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:6/27/2016)... June 27, 2016  Sequenom, Inc. (NASDAQ: ... healthier lives through the development of innovative products and ... the United States denied its petition ... claims of Sequenom,s U.S. Patent No. 6,258,540 (",540 Patent") ... established by the Supreme Court,s Mayo Collaborative Services v. ...
(Date:6/27/2016)... June 27, 2016  Liquid Biotech ... funding of a Sponsored Research Agreement with The ... cells (CTCs) from cancer patients.  The funding will ... levels correlate with clinical outcomes in cancer patients ... will then be employed to support the design ...
(Date:6/24/2016)... ... June 24, 2016 , ... Researchers at the Universita Politecnica delle Marche in ... peritoneal or pleural mesothelioma. Their findings are the subject of a new article on ... biomarkers are signposts in the blood, lung fluid or tissue of mesothelioma patients that ...
(Date:6/23/2016)... 23, 2016 A person commits a crime, and ... to track the criminal down. An outbreak of ... Drug Administration (FDA) uses DNA evidence to track down the ... Sound far-fetched? It,s not. The FDA has increasingly used a ... of foodborne illnesses. Put as simply as possible, whole genome ...
Breaking Biology Technology:
(Date:4/26/2016)... , April 27, 2016 ... "Global Multi-modal Biometrics Market 2016-2020"  report to their ... , The analysts forecast the global ... of 15.49% during the period 2016-2020.  ... of sectors such as the healthcare, BFSI, transportation, ...
(Date:4/13/2016)... April 13, 2016  IMPOWER physicians supporting Medicaid patients ... a new clinical standard in telehealth thanks to a ... the higi platform, IMPOWER patients can routinely track key ... body mass index, and, when they opt in, share ... visit to a local retail location at no cost. ...
(Date:3/22/2016)... , March 22, 2016 ... report "Electronic Sensors Market for Consumer Industry by Type ... Others), Application (Communication & IT, Entertainment, Home ... Global Forecast to 2022", published by MarketsandMarkets, ... expected to reach USD 26.76 Billion by ...
Breaking Biology News(10 mins):