Mistake proofing and redundancy in machine validation.
Mistake proofing and redundancy in design are becoming essential features of the validated environment. Properly applied and embraced, they will further increase the reliability of machines and the quality of the products emerging from the medical device industry. More importantly they will help focus validation on machine enhancement and reliability and reduce the dependence on operator intervention and vigilance in ensuring desired quality levels are achieved. They are the only way of eliminating the transient fault and aberration in performance that has arisen from the complexity of modern machine design.
Blake
Noel
N
Doyen Medipharm Ltd, Barton, UK. noel@doyenmedipharm.co.uk
D017076:Computer-Aided Design; D004867:Equipment Design; D004868:Equipment Failure; D019544:Equipment Failure Analysis / Q000379:methods*; D004869:Equipment Safety / Q000379:methods*; D004864:Equipment and Supplies; D011786:Quality Control; D018570:Risk Assessment / Q000379:methods*; D012986:Software Validation