Design Controls are an integrated set of management practices (policies, processes and procedures) which are applied to control design activities while assessing quality and correcting errors through an iterative process of development. As a result, the end user benefits from a safe and effective product and the manufacturer benefits from a successful return on investment, According to Federal Regulations 21 CFR 820.30 you need to have a complete Design Control System:-
1) Design Control
2) Design and Development Plan
3) Design Input
4) Design Output
5) Design Review
6) Design Verification
7) Design Validation
8) Design Transfer
9) Design Changes
10) Design History File (DHF)
11) Risk and Hazard Analysis activities