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24th Mar 2020, 04:49 PM
#1
Electronic signatures - validated systems needed?
Three questions:
1. please can you direct me to a guidance/regulation/recommendation that states that an electronic signature used in the GXP environment requires to be issued using a validated computer system?
2. If I can not find any "rules", thus would it be acceptable to use a non-validated computer system to sign any GXP documents with an electronic signature (e.g. using a non-validated DocuSign process) ?
3. Even if Q2 is answered with "NO" and rational is given using output of Q1, would it be acceptable to sign vendor contracts using a non-validated system for electronic signatures as the Legal Departments are considered outside the remit of GXP requirements, thus they could use non-validated systems for their electronic signatures?
Any thoughts are much appreciated. Thank you
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25th Mar 2020, 10:11 AM
#2
Might be a good idea to look at the other threads below this one
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21st Oct 2024, 03:01 PM
#3
The topic is quite old and no one has yet given clear answers. To my knowledge, the guidelines for electronic signatures in GxP: FDA 21 CFR Part 11 outlines the requirements for electronic signatures in a GxP environment. This regulation specifies that electronic signatures must be unique to an individual and must be issued using a verified system. In addition, the EMA (European Medicines Agency) provides guidance that emphasizes the need to validate the systems used to create and manage electronic records and signatures. But the use of an unverified system is usually unacceptable, since the integrity, authenticity and irrefutability of records must be ensured, which can only be guaranteed with the help of verified systems.
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