Scope of DocuSign and Contracts

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      Katie Kelly

      Hello all,
      We are implementing DocuSign with our contracts management system, and will have both the standard (non-compliant) and Business Pro (Part 11 complaint) versions. Currently we’re thinking about requiring only clinical contracts to be signed by the Part 11 compliant version of DocuSign.

      What should the scope of part 11 compliant contract signatures be? Should all contracts be signed with the validated version of DocuSign? For example, all clinical and non-clinical contracts, all GMP contracts, general consulting agreements, agreements with legal firms or for finance audits.


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