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 GxP and FedRAMP

FedRAMP is mandatory for government cloud deployments. Businesses must comply in order to offer services to federal government agencies.  Life Sciences Companies must comply with 21 CFR Part 11 requirements.

ByteGrid's VP of Governance, Risk and Compliance, Stephen Ferrell, was asked by the FDA's cross divisional Cloud Working Group to trace 21 CFR Part 11 to FedRAMP.   The presentation takes a look at 38 select controls against the following criteria:

  • Data Integrity and security
  • Service level agreements
  • Compliance to Part 11, GxP's
  • Validation for intended use