VelQuest ® Partners with Autoscribe Ltd and Zumatrix, Inc. to Provide a LIMS Stability Study Module for Pharmaceutical Quality Operations
Hopkinton, MA, Falmouth, MA and Berkshire, U.K., October 4, 2007 — VelQuest Corporation, the developer of the SmartLab GMP Electronic Notebook System, and Autoscribe Ltd., a laboratory information management (LIMS) provider, announce an integration partnership to support a major multi-site pharmaceutical company. The company is implementing the VelQuest SmartLab GMP Electronic Notebook System for QC/QA cGMP laboratory execution, instrument integration and data capture with integration directly to SAP. To comprehensively design protocols and manage stability data, VelQuest and the client’s choice is the Matrix Stability System, developed by Autoscribe, Ltd. and supplied in the USA by Zumatrix, Inc. This close partnership provides a seamless protocol driven integration with the following key capabilities:
•Protocol Management – creates and maintains the details of conditions, pull periods and tests to perform.
•Study Maintenance Management – holds general information about the study, including description, cost center and products.
•Batch Maintenance Management – holds blend, formulation/recipe, packaging and manufacturing details.
•Location Management – contains storage conditions and locations for each container which can be specified by room, rack, shelf, box and more.
•Inventory Management – calculates the total number or amount of samples required for each study, before it is initiated. Retained samples and those required by the protocol are handled separately.
•Reports – several standard stability reports are included and may be used as designed or modified via Crystal Reports.
•Statistical Analysis – efficient data export to statistics software, such as JMP (SAS Institute) along with scripts for evaluation and analysis of shelf-life claims.
•Lab Procedure Execution – Test methods for the stability studies are delivered to analysts by the GMP electronic notebook with data captured directly from analytical instruments and compliantly integrated with the stability system.
“The Matrix Stability System was designed in cooperation with several pharmaceutical companies and our US Distributor, Zumatrix, Inc.”, says John Boother, Managing Director of Autoscribe. “At our joint client’s multi-site quality organization, VelQuest’s SmartLab platform and the Matrix Stability System combine “best-of-breed” method execution, data capture and stability protocol design and data management for cGMP operations”.
“A major goal in many companies is to eliminate the routine, non-value added and error-prone tasks through automation”, said Ken Rapp, President and CEO of VelQuest. “A key issue in the pharmaceutical industry is that a significant amount of people are dedicated to regulatory compliance functions that use costly paper-based processes. The SmartLab software has been deployed in cGMP facilities worldwide. Users have reported their ability to eliminate the paper-based data capture and documentation processes creating annual operational benefits yielding millions of dollars in efficiency gains. The integration of the Matrix Stability Study System with SmartLab provides a comprehensive protocol design, method execution, automated data capture and compliant documentation management capability for this critical process in cGMP quality operations”
European Seminar/Workshop Series (Ireland and U.K. – October 15-19)
The stability module integration will be discussed at VelQuest’s European Seminar/Workshop’s taking place in Ireland and the United Kingdom from October 15 through October 19. The seminar/workshop entitled “Going Paperless in Pharmaceutical Quality Operations with a GMP Electronic Notebook System” is a half day afternoon event. To learn more and register go to http://www.velquest.com/EuroSeminar.aspx.
About VelQuest Corporation
Founded in January, 1999, VelQuest Corporation provides a suite of configurable off-the-shelf software products to help transition regulated industries from labor-intensive, paper-based operations to automated, efficient systems with greater confidence in compliance than ever before possible.
The SmartLab TM solution uses VelQuest’s electronic Process Management & Compliance (ePMC™) Core Operating System that is an innovative “method-centric” software automation platform designed to provide the foundation for compliance-based activities in the life science markets. The software embraces the FDA’s “cGMPs for the 21st Century: A Risk Based Approach” and “Quality by Design” initiatives, and supports the company’s SmartLab TM applications for a fully compliant electronic laboratory, SmartShell™ 21 CFR Part 11 instrument and application remediation software, and SmartBatch TM electronic batch record system. For more information, please visit http://www.velquest.com/webinars.aspx/ .
About Autoscribe, Ltd.
Autoscribe Limited is a world leader in the development and supply of successful LIMS (Laboratory Information Management Systems) and software solutions for the scientific laboratory and business markets. Autoscribe originally pioneered its unique configuration tools for the LIMS market and today Matrix LIMS software is seen as the industry standard for configurable LIMS to which others aspire.
Autoscribe offers a wide portfolio of standard LIMS and off the shelf, scaleable LIMS, fully configurable LIMS products for Stability Study Management, Training Record Management, Resource Planning, Nuclear Industry LIMS for District Surveys, Chemistry and Liquid Discharge, Water / WasteWater Management LIMS, LIMS for the Food Industry, Environmental Monitoring LIMS, Instrument Calibration and Maintenance, Sample Tracking, Customer Complaints and Feedback Management. Autoscribe’s Scientific and Business software solutions are:
•Faster to Implement
•Easier to Use
•Better by Design offering Better Returns on Investment
•Designed for Business Change
In North America, Autoscribe products are supplied and supported by Zumatrix, Inc. of Falmouth, MA. For more information on our entire product line and services go to http://www.autoscribe.co.uk or email us at matrix@autoscribe.co.uk
