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EASA 6.1 eSignature functionality

EASA eSignature provides digital validation of the integrity of a previously certified data set.

EASA eSignature meets the FDA's quality standards, trace-ability and data integrity requirements for the pharmaceutical industry.

  • EASA 6.1 eSignature functionality has two main parts,
    1. ESIGNER and at least one Child STAGE OPTIONS,
      • allow an authorized party to create an electronic signature to validate the integrity of an EASAP's state
      • store the signature in the EASA database
      • compares the integrity of the current EASAP state against the signed state in the EASA database
      • displays a table of valid signatures going forward in time

ESIGNER's 'validation of integrity' process may be repeated through an arbitrary number of stages.

EASAP data at each stage must be signed to move to another stage.

An optional final step allows EASAP data to be locked, see Lock ESIGNER button.

Below is an example showing ESIGNER and ESIGNER VIEWER GUI objects.