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Capa

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  • A lot of things have to come together…each of these steps are important and need skills, subsystems, etc. – some thoughts on most challenging…..Investigations ( to root cause ) and good verification and validation- People need the skills..but most importantly they need good judgment Finally – it is only as good as the records reflect . . .
  • One perspective is …. Industry struggled with adapting to the new QS as a system … came at it in parts…some with parallel implementation…more recently getting better at connecting the dots in the system…in the next slides…talk about some possible reasons
  • Is it easier for a smaller firm? …they face limited expert resources…people wear many hats… Larger firms … the complexity is multiplied by the number of products, locations, divisions, etc.

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