Using Good Engineering Practice und Best Practice Sharing to reduce cost

Recent validation principles like scalable life cycle activities and a science-based quality risk management form a challenge that has to be mastered.

Because of his subject matter expertise the supplier may have considerably involved in the process. The provided information may be used:

  • while preparing specifications to define how regulatory requirements will be met

  • to identify the complexity and novelty of the applied components and techniques

  • during the determination on the required life cycle activities

  • during risk assessment

  • for defining the test strategy

The best practice documents:

  • explain specific requirements in the context of the selected product

  • serves as a guideline for selecting components

  • supports subject matter experts during the determination on the most appropriate planning and validation strategies as well as for defining acceptance criteria

  • include lots of consideration for the configuration of specific functions