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Repeatability... The FDA does not view that scientists building a custom unit with their own hands is desirable. What is desirable to the FDA is a system of controls and documents to equip unskilled production workers to be trained to build, test and ship medical devices. The first unit must be made the same as the last unit made (except for production changes.) using specified tools and material.

Repeatability can only be achieved with discipline - usually no more discipline than what is required for any simple laboratory experiment as taught in Chemistry, but it must be planned, executed and recorded with good practice. This discipline requires that a process be detailed in written, controlled standards to the extent that the process will yield the same results regardless of who performs the process. Results from the process (random samples) must be verified based on a predetermined standards. What makes this so difficult is the FDA requires that every pill made this month will be the same as pills made in one year (within tolerances). copyright by Compliance Consultants, Stamford, CT USA, September 2001