LabVantage 8.3 Helps Manufacturers Conform to FDA Data Integrity Draft Guidance

LabVantage 8.3 is the newest version of LabVantage Solutions’ laboratory information management system (LIMS) software and its first good practice (GxP)-compliant solution for data integrity and auditing. The new software, released in October 2017, is designed to help drug manufacturers conform to FDA’s draft guidance, Data Integrity and Compliance with CGMP.

A new dynamic auditing feature in the company’s LIMS platform will help ensure that companies are able to meet current and proposed regulatory guidance for data management in temporary memory. New and emerging data integrity standards put forth by FDA, UK Medicines and Healthcare Products Regulatory Agency, and World Health Organization would require the capture of temporary data in electronic records. FDA’s draft guidance states that electronic data that will become part of a permanent cGMP record cannot be stored electronically in temporary memory where it could be subject to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.

New Functionality for ELN/LES

In addition to the new software, LabVantage has also expanded its inventory of laboratory execution system (LES) worksheets. The company has added new LES worksheets to its existing LES worksheets, which are based on test methods. The new 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, the chemical viewer, has also been added to the electronic laboratory notebook (ELN) and LES. With this viewer, users can upload a chemical file to a designated location or copy it into the control system. It 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.

Source: LabVantage