How do you make a decision on "good enough" and how do you align with the regulators on this decision?

“Good enough” is difficult to define, but it needs to be tied to risk. The best way to start is to look at safety and compliance risk using existing guidance. Also, doing a gap assessment of the documentation, ranking the gaps by risk level, and aligning with your risk management process will help you get toward developing a remediation plan and strategy and communication with regulators.

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