Ensuring that laboratory processes are compliant with the regulations of the U.S. Food and Drug Administration (FDA), such as 21 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.
To help ensure that procedures which involve the VICTOR® Nivo™ multimode plate reader are compliant, an add-on to the instrument's software is available. Named the Enhanced Security option, this software provides a variety of tools to help you reach compliance for 21 CFR Part 11. With specific reference to the relevant paragraphs of 21 CFR Part 11, this document describes how the tools within the VICTOR Nivo Enhanced Security software facilitate compliance with this regulation.