimize documentation errors
   • Speed up impact assessments
   • Streamline audit preparations

Understanding Object Relationships

Each object in CertHub is uniquely identified by three key attributes:

• Entity Type (e.g., SOP, Document, Template)
• Unique ID
• Version

This means that traces not only connect objects but also maintain version-specific relationships, ensuring that you can track how items were connected at any point in time.

Supported Entity Types

CertHub supports tracing between the following entity types:

Entity Type	Description
SOP	Standard Operating Procedures
WorkInstruction	Detailed step-by-step instructions
Form	Data collection templates
Product	Product information and specifications
KnowledgeUnit	Individual pieces of knowledge
KnowledgeTopic	Organizational units for knowledge
Document	General documentation
Template	Reusable document templates
Record	Completed forms and historical data
File	Uploaded files and attachments
KUSchema	Knowledge Unit Schemas
KTSchema	Knowledge Topic Schemas
Submission	Regulatory submissions

note

The availability of entity types may vary depending on your system configuration and the context where the Tracer is being used. For example, when viewing an SOP with dedicated template linking tabs, the Tracer might only allow template connections.

Relationship Types

Relationships between objects are directed links with specific meanings. Currently supported relationship types include:

• "Is Related To"
• "Mentions"
• "Is Mentioned By"
• "Is Parent Of"
• "Has Parent"
• "Contributes To"

note

The available relationship types may be updated as the system evolves to better support different use cases.

Creating Relationships

Manual Traces

For creating manual traces, you use the Tracer component which is available in the Traces Tab of any supported object. When creating a trace, you:

1. Select the target object
2. Choose the relationship type
3. Optionally set up bidirectional relationships (so that the target object can trace back to the source object)

Automatic Traces

CertHub's automatic tracing system creates and maintains relationships between objects without requiring manual intervention. This system ensures that the relationships between objects accurately reflect their actual usage and dependencies throughout the platform.

Sources of Automatic Traces

The system automatically creates traces from several sources:

1. Template-Based Documents When a document is created from a template, a trace is automatically established:

   This trace ensures that if the template changes, you can identify all documents created from it.

2. Schema-Based Knowledge Units and Topics When a Knowledge Unit or Knowledge Topic is created from a schema, a trace is automatically established:

   This allows you to track which schema was used to create specific knowledge units or topics, ensuring consistency and facilitating impact analysis when schemas change.

3. Text Editor References When you reference an object (like a product) in the text editor, a trace is created:

   This allows you to track where specific objects are mentioned across your documentation.

4. Process Editor References The Process Editor creates automatic traces whenever you assign objects to process elements and save your changes:

   This ensures that the visual representation in process diagrams always matches the actual data relationships.

How Automatic Traces Work

Automatic traces function through a sophisticated system that:

1. Monitors Object Interactions

   • Detects when objects are referenced or linked in various contexts
   • Identifies the appropriate relationship type based on the interaction context
   • Creates traces with the correct directionality

2. Maintains Bidirectional Relationships

   • Creates corresponding backward traces when appropriate
   • Ensures objects can "see" where they are being used
   • Maintains relationship integrity in both directions

3. Manages Trace Lifecycle

   • Automatically adds traces when new references are created
   • Automatically removes traces when references are deleted
   • Prevents duplicate traces when the same reference appears multiple times
   • Updates traces when referenced objects change versions

Visual Differentiation and Management

In the Tracer component, automatic traces are visually distinguished from manually created ones. This distinction is important because:

• Automatic traces should generally not be deleted as they reflect actual usage in the system
• Deleting automatic traces can disrupt functionality that depends on these relationships
• If deletion is necessary, the system will warn you about potential impacts

Domain-Specific Traces

While the general Tracer allows connections between any objects, CertHub also provides domain-specific tracing for specialized use cases. Domain-specific traces create controlled, focused relationships within a specific context.

These specialized traces are developed by CertHub and come as part of specific schema libraries, such as Risk Management or Design Control. Each schema library provides pre-configured relationship patterns that enforce regulatory requirements and best practices for that domain. To learn more about available schema libraries and their specific tracing patterns, see Use Case Explanations.

Understanding Domain-Specific Traces

Domain-specific traces differ from general traces in several ways:

Feature	General Tracer	Domain-Specific Traces
Scope	Any object to any object	Pre-defined relationships within a domain
Context	System-wide	Specific to use cases (e.g., Risk Management, Design Control)
Relationship Types	Generic relationships	Domain-specific meaningful connections
Filtering	Manual selection	Automatically filtered to relevant objects

Example: Risk Management Domain

In a risk management context, domain-specific traces might:

Here, the traces are automatically filtered to show only:

• Harm records associated with the specific product
• Control measures linked to those harms
• Verification records for those controls

Benefits of Domain-Specific Traces

1. Regulatory Compliance

   • Enforces required relationship patterns
   • Ensures complete documentation chains
   • Supports audit readiness

2. Focused Workflows

   • Shows only relevant connection options
   • Reduces errors in relationship creation
   • Streamlines documentation processes

3. Quality Assurance

   • Maintains consistent documentation structure
   • Ensures required links are established
   • Supports validation of documentation completeness

Using Domain-Specific Traces

When working within a specific use case (like Risk Management or Requirements Management):

• Look for the Domain-Specific Tracing section in record drawers
• Follow the suggested relationship patterns
• Ensure all required connections are established

Example: Design Control Traceability

Here's how traceability works in a design control context:

This graph shows:

• Each object's entity type and version
• Directed relationships between objects
• A complete traceability chain from user needs to validation
• How different object types interact in a real process

Global Element Traces

A special form of trace in CertHub is the connection between Global Element records and every other entity in the system. For this purpose, there is a specialized Global Element Tracer component, which is integrated into each object. This allows you to easily establish and manage references from any domain object to Global Elements, ensuring standardized information and traceability across your platform.

For more details, see the Global Elements References page.

Video Tutorial

Watch this tutorial to learn how to effectively use traceability in CertHub: