The FDC platform consists of the LABVANTAGE MICRO/EM client software, a rugged tablet PC, barcode scanner, barcode printer, badge reader and stainless steel cart that can be used to store and transport sampling media and equipment (such as airborne particle counters). The entire configuration (PC, peripherals and cart) can be sanitized using standard chemical disinfectants without harming the devices. The rugged PC operates without a fan and the thermal printer produces no dust to conform to clean room standards.

LABVANTAGE MICRO/EM is an integrated software and hardware solution that improves the performance of Environmental Monitoring (EM) and Quality Control (QC) operations by eliminating inefficiencies and reducing the error rates inherent in manual, paper-based systems.

LABVANTAGE® MICRO/EM™

By removing low value and redundant activities from EM and QC processes, the system delivers a tangible return on investment while serving as a regulatory compliant platform for managing and reporting on the full spectrum of EM and QC information including tests of surfaces, air, personnel, water, compressed gas, as well as product bioburden.

Using wireless technology, LABVANTAGE MICRO/EM provides a mobile computing platform for the paperless collection, processing and tracking of EM and QC samples. An automated workflow engine drives the location-based sampling regimens – improving productivity and ensuring compliance with standard operating procedures. The system includes proprietary “offline” functionality that allows sampling technicians to continue working despite any potential disruption in wireless network connectivity. Once connectivity is restored,

all cached information is automatically synchronized with the server, a 21 CFR Part 11 compliant data repository that serves as the complete system of record for all environmental monitoring and quality control information.

LABVANTAGE MICRO/EM also includes a comprehensive suite of functions to manage the entire EM/QC sample lifecycle, provide automatic action and alert notifications, track progress, report, trend and visualize EM and QC information for both operational and regulatory purposes. To further streamline operations, the system can be easily integrated with standard monitoring equipment such as particle counters for direct data acquisition.

The Field Data Capture (FDC) Platform is a mobile computing platform for collecting, labeling (via barcode) and tracking environmental monitoring samples.

LABVANTAGE® MICRO/EM™

Paperless Microbiology Environmental Monitoring

Headquarter 265 Davidson Avenue, Suite 220 Somerset, NJ 08873 www.labvantage.com

International Sales For our office locations please call the division headquarters or refer to our Web site at http://www.labvantage.com/contact

Figure 1. Map your EM data to the floor plan of your facility to allow quick visualization hotspots

Figure 2. Convenient mobile station for collecting, labeling and tracking samples

Contact UsFor more information and to get a demonstration of LABVANTAGE MICRO/EM contact your local LABVANTAGE sales representative at www.labvantage.com/contact or visit www.labvantage.com

LABVANTAGE is a registered trademark of LABVANTAGE Solutions or its subsidiaries in the US and/or certain other countries.

©2011 LABVANTAGE Solutions. All rights reserved. Information subject to change without notice.

Printed in the USA, 01/2011 Publication 1101JY24CYL

LABVANTAGE MICRO/EM is a fully integrated QA/QC data management platform that improves information quality and operational performance

Feature Benefits

Complete Workflow Automates sampling, testing, incubation, and results-entry functions for EM and Utilities programs, guiding the user and preventing process deviations.

Mobile & Flexible Utilizes specialized hardware, RFID, and barcoding technology to automate data capture at the sampling site.

Entirely Paperless Eliminates all paper schedules, hand-written notes, reconciliation, and transcription activities.

LABVANTAGE MICRO/EM Information Technology (IT) Benefits

Feature Benefits

Ease of Audit Solution provides a single system of record with complete audit trail for all QA and QC data.

Ease of Administration Single data base server to administer and support for QA and QC organizations.

LABVANTAGE MICRO/EM Business Benefits

Feature Benefits

Cost Reduction Significantly less personnel hours on data entry, paperwork, and other clerical functions.

Productivity Improvements

Collect and process more samples with the same or fewer personnel. Refocus personnel on value-added activities.

Enhanced

Compliance

Reduced errors and process deviations; faster turnaround of information for CAPA activities and product release.

Return on Investment The investment typically returns positive cash flow in 6-18 months.

Enhanced Reporting and Analysis

Capability to report on combined set of QA and QC data for product/batch release. Reporting and analysis tools that existing LABVANTAGE users are familiar with.

LABVANTAGEMicro/EM