Looking to improve your compliance profile? This is an obvious point, but sometimes the most obvious points are the ones that are most overlooked. Make sure that you understand and refer to the details of the relevant section of the regulations. Most regulations are there because they make sense.

For example, with respect to CAPA management, the FDA QSRs spell out the expectations, and when you think about it, they are very logical with respect to providing a route to achieving the intended outcome (effective corrective or preventive action).

Use the regulation to derive your own, detailed procedure, and then be able to show that you adhere to this procedure in practice.

There should be demonstrable linkages from the requirements of the Regulations to your Organization’s Procedure to the actual day to day practices in place. Not only will this improve your compliance profile- it will help you to be effective.