White Paper Examines New “Thin LIMS” IT Implementation Strategy for cGMP Quality Informatics
HOPKINTON, MASS. – October 20, 2008 — The implementation of a compliant Laboratory Information Management System (LIMS) for the QC/QA laboratory environment is often victimized by “scope creep,” with costs rising 2 to 5 times above originals estimates and forcing the continued funding of a seemingly never-ending project. But a new white paper examines an alternative “Thin LIMS” strategy that promisesto cut the technical resources and costs required for deployment in half.
Titled “Thin LIMS, Thick LIMS — New IT Implementation Strategy for cGMP Quality Informatics — How to Complete a QC/QA cGMP Lab IT Architecture with Half the Technical Resources in Half the Time,” the white paper was derived from one-on-one in depth interviews with IT managers involved with traditional LIMS projects in cGMP quality operations. The white paper is available for download at: http://wwwsc.velquest.com/gmpinformatics/.
Over the last few years, the Thin LIMS strategy has been presented by major pharmaceutical, generic and biotech companies at the annual IMACS (International Meeting on Automated Compliance Systems) conference.
In short, the “Thin LIMS” strategy is the implementation of a commercial LIMS in combination with a GMP Lab Execution System. The LIMS functions are narrowly defined and fixed for quick implementation and are usually “supervisory and administrative functions” while the lab execution system is an off-the-shelf platform for lab “method functions” that include all data and metadata compliance documentation and instrument integration. Through this architecture, the cGMP lab operations are totally automated yielding productivity improvements of 25% or more and cycle time reductions in excess of 50%. Moreover, project cost considerations include a 50% reduction of traditional LIMS implementation requirements, and a cutting of project completion times in half.
The new white paper outlines the key definitions, architecture and cost/benefit considerations for a “Thin LIMS” vs. “Thick LIMS” implementation strategy in cGMP quality operations.
The white paper is authored by John P. Helfrich is the Vice President, GMP Automation Programs at VelQuest Corporation. Helfrich has over 30 years experience in the biopharmaceutical industry as a research analytical chemist and divisional management of several high technology companies that service the life sciences industry. He has authored 28 analytical chemistry and bio-characterization publications.
Download a copy of the “Thin LIMS, Thick LIMS — New IT Implementation Strategy for cGMP Quality Informatics — How to Complete a QC/QA cGMP Lab IT Architecture with Half the Technical Resources in Half the Time” white paper at: http://wwwsc.velquest.com/gmpinformatics/.
About VelQuest Corporation
The VelQuest SmartLab GMP Electronic Notebook System is an innovative software platform designed to provide the foundation for compliance-based activities in the life science markets. The core software embraces the FDA’s “cGMPs for the 21st Century: A Risk Based Approach” and “Quality by Design (QbD) initiatives as well as ICH-Q10 (Pharmaceutical Quality Systems), and supports the company’s SmartLab™ Applications for a fully compliant electronic laboratory, SmartShell™ 21 CFR Part 11 remediation software, and SmartBatch™ manufacturing batch record system.
Founded in January 1999, VelQuest provides a growing suite of unique products to help transform regulated industries from labor-intensive, paper-based operations to automated, efficient systems, with greater confidence in their compliance than ever before possible. For additional information on VelQuest visit our website at www.velquest.com.
