PerkinElmer
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White Paper

21 CFR Part 11 Guidance for EnSight Multimode Plate Reader

Introduction

To achieve compliance with the regulations of the Food and Drug Administration (FDA) as defined in the 21 CFR Part 11 and other references like the EU Annex 11, you need a well aligned combination of software tools and implemented administrative procedures. With the Enhanced Security option for the EnSight® multimode plate reader software, PerkinElmer provides a variety of tools to simplify your road towards compliance.

This white paper gives an overview of the features and tools provided by the Enhanced Security option for EnSight's Kaleido software with reference to the relevant paragraphs of 21 CFR Part 11.