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

Managing Harms

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