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Guidance for Ensuring Your EnVision Multimode Plate Reader Complies with 21 CFR Part 11

Introduction

Ensuring that laboratory processes are compliant with the regulations of the U.S. Food and Drug Administration (FDA), such as CFR Part 11, and other references (e.g. Annex 11 published by the European Commission) can be time-consuming and laborious, requiring meticulous documentation of procedures and record-keeping.

Our compliance software, Enhanced Security, for EnVision® provides a variety of technological controls and features to help you navigate the road towards compliance with 21 CFR part 11 easier and faster.

Download this document and learn how the tools within the EnVision Enhanced Security software support 21 CFR Part 11 compliance with access levels, data security, and a comprehensive audit trail of user actions.