LabVantage Launches Compliant-Ready LIMS Addressing FDA Draft Guidance on Data Integrity

LabVantage Solutions Inc., a leading provider of laboratory informatics solutions and services, has announced 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and first GxP-compliant solution for data integrity and auditing, to help drug manufacturers conform to the FDA draft guidance on “Data Integrity and Compliance with CGMP.”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 The FDA draft guidance states that electronic data that will become part of a permanent CGMP record cannot be stored electronically in temporary memory where it could be subject to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.

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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.”

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