With FDA support we mean the possibility of enabling the support of the FDA CFR21 Part 11 regulation in the product.
The purpose of this regulation drawn up by the FDA (Food & Drug Administration) is to obtain the legal equivalence of electronic documents (digital records and electronic signature) compared to traditional paper ones.
In order for the automation system created to comply with the regulations, it is necessary to ensure that the recorded data can always be traced back to the responsible operator (through an electronic signature mechanism) and precautions are necessary that make it impossible to falsify or tamper with the electronically recorded data.
The main purpose of the legislation is therefore to record all the operations carried out by the operator, uniquely identify the operator and ensure that the data cannot be tampered with.
Here below the main steps to be followed:
User definition
Identify the events that has to be recorded
Log export to a secure document
FDA functionality enable
in order to enable the FDA support it is necessary to select the option below.
