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.