Design History File
The Design History File (DHF) is a collection of documents associated with a product's design.
It generally includes:
Design Control items (Design Inputs, Outputs, Verifications, validations)
Design Reviews
Protocols
Reports
Architecture documents
Risk Management file
In Enzyme, there are three ways to access a product's design history.
Design History for a Design Control category of a product
Design History documents associated with a product
Trace matrix for a product
Risk Management Module
The Risk Management Module, allows you to determine the risks for a product and how you can mitigate those risks.
Managing Risk
In the Risk Management module, you can add hazards, the situations, and harms associated with it.
Managing Hazards
Managing Situations