ABSTRACT
Change control is required for validated systems. In the Food and Drug Administration’s (FDA’s) guidance on “Computerized Systems Used in Clinical Investigations,” Section IV.F.5, we learn: “The effects of any changes to the system should be evaluated and some should be validated depending on risk. Changes that exceed previously established operational limits or design speci—cations should be validated. Finally, all changes to the system should be documented” (author’s emphasis). This statement nicely summarizes what is required. This chapter will discuss the requirements for controlling changes in a bit more detail by looking at what falls under change control and exactly what issues should be covered in evaluating the impact of each change.
