LabVantage Solutions, a Somerset, New Jersey-based laboratory informatics provider, has released LabVantage 8.3, the newest version of its laboratory information management system (LIMS) software and a GxP-compliant service for data integrity and auditing to help drug manufacturers conform to the US Food and Drug Administration (FDA) draft guidance, Data Integrity and Compliance with CGMP.

The company says the new Dynamic Auditing feature of the LabVantage LIMS platform helps ensure that companies are able to meet current and proposed regulatory guidance regarding the management of data in temporary memory. New and emerging data integrity standards put forth by the FDA, the UK Medicines and Healthcare products Regulatory Agency, and World Health Organization require the capture of temporary data in electronic records. The FDA draft guidance states that electronic data that will become part of a permanent cGMP record cannot be stored electronically in temporary memory where it could be subject to manipulation.

LabVantage’s Dynamic Auditing tool is designed to help users maintain a clean and complete, GxP-compliant audit trail based on a full history of analytical testing, including: temporary and permanent data; changes between temporary and permanent data entries (including before a page is saved) and the reason for the change; identity of person entering the data; date and time of data entry; electronic signatures and mandatory reason for changes; and new functionality for Electronic Laboratory Notebook (ELN)/ Laboratory Execution System (LES).

LabVantage has also expanded its inventory of LES worksheets. In addition to the existing LES worksheets based on test methods, new LES worksheets are now available for: quality-control batch testing used during the testing of unknown samples; instrument certification used to maintain and calibrate instruments; and finished product sample testing, which facilitates the review of multiple analytical tests on a single sample.

Another new tool is LabVantage’s Chemical Viewer, which has been added to the ELN and LES. With the Chemical Viewer, users can upload a chemical file to a designated location or copy it into the control system. The viewer offers an editable graphic rendering of the chemical structure defined in the file.

Other new features of LabVantage 8.3 include: improved reagent integration within the advanced batch control module; additional enhancements to array- and plate-handling, specifically with persistent auditing on reasons, activity, and electronic signatures; and better storage explorer capabilities to search for open/empty spaces for new samples.

Source: LabVantage