WWiinnLLIIMMSS™™Laboratory Information Management System

Quality Systems International GmbH

WWiinnLLIIMMSS™™--AAuuttoommoottiivvee ffrroomm QQSSII

Quality Systems International Quality Systems International’s Laboratory Information Management System WinLIMS.NET™ is the industry's most feature-rich LIMS that is ready-to-use right Out of the Box. What differentiates QSI from other LIMS vendors is our customer's satisfaction level with both our products and services. The evidence of this is clear from Forrester Research Group's 2005 LIMS Watch Report which notes that: • QSI is the ONE LIMS vendor that can implement a

system in only one to three months (Out-of-the-box) • More than 80% of WinLIMS™ customers go live in

the first six months • QSI is #1 in customer satisfaction (93 % of

WinLIMS™ customers!) A more recent survey, the 2007 LIMS Market Watch Report sees QSI at the first place in all categories and summarizes: Again, QSI users were the most satisfied with the LIMS implementation experience. Specifically we are first in • Exceeding customer expectations • Understanding the project goals of our customers • Continuity between sales and implementation • Ease of maintenance of the productive system WinLIMS™ Through extensive experience with over 800 labs using WinLIMS™ throughout the world, QSI has developed extensive LIMS (Laboratory Information Management System) functionality for a variety of different industry sectors. WinLIMS™ is a sophisticated laboratory software package that can manage all of your sample workflow and business logic. WinLIMS™ combines manual interaction with automated data integration with analytical instruments, ERP (e.g. SAP, JDE, Prism etc.), process control, customer relations and project managment systems to provide smooth and efficient flow

of information within your organization. Comprehensive reporting of data is provided using Crystal Reports™ / Business Objects™ and the Microsoft Office™ suite. Other reporting tools that work with our supported databases (SQL Server™ and Oracle™) can be used immediately.

WinLIMS™-Automotive WinLIMS™ contains a comprehensive set of functionality in base system that can be extended by various optional modules. In this way all industry-specific requests can be covered without compromise. WinLIMS™-Automotive is a package that was designed to meet the specific needs of the automotive industry. WinLIMS™-Automotive provides a comprehensive set of functionality for laboratories in the automotive industry to optimally cover the typical workflows and boost quality, safety and productivity. WinLIMS™-Automotive will typically be used enterprise-wide, in many countries in many languages. Apart from automatically using local culture (language, decimal point…) dependent on the

WWiinnLLIIMMSS™™--AAuuttoommoottiivvee ffrroomm QQSSII

user WinLIMS™-Automotive can provide a single, encompassing system for different departments having different requirements (form layout, functionality, tests). WinLIMS™-Automotive has a high level of embedding the sample submitters/customers into the workflow of the system. This is of vital importance for the high level of acceptance in this area: customers can e.g. submit their laboratory work requests via a WinLIMS™ web module and get it plausibility checked immediately.

Fig. 1: Web module for requests No more delays because of incomplete/inaccurate sample information of test requests. At any moment in time customers can query information about the status of their lab work orders, incl. partial results. Certificates of analysis are available via the internet or can be sent by email automatically. Due to the nature of the requirements a combination of WinLIMS™ web-client (mostly external, submitters) and forms-client (mostly internal, lab work) is used. Special requirements for this application include the high emphasis on sample identification and classification, flexible and effective definition of sample type test plans, historic views of the data incl. statistical analysis, trend analysis etc.

Fig. 2: Web module request overview

WinLIMS™-Automotive highlights are • High level of integration of MS-Office

o Reporting with MS-Word via QSIReporter o Evaluation and graphics with MS-Excel o Emails with MS-Outlook o Integration with the enterprise address

• register with Exchange Server • Integration with enterprise authorization system • extensive use of the WinLIMS™ document

management system • modules for specific functionalities • a variety of technologically different interfaces

Fig. 3: Integrated MS-Excel reporting WinLIMS™ Features for the Automotive Industry Some of the Standard WinLIMS.NET™ Features that are provided by WinLIMS.NET™ that are traditionally embraced by the Automotive Industry include: • Role-based Security System • Version-Controlled Configuration Templates • Multiple Sample Login Options • Sample Tracking & Workflow • On-Line SQC/SPC Charting • Multiple Results Entry Options • Result, Sample and Product Review • Powerful Calculation Capabilities • Document & File Integration • Instrument Calibration & Maintenance • Integrated Reporting • External Web-Based Reporting • Inherently Multi-Lingual • Integrated Audit Trail • On-Line Documentation & Training Movies • User-Configurable Data Folders

WWiinnLLIIMMSS™™--AAuuttoommoottiivvee ffrroomm QQSSII

WinLIMS™ Optional Modules for the Automotive Industry Optional Modules that are specifically designed for Laboratories in the Automotive Industry include: • Instrument Interfacing • 3rd Party Integration • Customer Specification & Product Regrade • Formulation Management & Ingredient Ancestry • Batch Sequence (QA/QC) Testing • Used Oil Analysis and Equipment Tracking • Protocol-based Testing • Complaints & Corrective Action • Document Management • Materials Management • Multi-Site System Segmentation • External User Access Pages

Fig. 4: Request Manager Document Management In the automotive industry an enormous variety of different data from instruments is generated and needs to be filed and registered. At the same time reports to clients, certificates of analysis, invoices and many more documents of more textual character need to be managed. An effective tool for document management is therefore imperative for this type of application. WinLIMS™ document management system will hold information on SOPs, quality handbook, product specifications, lab reports, COAs, expert opinions etc. in a fully integrated, transparent form.

Fig. 5: DocMgr Document Overview

Its features include: • central repository for documents • safe and controlled access of documents • version control • status driven work flow, combines well with the • workflow module for

complex approval schemes

• multiple users on any document

• documents linked to any database object

• privilege system for user • complete audit trail • distribution lists • check in and check out • * no restriction on file

types: MS Excel, Word, HTML, BMP, JPEG, TXT, RTF, and many more

• accepted file types and/or max. sizes can be configured if desired

• key word engine for fast and easy searches

• preview mode for pictures, videos, docs

Fig. 6: DocMgr Thumbnails

Project Management WinLIMS™ has been developed with validated standard tools under a stringent quality assurance system. A comprehensive class library for many LIMS-specific functionalities is an integral part of WinLIMS, that is routinely used with any project. This results in a quick development while guaranteeing a high quality. To maximize the benefits QSI has developed a special project model as a modification of a variety of existing models, that combines the benefits of classic project models with those of object oriented, model driven ones. This results in a number of benefits: • little or no custom coding • quick project process • defined software status • updateable software • high quality Basically QSI project management follows the v-model. This ensures an excellent framework of milestones to transparently implement the project. Using this approach QSI has implemented hundreds of systems successfully within time and financial targets.

WWiinnLLIIMMSS™™--AAuuttoommoottiivvee ffrroomm QQSSII

Initially a site survey is carried out to define the functional and operating requirements of a proposed new LIMS. This involves the QSI consultant visiting the client site so that he or she can work with the LIMS project team to establish the LIMS requirements. Throughout the site survey process documentation will be produced, which will be reviewed at each logical stage. At the completion of the survey a complete specification will exist, written in plain English, detailing the LIMS functional requirements and the technical structure needed to provide the functionality. QSI cannot stress enough that this is the most important aspect of a LIMS project. QSI provides an implementation service which configures WinLIMS™ to meet the requirements of the agreed specification document that is derived from a Site Survey. The majority of the implementation work is largely cosmetic, covering the following aspects. Ensuring the underlying data structure meets the specification requirements. Editing of screen forms to reflect the data structure. Adjustment of field names. Adjustment of field tabbing order.

Some clients require additional functionality to be able to go live successfully. In these cases careful consideration is given to the creation methodology used. The other aspects of implementation carried out by QSI are the creation of required reports and instrument interfacing. Once WinLIMS.NET™ has been implemented to the clients needs, it is tested internally by QSI to ensure it meets the requirements of the specification document. Once it has passed QSI testing, the software is installed at the client site ready for acceptance testing by the client. During the acceptance testing period, fine tuning is carried out to the software, based on the client comments, until ultimately the client "signs off" the software as meeting the agreed requirement. Software Maintenance and Enhancement After the system acceptance by the customer WinLIMS™ is supported via Software Maintenance and Enhancement (SEAM) contract. The SEAM contains Telephone hotline support, bug fixing via Remote Access and software updates. If desired a 24-hours/7 days support contract with guaranteed response times can be made available.

Quality Systems International Quality Systems International is a leader in the supply of innovative LIMS (Laboratory Information Management System) software and associated consulting services, which together provide enterprise solutions for all laboratories. By the careful selection of new technologies in connection with experienced staff we let our customers participate at technological progress at all times in the optimum way. Quality System International maintains offices in a variety of different countries and can support its users perfectly: anywhere they want it. QSI is a company active worldwide with addresses in all important industrialized countries. The company has been established 1991. In 1993 the Client/Server based laboratory information management system WinLIMS™ has been introduced to the market. QSI now is one of the most successful globally acting LIMS companies. There are over 10.000 users world-wide using WinLIMS™.

Quality Systems International GmbH www.homepage.qsi.de email: info@qsi.de

QSI GmbH QSI Corp. QSI UK Ltd. QSI Pty Ltd. QSI BV Robert-Bosch-Str. 5 445 Godwin Ave. Carter House, Chilton The Atrium - Suite 9 Gewandeweg 5, 63225 Langen Midland Park, NJ 07432 Aylesbury, Bucks 476 Canterbury Road NL-6161 DJ Geleen Deutschland U.S.A HP18 9LS UK Forest Hill VIC 3131 The Netherlands +49 6103 9007 0 +1 201 251 2101 +44 1844 208 598 +613 9877 5588 +31 46 7501167