Navigation Links
White Paper Examines New 'Thin LIMS' IT Implementation Strategy for cGMP Quality Informatics
Date:10/20/2008

HOPKINTON, Mass., Oct. 20 /PRNewswire/ -- 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 promises to 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, 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(TM) Applications for a fully compliant electronic laboratory, SmartShell(TM) 21 CFR Part 11 remediation software, and SmartBatch(TM) 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 http://www.velquest.com.


'/>"/>
SOURCE VelQuest
Copyright©2008 PR Newswire.
All rights reserved

Related biology technology :

1. Free White Paper Now Available: How to get the most from your visit to electronica 2008 in Munich
2. White Paper Explains Aspects of Testing From Purified Bulk Drug Substance to Sterile Liquid Final Drug Product
3. Lillys Connelly Appointed to the Presidents Commission on White House Fellowships
4. White Paper Helps Hospitals Prepare Staff for Joint Commission Environment of Care Interview Sessions
5. White Paper Details New Techniques for Isolating, Identifying Anaerobic Bacteria and Organisms
6. White Paper Advises Pharma Manufacturers on How to Select an Aseptic Fill/Finish Contractor, Avoid the Most Common Mistakes
7. White Paper Details Environmental Health & Safety Compliance Strategies for Laboratories
8. Marteks lifesDHA(TM) Now Featured in Two New Flavors of Rachels(R) Wickedly Delicious Yogurt from WhiteWave Foods
9. Insmed CEO Issues Statement on White House FY09 Budget and FDA Statements on Follow-On Biologics
10. White Paper Details Infection Control Challenges Hospitals Must Address During Construction
11. Free White Paper Available for Clinical Laboratory Managers: Effectively Isolating Anaerobic Bacteria
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:5/3/2016)... ... May 03, 2016 , ... Wearable Tech + Digital ... will take place on June 7-8, 2016, at the New York Academy of Sciences.  ... technology -- including AR/VR, machine learning, apps, robotics and AI -- throughout a major ...
(Date:5/2/2016)... 2016 Q BioMed Inc. (QBIO), ... Mannin Research Inc. will be attending the Association for ... from May 1-5, 2016 in Seattle Washington ... its vendors and research partners. The meeting provides organizations ... other collaborative opportunities for the MAN-01 program for treatment ...
(Date:4/29/2016)... ... April 29, 2016 , ... Proove Biosciences, ... to announce the launch of the Proove Health Foundation . The Foundation ... to promote the use of personalized medicine for tackling the nation’s most-pressing healthcare ...
(Date:4/29/2016)... ... April 29, 2016 , ... Intelligent Implant Systems announced ... FDA via 510(k) for sale in the United States. These components expand the ... fusions. With one-level sales beginning in October of 2015, the company has seen ...
Breaking Biology Technology:
(Date:3/31/2016)... , March 31, 2016  Genomics firm Nabsys ... founding CEO, Barrett Bready , M.D., who returned ... of the original technical leadership team, including Chief Technology ... of Product Development, Steve Nurnberg and Vice President of ... to the company. Dr. Bready served as ...
(Date:3/23/2016)... , March 23, 2016 ... erhöhter Sicherheit Gesichts- und Stimmerkennung mit Passwörtern ... (NASDAQ: MESG ), ein führender ... das Unternehmen mit SpeechPro zusammenarbeitet, um erstmals ... Finanzdienstleistungsbranche, wird die Möglichkeit angeboten, im Rahmen ...
(Date:3/22/2016)... and SANDY, Utah , March ... operates the highest sample volume laboratory in ... and UNIConnect, leaders in clinical sequencing informatics and molecular ... of a project to establish the informatics infrastructure for ... NSO has been contracted by the Ontario Ministry ...
Breaking Biology News(10 mins):