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In Medical Device Manufacturing and in Pharmaceutical Production, Strict Traceability

Question 64

Multiple Choice

In medical device manufacturing and in pharmaceutical production, strict traceability is mandated by regulation. What type of actions may draw upon this requirement?


A) Fulfillment of an unconditional guarantee II. Replacement of failed product under warranty III. A product recall that is needed to safeguard product users IV. Analysis of problems leads to process improvement
B) II, III, and IV only
C) III and IV only
D) I, II, and III only
E) I, II, III, and IV

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