WinKQCL 4. Endotoxin Detection and Analysis Software

Transcription

1 WinKQCL 4 Endotoxin Detection and Analysis Software

2 Endotoxin Expertise Lonza s LAL endotoxin detection products have been available since the 1970 s. Lonza developed and commercialized the first FDA licensed endpoint quantitative LAL assay, QCL In 1981, the QCL-1000 endpoint chromogenic LAL assay gave the LAL-user the ability to quantify the amount of endotoxin in the test sample. With the acquisition of the PYROGENT gel clot LAL in 1986, Lonza strengthened its gel clot products offering. Lonza scientists continued to develop an easier and more sensitive quantitative method and in 1989, launched Kinetic-QCL, the kinetic chromogenic LAL method that revolutionized endotoxin detection testing. Lonza s WinKQCL software platform has supported the pharmaceutical industry worldwide for over 20 years. Quantitative methods such as the Kinetic-QCL assay generate significant amounts of raw data that require careful analysis before reporting can take place. Regulatory concern about the treatment and storage of key manufacturing data such as endotoxin test results, has led to several regulatory initiatives such as the publication of 21 CFR Part 11. Recognizing the importance that software plays in accurate analysis and reporting, Lonza has made significant investments in software, and has its own in-house development systems and programmers, dedicated to producing robust endotoxin detection software. In the 20 years since the first endotoxin test was run with the software onboard the Kinetic-QCL plate reader, test methods and software have seen significant advances. Lonza has recently developed an endotoxin detection method that does not rely on the horseshoe crab as the source of the raw material. Our PyroGene assay uses a recombinant form of the horseshoe crab s endotoxinsensitive Factor C. The PyroGene assay offers lot-to-lot consistency in an endotoxin-specific test that reduces our dependence on the horseshoe crab. This innovative, all-liquid chemistry has also allowed the development of PyroSense, Lonza s on-line instrument for monitoring and providing more control of pharmaceutical water systems. Our WinKQCL software has evolved in parallel to include these new methods and systems. Lonza is committed to putting the customer first. The WinKQCL 4 software was designed with you in mind, based on your needs and requirements. We invite you to explore the new features of WinKQCL 4 software. 2

3 Welcome to the Evolution WinKQCL 4 software is Lonza s industry leading endotoxin detection and analysis software. Created by our endotoxin detection software development team, the WinKQCL 4 software offers a fully-integrated solution for your quantitative endotoxin detection testing, data management and reporting needs. 21 CFR Part 11 Compliant WinKQCL 4 software meets 21 CFR Part 11 technical requirements for electronic records and signatures, audit trails and database archiving. Fully Supported WinKQCL 4 supports all of the endotoxin detection assays from Lonza including Kinetic-QCL kinetic chromogenic, PYROGENT kinetic turbidimetric, PyroGene recombinant Factor C, and QCL-1000 endpoint chromogenic assays. Compatible with readers from BioTek and Tecan, the WinKQCL 4 software allows the user to run all of the endotoxin detection tests typically run in the Quality Control laboratory: Initial Qualification RSE/CSE Inhibition/Enhancement Routine Speed, Automation and Efficiency For years, users have come to expect excellence from the WinKQCL software. Version 4 continues in this tradition and brings new features to enhance the user experience and data-handling capabilities. Navigate through the efficient user-interface and experience the flexibility of the Drag n Drop and SpeedFill features that enable analysts to work smarter and faster. Barcode-enabled sample and reagent entry simplifies your workload and can reduce errors. Designed with the end-user in mind, our powerful and flexible trending tool not only allows you to trend more than one product, but also presents the query functions, result reports and plot tables in one window. The ability to auto-select results can help managers make intelligent decisions with the click of a mouse. Global Reach WinKQCL 4 software has been internationalized to meet the growing, global demand for comprehensive, quantitative endotoxin detection and analysis by offering the multi-language userinterface choices of English, French, German, Italian, Japanese, and Spanish. WinKQCL software is an integral part of the PyroSense on-line detection system. In addition, WinKQCL 4 software integrates with the Tecan Freedom EVOware software allowing assay templates to be executed using robotic scripts for the PyroTec liquid handling system. The Evolution of WinKQCL Software 1.0 first released Windows version 2.0 single-user database on same computer, 21 CFR Part 11 compliant 3.0 full support of PyroGene rfc assay, client-server database, export records to LIMS 3.1 PyroSense module, database optimizations, audit log entries when assays begin 4.0 Enterprise system, interactive trending, enhanced user-interface, multiple readers, multi-language 3

4 Getting Started The WinKQCL 4 software has a redesigned user interface to help streamline your endotoxin detection testing. For someone new to WinKQCL software, the first step is setting up Analysts, Reviewers and Supervisors in the Tools menu. Each Role has specific functions and, therefore, different access within the software. Analysts can setup templates and run tests. A Supervisor serves an administrator role by controlling such things as user access, software setup and assay parameters. For users familiar with earlier versions of WinKQCL software, previously established users will still exist after upgrading to version 4. Ready to switch from the Supervisor to the newly setup Analyst? No need to exit the software. Simply click on the Switch User button to launch a new login. User Details The User Detail window is multi-purpose. It may be used to create, modify and view WinKQCL users. User access is restricted by unique User ID and password combinations, and the user s capabilities are dependent upon the role that has been assigned. Features Allows users to select language at login Ability to switch user that is logged on without exiting Supervisors can create and edit users and lock assay parameters Optional inactivity timeout reduces number of logins Application Tool Bar Tools Switch User Ability to set and change passwords Ability to assign roles Analysts and reviewers can apply their e-signatures displayed as text or bitmap image Select language of choice upon login 4

5 Simplified Instrument Management The WinKQCL 4 software has made instrument management an integral part of the software. As with previous WinKQCL networks, a Supervisor can review, edit or delete a reader configuration from any terminal in the network, including the terminal in his or her office. The WinKQCL 4 software intelligently checks for connected readers and their current status. Automatic Reader Discover and Temperature Setting The WinKQCL software automatically searches and scans all COM ports for previously set-up, powered-on readers. When a new reader is added, clicking the Discover button will trigger a search to find a new reader. Discovered readers are automatically added to the list and can be used immediately. In addition, the reader status check at start-up sets the correct temperature for all discovered readers. This feature provides the Analyst with a quick check before an assay is run and avoids delays waiting for a reader to come to temperature. More Choices. More Flexibility. The WinKQCL 4 software supports the BioTek ELx808 and FLx800 and Tecan Sunrise readers, offering the users more choices in microplate readers. In addition, the software can accommodate running multiple readers on a single computer. Simultaneous reading is possible through the multi-threading feature giving the Analyst smooth and seamless operation while running multiple tests on various readers. Features Automatic reader search and discover Simultaneous multi-reader control Reader multi-threading Supervisors and Analysts can add, edit and delete readers Status of readers Reader discover 5

6 Template Setup in One Window The WinKQCL 4 Template Manager has been enhanced to provide an improved operator interface. Everything is in one open, flexible window. The Analyst can Drag n Drop more than one product from a Master Product List to the Products table, which allows for easy and efficient template customization. With the SpeedFill feature, product entry is rapid, because repetitive fields such as dilution factor and PPC concentration can be automatically populated from one product entry to the next. This requires fewer key strokes and helps the Analyst reduce data entry errors. The SpeedFill feature enables near-instant addition of product data via a hand-held barcode scanner. The WinKQCL 4 templates integrate with the Tecan Freedom EVOware liquid handling platform for automatic plating and tracking of sample lot numbers. With the installation of a barcode reader, barcodes on sample tubes can be automatically imported to the template. Plates created on the PyroTec robot can be read at any WinKQCL workstation. Features Drag n Drop and SpeedFill features Preset standard curve history Smart concentration/dilution series calculator Automatic template message alerts Tecan Freedom EVOware integration Plate always visible Drag n Drop products onto plate Drag master products onto list SpeedFill mode to avoid retyping 6

7 Search & Display Whether you are searching the Products List to add products to the Master Products List or the Templates List to find the template you want to run, WinKQCL 4 software makes finding what you are looking for much faster. Clicking on column headers on many tables allows them to be sorted Refine search Do you want to find the tests that you ran? Use the Search/Filter feature to easily find all tests with Me as the analyst. Me as the analyst 7

8 Friendly Endotoxin Tests Results Viewer The Endotoxin Test Results window displays a printable report for a particular test. The results viewer opens with the ability to display not only the test selected from the Endotoxin Tests Results window, but also tests above and below the selected test in the list, to a maximum of 50, via the Previous/Next buttons. Controls to print/export Analysts and Reviewers can apply their electronic signatures with a click of a button. Records of the signature applications are stored in the Record Audit Log. When the signatures are applied, the Analyst and Reviewer have the opportunity to add signature comments at the end of the results report. Features All functionality available from Report Viewer Previous/Next buttons navigate between tests without closing report viewer Auto-export of endotoxin tests when complete into format for LIMS capture 21 CFR Part 11 Compliant for electronic records and signatures Analyst & Reviewer E-signature buttons Export to LIMS Easy navigation to Previous/Next available test 8

9 Interactive Trending The Trend View window allows for the generation of reports and graphs by querying existing test data in the WinKQCL database with user-specific criteria. All query functions, results table and plot are delivered in a well-organized, easy viewing window. Query and Analyze Using the interactive trending tool, a lab manager can click on a point in the plot to auto-select results in the table. Multiple product results, accessories and individual analysts results can be reviewed, compared and analyzed, on demand, delivering actionable data to your desktop so you can make intelligent decisions. By giving you the ability to plot customized control and sigma limits, WinKQCL 4 software will help you detect drift and catch potential Out of Specification (OOS) results before they happen, saving you and your Quality Control team time and money. Features All query functions, results table and plot display in one window Trend more than one product Customizable limits Actionable data delivered to your desktop Ability to export trending query results to Microsoft Excel Very flexible query builder; not limited to one product Right click to copy into other applications, e.g. Microsoft Excel Clicking on data point scrolls to location in results table One window shows query, as well as plot and table results Double-click on row to display test in Report Viewer New statistics section allows flexibility in drawing limit lines Ability to hide/unhide data points 9

10 Efficient and Secure Database Maintenance Supervisors can schedule the maintenance of the WinKQCL 4 database by selecting the Schedule Database Maintenance tool. Features include database backup, archiving records, and compacting the database. The system can schedule two backups, integrity tests, as well as defragmentation. To prevent a hard drive from filling up, WinKQCL 4 software gives you the option of overwriting old backup files. If an error occurs during maintenance, WinKQCL 4 can trigger an automatic warning message at the next login. For those users who have a licensed version of SQL Server 2005, such as Standard or Enterprise Edition, database maintenance can be scheduled to occur automatically. Features Shrink/compact database Set up two scheduled backups Automatic warning of errors in scheduled database tasks Overwrite existing backup files to avoid filling backup drive Set-up two scheduled back ups Schedule automatic database back-up Remove empty space from database Overwrite old backup files with new ones to prevent waste of disk space 10

11 System Requirements and Optional Accessories Standalone System Minimum Requirements for a Standalone System: Component Operating Systems CPU Memory Network Graphics Hard Drive Other Networked Client/Server System Minimum Requirements for a Network Client: Component Operating System CPU Memory Network Graphics Hard Drive Other Minimum Requirements for a Network Server: Requirement Windows XP Professional SP2 or higher Windows Vista Business or Enterprise SP1 or higher Intel Pentium 4 or better (2 CPU cores or more recommended) 2 GB minimum 10/100 or higher Network Interface Card or Microsoft Loopback Adapter Installed TCP/IP protocol, File and Print Sharing for Microsoft Networks, and Client for Microsoft Networks installed minimum, or higher recommended 4 GB or more available space *One free serial port for each reader. If a serial port is not available, Catalog # can be purchased to add one. Requirement Windows XP Professional SP2 or higher or Windows Vista Business or Enterprise Intel Pentium 4 or better (2 CPU cores or more recommended) 512MB minimum for XP, 1GB minimum for Vista 10/100 or higher Network Interface Card TCP/IP protocol, File and Print Sharing for Microsoft Networks, and Client for Microsoft Networks installed minimum, or higher recommended 1 GB or more available space *One free serial port for each reader. If a serial port is not available, Catalog # can be purchased to add one. Component Requirement Operating System Windows Server 2003 SP1 or higher or Windows Server 2008 CPU Intel Pentium 4 with hyperthreading or better (2 CPU cores or more recommended) Memory 2 GB minimum Network 10/100 or higher Network Interface Card TCP/IP protocol, File and Print Sharing for Microsoft Networks, and Client for Microsoft Networks installed Hard Drive 10 GB or more available space Other Microsoft SQL Server 2005 Standard license and installation CD, and associated client access licenses. *One free serial port for each reader. If a serial port is not available, Catalog # can be purchased to add one. Optional Accessories The following table lists optional accessories (may be required to perform tests and print test reports): Accessory Power Backup Printer Cables Microplate Reader(s) PyroSense Instrument PyroTec Robot Description 600VA or higher recommended for all servers and systems with readers attached USB, parallel, or network printer PC to printer PC to microplate reader PC to PyroSense instrument The following microplate readers are supported: BioTek ELx808 IU or RIU Absorbance Reader BioTek FLx800 Fluorescence Reader Tecan Sunrise Reader PyroSense On-Line Endotoxin Detection System Tecan Freedom EVO 150 Liquid Handling System Robot * If multiple serial ports are needed in order to connect two or more readers to the computer, a PCI or PCIs serial port adaptor card with multiple serial ports will provide more stability over mutiple USB-serial port adaptors. Serial port cards using the UART chipset are recommended. 11

12 Ordering Information Name/Description Part No. WinKQCL 4 Software Package CD, Software Manual and License Agreement* WinKQCL 4 Standard License Agreement Additional License Agreement* WinKQCL 4 Qualification Manual IOPQ for Endotoxin Detection Systems WinKQCL 4 Validation Package CD containing software validation documentation System Qualification Service Labor expenses only S Instruments Supported by WinKQCL 4 Software Name/Description Part No. ELx808 Absorbance plate reader Sunrise Absorbance plate reader FLx800 Fluorescence plate reader PyroTec Liquid Handling System Please inquire PyroSense On-line Endotoxin Detection System WinKQCL 4 Intelligent Endotoxin Detection Software WinKQCL 4 software, developed by Lonza s endotoxin detection software development team, delivers an open and flexible, multi-language user interface, powerful, interactive trending tools and seamless and secure database management. WinKQCL 4 software is an enterprise solution that fits all application sizes from standalone to global networks. Experience the Evolution. * License agreement includes license to load software on all computers connected to one WinKQCL 4 network database and to connect to one instrument. Each additional instrument connected to the network that communicates with WinKQCL software will require an additional license.

13 Contact Information North America Customer Service: Scientific Support: Online Ordering: Europe Customer Service: 32 (0) Scientific Support: 32 (0) Online Ordering: International Contact your local Lonza Distributor Customer Service: x 2322 Fax: scientific.support@lonza.com International Offices Australia Austria Belgium 32 (0) Brasil Denmark France 33 (0) Germany India Italy Japan The Netherlands Norway Poland Singapore Spain Sweden Switzerland United Kingdom Lonza Walkersville, Inc. Walkersville, MD Excel, Windows, Windows Server, Windows Vista, and SQL Server are trademarks of Microsoft Corporation. Intel Pentium is a trademark of Intel Corporation. ELx808 and FLx800 are trademarks of BioTek Instruments, Inc. Sunrise, Freedom EVOware and FreedomEVO are trademarks of Tecan Group Ltd. Unless otherwise noted, all trademarks herein are marks of the Lonza Group or its affiliates. The information contained herein is believed to be correct and corresponds to the latest state of scientific and technical knowledge. However, no warranty is made, either expressed or implied, regarding its accuracy or the results to be obtained from the use of such information and no warranty is expressed or implied concerning the use of these products. The buyer assumes all risks of use and/or handling. No statement is intended or should be construed as a recommendation to infringe any existing patent. Copyright 2009, Lonza Walkersville, Inc. All rights reserved. BR /09