Module 14 2022

22/03/2022

GOOD DESIGN PRACTICE

DESIGN CHANGE: IMPROVEMENT AND OPTIMISATION ● Must be properly documented ● Supported by a change management process, including: – Request form – Engineering change order

● ALL CHANGES reflected in the DESIGN HISTORY FILE

Masterclass: Lecture 1

The Organisation for Professionals in Regulatory Affairs

47

DESIGN CONTROLS

WHAT ARE THEY?

● A set of documented methods for ensuring that: – what you think you are developing is what you wanted to develop in the first place and – what finally comes off the production line is what the customer needs and wants, and – you can legally market and distribute it.

Masterclass: Lecture 1

The Organisation for Professionals in Regulatory Affairs

48

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