ResourceLab Informatics
Analyst® LC/MS Software and 21 CFR Part 11 Regulations
22 Jun 2017The purpose of this paper is to present an approach to assist the user in meeting 21 CFR Part 11 compliance with Analyst® LC/MS Software version 1.2 and above, including Analyst Software 1.4.1, when used in quantitative studies supporting Good Laboratory Practice (GLP) bioanalytical studies. In this paper, the joint responsibilities between a supplier and its customers to support users’ 21 CFR Part 11 compliance is outlined.
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Data AnalysisData analysis hardware and software is available to make data processing straight-forward yet powerful. Data software can be used for math and stats, technical graphing and image analysis. In addition, software is available for specific data analysis of electrophoresis, densitometry, ELISA and DNA sequencing.RegulatoryPharmaceutical regulations impact on all areas of drug development, manufacture and control and supply. Services are provided from the early stages of drug development and clinical trials through to dossier submission, approval and marketing. Regulatory also includes submission of analytical studies from the pharmaceutical product and safety. Software SolutionData AnalysisThe analysis of data is the process of transforming, modeling and evaluating data to discover useful information from experimental results. Data Management