logoförCAEasy Signature is a electronic signature solution (e-signature) that allows digital signing of any type of file.

It enables the replacement of time-consuming and costly paper-based approval processes with fast and secure electronic signature. It is decentralized, that means it gives you control and does not require costly IT-infrastructure.
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Regulatory Compliance

What is important to know in general about digital signature solutions is the following:

"It is not possible for any vendor to offer a turnkey 'FDA 21 CFR Part 11 compliant system'. Any vendor who makes such a claim is incorrect. Part 11 requires both procedural controls (i.e. notification, training, SOPs, administration) and administrative controls to be put in place by the user in addition to the technical controls that the vendor can offer. At best, the vendor can offer an application containing the required technical elements of a compliant system." (check this with FDA or other ISO regulatory)

Easy signature does have the required technical elements of a compliant system. Using out onsite validation support package you get access to document templates  and regulatory support to get compliant.

Example of needed documents:

  • User requirement specification
  • System specification
  • Validation Plan & documentation plan
  • Installation Qualification (IQ)
  • Operational/ Performance Qualification (OQ/PQ)
  • Custom User Manuals (SOP)