LabVantage launches compliant-ready LIMS addressing FDA data integrity guidance
Wednesday, October 11, 2017
LabVantage Solutions, a provider of laboratory informatics solutions and services, announces the release of LabVantage 8.3, the newest version of its powerful LIMS software and first GxP-compliant solution for data integrity and auditing, to help drug manufacturers conform to the FDA draft guidance on “Data Integrity and Compliance with CGMP.”
The new Dynamic Auditing feature of the LabVantage LIMS platform ensures 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 U.S. Food and Drug Administration (FDA), U.K. Medicines and Healthcare Products Regulatory Agency (MHRA), and World Health Organization (WHO) would 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 The FDA draft guidance states that electronic data that will become part of a permanent CGMP record cannot be stored electronically in temporary memory where it could be subject to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 helps 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 (even 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
“LabVantage is the only LIMS provider in the market today to proactively update our software to offer a solution for data integrity and auditing,” said Ram Velidi, President at LabVantage Solutions. “We continue to deliver on our promise to customers to provide state-of-the-art technology that is second to none and is at the leading edge of laboratory information management solutions and the evolving regulatory landscape.”
New Functionality for ELN/LES
LabVantage has also expanded its inventory of Laboratory Execution System (LES) worksheets. In addition to the existing LES worksheets based on Test Methods, new LES worksheets are now available for: QC 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 Electronic Laboratory Notebook (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
- Better Storage Explorer capabilities to search for open/empty spaces for new samples.