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Article

Achieving 21 CFR Part 11 Compliance with TotalChrom Client/Server Software

Introduction

Title 21 of the Code of Federal Regulations (CFR) is the section of the United States government Rules and Regulations document that deals with the Food and Drug Administration (FDA). Chapter 1, Part 11 of this Section applies to records in electronic form and to the criteria under which the FDA will consider electronic records and signatures "to be trustworthy, reliable, and generally equivalent to paper records and handwritten signatures on paper".

The purpose of this document is to describe the relevant portions of the 21 CFR Part 11 regulations, and to explain their implementation using PerkinElmer's TotalChrom Client/Server software.