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.

“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”

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.

Matrix LIMS and Stability Study Management software is :

• Faster to Implement
• Easier to Use
• Better by Design offering Better Returns on Investment
• Designed for Business Change

VelQuest is a registered trademark of VelQuest Corporation. ePMC, SmartLab, SmartShell and SmartBatch are trademarks of 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 SmartLabTM 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 SmartLabTM applications for a fully compliant electronic laboratory, SmartShell™ 21 CFR Part 11 instrument and application remediation software, and SmartBatchTM electronic batch record system.

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