Here is an overview of the features and functionality of the Design Control module in Enzyme.
Best Practices - User Needs
Writing descriptive design items can ensure that your product is designed and used as intended. It helps establish and maintain the design and development activities across the various groups working on the product.
The process begins with documenting the user needs of the product.
Best Practices- Requirements
Requirements are derived primarily from user needs as the user is the key stakeholder for the system.
Imagine you’re handing off your requirements to a design firm, they should be able to implement a design that meets your user needs, without significant intervention or rework.
Best Practices - Design Outputs
Design outputs are the work products or deliverables of a design stage.
Examples include diagrams, drawings, specifications, and procedures. The outputs from one stage may become inputs to the next stage. The total finished design output consists of the device, its packaging and labeling, and the device master record.
Best Practices - Verifications
Design Verifications confirm that the design outputs meet the engineering specifications. This usually involves testing to confirm performance and functionality, and help identify any errors and failures that could impact the product.
Best Practices - Validations
Validations determine whether the product meets the user's needs and intended use. These are typically documented in one or multiple protocols and reports and become part of the Design History File.