Somerset, NJ. December 12, 2012. LABVANTAGE announces the release of the new LABVANTAGE Pharma package. LABVANTAGE Pharma is the world’s only pre-validated, preconfigured pharmaceutical LIMS. It allows laboratories to get up and running fast with a fully operational and validated LIMS at a fraction of the cost and time of a traditional LIMS project.
Jeff Vannest, Director of Strategic Solutions, states that “LABVANTAGE Pharma is unique in the industry: it is a pre-validated, preconfigured LIMS package for pharmaceutical environments. This includes a copy of the LABVANTAGE 6 software that has been preconfigured for pharmaceutical use; a comprehensive, GAMP-based validation document suite; document templates for all phases of the project implementation life cycle; on-site process analysis and master data mapping to the LV software; project management and services to complete the implementation; training and more.”
LABVANTAGE Pharma’s pre-validation feature offers great benefits to customers as it has the potential to save a tremendous amount of time. “After the package is assembled, we execute the entire validation suite and provide complete evidence of everything that was done to validate our own controlled system”, explains Vannest. This can cut time tremendously as the process of validation can be very meticulous and time-consuming. We also “include the CVs and training records of everyone involved and scanned copies of every signed document from User Requirements, Risk Assessment, Validation Master Plan, Test Strategy, IQ, OQ, PQ, Validation Summary to System Release Memo,” continues Vannest. This evidence allows customers to accelerate their system implementations as GAMP guidance specifies that if a supplier can show documented evidence of testing, then the testing does not need to be re-executed.
The software arrives preconfigured, with typical laboratory user roles and customer-specific business process workflows. The pharmaceutical-specific functionality includes lot and batch management, stability testing, full sample life cycle management, dashboards, label printing and more.
Other features of the package include configuration assistance for up to five product definitions, including test methods, specifications, and stability protocols. Role-specific training for administrator and key personnel are also included to ensure all users understand and become productive on the new LABVANTAGE Pharma system.