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Is there any guidance available defining “sufficient” time on a site to familiarise a Contract QP with the Quality System?

17/07/2021 | 1617

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Reply:

There is no guidance available. The time on site will depend on the complexity of the quality system. An important consideration is the maturity and stability of the system. If the system is mature and stable a shorter time on site may be indicated, provided that the contract specifies that the QP must be made aware of any changes that affect the quality system.

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