In 21 CFR 820.100 in the code of regulations, it has a checklist in the back of the book as auditing questions for the various processes. A few of the questions are "Is there a documented and properly implemented procedure for the collection and processing of design-related defects? Does the procedure explain the decision process to pursue the investigation and corrective action of the root cause? Also, " Are appropriate statistical techniques applied to analyze design-related defect data to identify opportunities for corrective or preventative action and to detect recurring problems? 21 CFR 820. 100 (a). With all of this being said, does an organization have to include design defects in their CAPA system or can it be completed through change control? Also, does the CAPA system have to align with the design control process according to the 21 CFR 820.100 clause?