ResourceLab Informatics
Understanding the Regulations and How LabVantage Successfully Helps Customers Comply With These Requirements
30 Aug 2018This paper outlines the requirements of 21 CFR Part 11 and Annex 11, and provides information on how LabVantage software supports customers in complying with the regulations. The LabVantage software includes its laboratory information management system (LIMS), electronic laboratory notebook (ELN), and laboratory execution system (LES).
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LIMSLIMS (Laboratory Information Management System) is an informatics software system used to improve the quality assurance and quality control (QA / QC) of data management. LIMS can be a standard for common lab workflows, such as commercial off the shelf systems (COTS), or customized for more specialized lab use. Systems are available for mainframe computers or PC.Electronic Laboratory NotebooksElectronic Laboratory Notebooks (ELNs) are becoming increasingly popular for documenting experimental processes and for lab data management. An ELN is informatics software which can be biology specific, chemistry specific, cross-disciplinary or web-based. Advantages of an electronic lab notebook include increased data protection, efficiency and straightforward data searching and sharing.Software PlatformsSoftware platforms are useful for various stages of laboratory experiments from data collection to data storage and processing. For instance lab software is available for system control, data management, data analysis and qualification / validation.FDAThe Food and Drug Association (FDA) is an agency within the U.S. Department of Health and Human Services. Among other things, it is responsible for ensuring the safety, effectiveness and quality of drugs, vaccines and other biological products, and medical devices. Regulatory
