mercedes E 200 cdi
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The answer is ??no??. It is not possible for any vendor to offer a turnkey 21 CFR ??Part 11 compliant system.? Any vendor who makes such a claim is incorrect. Part 11 requires that both procedural controls (i.e. notification, training, SOPs, administration), and administrative controls are put in place by the user, in addition to the technical controls that the vendor can offer. At best, the vendor can offer an application containing the technical requirements of a compliant system.[1]
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