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Validating Computer Systems

Brief Description

Our seasoned validation consultants support in the process of ensuring that any technology component (software or hardware) is fulfilling its purpose in line with the regulatory guidelines within GxP environments.  More specifically, FDA CFR Part 11 regulations require implementing controls, including audits, system validations, audit trails, electronic signatures, and documentation for software and systems involved in processing electronic data.This is an area many of our clients struggle with, our seasoned validation professionals can assist with these assessments and audits of such systems.