What Requires an Electronic Signature?

Any process or experiment that requires review by multiple individuals should have an electronic signature. Electronic signatures can be added as part of a 21 CFR Part 11 compliant workflow or as a way for an organization to record how/why a process or experiment was approved.

The reasons and workflows for an electronic signature can vary by organization, but typically fall into the following scenarios:

  • Using signatures to record who approved a process design or experimental data.
  • Using signatures to formalize the signing process that occurs with a typical lab notebook
  • Using signatures to request supervisor approval on completed work

These scenarios are typically augmented by organizational SOPs that govern how/why/when signatures are applied. Details on a mock use case can be found here.

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