A key part of US and International compliance is to demonstrate tracing between Design Inputs and Design Outputs .

  • Each User Need must be completely addressed by one or more Requirements.
  • Each User Need must be confirmed by one or more Validations. 
  • Each Requirement must be completely satisfied by one or more Design Output. 
  • Each Requirement must be confirmed by one or more Verification. 

Furthermore

  • Each Requirement must address, at least partially one or more User Needs.
  • Each Design Output must satisfy, at least partially, one of more Requirement.
  • Each Verification must confirm, at least partially, one or more Requirement.
  • Each Validation must confirm, at least partially, one or more User Need.

Once you have added the new card (including its dependencies) clicking on the circle icon will show you all the design cards linked to it. It is important to indicated any design dependencies before you submit for approval. 

Tracing
The Tracing toggle (accessed under the View options menu) shows tracing between the design control cards. 

When this toggle is enabled, and you hover over any card, you can see its connection to others. Incomplete traced items will have the red link.  Once design control cards are approved (i.e not in draft state) and the tracing dependencies between the cards is complete, the items have the green link. 

If you have any questions, you can reach us through the chat or email us at support@enzyme.com.

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