Overview
Transcription
Overview
Overview Quality Systems International is the world's leading innovator in LIMS (Laboratory Information Management System) software. Our WinLIMS software is used in over 800 organizations throughout the world to add productivity and savings by optimizing the flow of information to and through the laboratory. WinLIMS contains a wealth of functionality which has been developed based on the actual requirements of our extensive user base. As our clients are from all sectors of industry, we have created functionality specific to each industry, so that WinLIMS can supply a complete solution to any company requiring a new or replacement LIMS. It is virtually impossible to document the systems functionality in a comprehensive way in a 4 page brochure, therefore we will focus on a number of basic functionalities and give some insight on a few more advanced techniques. This is by no means a complete list of functionality, QSI staff will be happy to demonstrate the system in it’s entirety, making sure to stress the solutions that are important to you in your environment. WinLIMS is designed to be completely customer configurable, not only providing a wealth of configuration switches, but also offering a powerful screen designer tool for the most sophisticated forms according to your needs and the compelte power of MS Visual Studio at your finger tips, all without a need to touch source code and/or recompile the package. That defines a new unrivalled power in adapting customer requirement while at the same time maintaining a validated system, easy to update and easy to upgrade. The combination of sophisticated database technology with modern 21st century programming techniques provides many unique features, like e.g. the use of proper chemical formulas with sub- and superscripts and may more. In combination with powerful document management there is no need to compromise any more. Single Sample Login Request Login Single sample login enables users to register a single sample. The registration process allows the user to identify a sample using your site-specific naming convention and automatically assign tests and their product-specific limits (if desired) using simple point and click operation and by applying your company's business logic. This tool is designed for use within analytical service and research laboratories where Requests (Jobs, Submissions, Incidents, etc.) are submitted that include one or more samples and need to be organized within a related data set. Requests can also be associated with Projects to incorporate a structure that makes data review and reporting both logical and efficient. Batch Sample Login Sample Scheduling Provides a means for registering multiple samples that are associated with the same production batch (or lot) within a single web page. This is a convenient tool that provides fast sample registration, data editing, results entry and data review in high volume environments. Within many laboratories samples are taken from production and/or environmental monitoring sites on a routine basis that is based on a time schedule. The WinLIMS automatic sample scheduler provides a simple table entry tool that allows you to identify the sample(s) to be taken, the time period, the time basis (minutes, hours, days, weeks, months or years) along with other descriptors. When the appropriate time is reached, the sample record is created and is assigned the workflow status of "Logged Pending Receipt". Labels and/or worksheets can be printed and the pick-up can be made available to web-enabled devices (such as iPhones) or downloaded to standalone devices to provide an accurate and dynamic pick-up list for inplant or off-site samplers. Barcode Label Printing / Sample Receipt Barcode labels can be printed automatically upon sample login, sample receipt or on-demand. The labels can include any of the sample's descriptors and can contain both human and machine readible (e.g. barcode) fonts. Logic can be built into WinLIMS to print the appropriate number and style of lables to accommodate "splitting" samples on the basis of your distribution requirements (e.g. by lab, by test, by storage conditions, etc.). For receiving a sample a barcode label containing the sample’s unique identifier would simply be scanned, to confirm receipt in a quick and efficient manner. Results Entry Labs vary widely in the way they prefer to enter results. WinLIMS therefore has a very powerful tool for entering results, by work order, by batch, by sample, by method, by crosstab. The user can switch between the different modes just by clicking with the mouse. charts from this page to provide accurate and immediate decision-making using the most up-tothe-minute information. By crosstab: when it is desirable to view results from a number of related samples within on page. Results Entry by Crosstab allows the user to select the identifiers that associate a number of samples. Upon making the selection, the results of all of the related samples will be presented on the form in a cross tabular fashion for data review and/or results entry. Instrument Interfaces access. Interfaces to analytical equipment (GC, HPLC, AAS, ICP, etc.), ERP-Systemen (SAP ERZ, E-Business Suite, Navision etc.), process control systems and practically any other data source can be built conveniently and safely, with a minimum of time and resource. WinLIMS is using this tool extensively in it’s certified interface for SAP ERP using Netweaver technology. Interface for SAP ERP™ The interface for WinLIMS and SAP ERP using the SAP NetWeaver Exchange Infrastructure (XI) has been certified by SAP May 26 2008. For that the QMIDI Standard-Components of the QIRF series were integrated, because of the power of this new technology interfaces using different, even custom built function modules can be established easily and safely with a minimum of effort. Statistical Graphing By sample: view all of the sample information while entering analytical results. Laboratories use this mode of results entry when it is beneficial to have a full perspective of the sample being tested at the time of results entry By method: select a specific test method and be instantly presented with a spreadsheet-like page that contains all samples for which results for the selected test have not been entered. You can instantaneously retrieve statistical information and The WinLIMS Bridge External Interface API is a generic tool for bidirectional interfacing with instruments and host computers running e.g.SAP ERP. The Bridge can work via file transfer (XML, CSV, XLS, TXT, etc.) or direct database Statistical graphing is available within WinLIMS. For example when reviewing a sample the user can highlight a result parameter and click the SQC button and the results for the measured parameters (analytes/ characteristic) will be presented within a graphical display to quickly identify trends. The display also presents the statistical information (mean, standard deviation, control limits, Cp, CpK values, etc.) that is commonly used by laboratories. Results Validation In many laboratories it is standard operating procedure to require results that were entered into WinLIMS to be reviewed by a peer or a supervisory staff member. This is often the case within pharmaceutical, food or any other regulated laboratory. When this level of data review is not required, or if data is only reviewed when it does not meet its specification requirements, the results validation step may be bypassed. Importantly, with the multi-lab option installed, the Visual Designer lets you create different forms with different controls and layouts for every lab involved. The Visual Designer is a true WYSIWYG tool. It supports the creation of controls like Tab Pages, Tab Controls, Check Boxes, Combo Boxes, Text Boxes, Labels, Data Grids etc. A unique technology creates the database objects needed Approval by Sample or by Batch The sample approval step is used to confirm that the sample's testing cycle has ended and the laboratory management has given the sample a final disposition. The disposition of samples will differ from lab to lab; however, most laboratories assign disposition statuses, which include Approved, Rejected, Reworked, Cancelled, Concession, etc. This lets the rest of the organization know what was determined by virtue of the laboratory's testing of the sample. Where companies process batches such as raw materials or manufacturing orders, batch approval routines exist to attach final disposition statuses. The final disposition would be based on the results of all the samples attached to the batch. Report Generators/COA QSI recommends and provides integration for Crystal Reports due to its ability to work with all of the WinLIMS supported databases, its powerful functionality and its affordable price. For many purposes the combination of WinWord and Access, as provided by the QSI Reporter, is ideal, as it not only allows flexible reporting from the database but also adding e.g. expert opinions etc to the document. In conjunction with the document management system this creates a powerful integrated solution. WinLIMS can work with a variety of report generators. Currently the report writers that are being used with WinLIMS™ include Birt, IQ Objects, Business Objects, Access, Report Windows, Report Smith and more. Visual Designer The WinLIMS Visual Designer is a tool for creating the form layout as required by the customer. It not only allows you to rearrange the items on the form, it comes with a complete toolbox for new controls, setting attributes etc. The Visual Designer can be used to create new forms altogether or modify existing ones. automatically and lets you test the form. It can then be used immediately, no need to re-compile or re-start the system. Importantly, these customizations of forms is totally independent from the system kernel, therefore they will be maintained on updates and upgrades, protecting your investment. Dynamic Code The Dynamic Code Editor allows you to create handlers for events of controls on forms. This could be the event TextChanged on the control CONTACT on the ADDRESS application. The handlers can be VB.NET code, Sql commands, external programs with proper parameters etc. Another example: using the Visual Designer you create a new pushbutton and of course you want some code to execute on it’s Click event. The Dynamic Code Editor can be configured to use your favorite development environment. If you choose MS Visual Studio, you work in a framework with complete access to the entire QSI namespace objects via Intellisense: coding was never simpler, some instrument interfaces e.g. can be reduced to a single line of code. Once tested your Dynamic Code can be used immediately, no need to re-compile or re-start the system. Importantly, all codes are totally independent from the system kernel, therefore they will be maintained on updates and upgrades, protecting your investment. Electronic Laboratory Notebook The WinLIMS ELN serves as a container for all kinds of information, typically one that may not be as well structured as the typical LIMS information. Users can create as many notebooks with corresponding pages in it as deemed necessary. If a notebook is shared, all users with the proper privileges can access the notebook for reading. The page contents can vary widely, it can hold notes, tables with data, chromatograms etc. Every single page can be digitally signed, validated and approved, making the information secure so it can serve as evidence in court. Importantly WinLIMS ELN links to regular WInLIMS data and vice versa, so there is no need for duplicate entry. Document Management Effective document management is an essential functionality for many application areas and a part of daily routine: documents for SOPs, QM manual, product specifications, COAs, expert opinions etc. WinLIMS document management system gives you a powerful, fully integrated solution. Just a few highlights: central document repository, secure and controlled access, version control, status driven, ideal with the Workflow module for multi-stage approvals, any number of editors for a document, complete audit trail, distribution lists, documents can be linked to any database object (orders, samples, tests, etc.), keyword search engine, preview mode for pictures, documents,video clips etc. WinLIMS Wiki The Wikipedia project has spawned a new class of software products altogether, the so called Wikis. They allow to quickly and easiliy generate electronic articles that can be filled with any type of information. The articles are stored under version control and can be searched for keywords. The Wiki used by Wikipedia itself is called MediaWiki and is available as an Open Source package. The WinLIMSWiki is an application using MediaWiki that has been fully integrated WinLIMS. It comes preconfigured with a complete help system that can be modified and extended by the users to become a custom help system, tailored to the needs. In addition, WinLIMSWiki allows to link articles to WinLIMS database objects like orders, samples, methods, etc. This results in a completely new quality for data representation in a LIMS: it is now possible to store and retrieve information that is poorly structured, combining the best of two worlds: the highly structured, well organized and performant approach of WinLIMS and the flexibility of a Wiki system, designed to be as generic as possible. General Functionalities WinLIMS has a number of functionalities that are available on every form. Space limitations only allow a short summary: Query the database Standard Query - a personalized std query Where Query- build your own, complex query QBE – query by example on all fields of the table Order by – select your favorite sort criteria Tree view – show records in a tree Save/Load Query – save a query for reuse Smart Search – enter your text and find all occurrences in all tables and documents Audit Trail and Security A complete, unlimited depth audit trail is written on all tables automatically. It will even document database updates performed by external tools accessing the database directly. In addition we store a hash code for every record generated by WinLIMS, allowing us to verify the data integrity and identify external manipulations. Electronic Records and Signatures This option can be configured to define variety of different objects to be electronic records in the definition of Title 21 CFR Part 11. These objects then require an electronic signature for specific actions within WinLIMS, from approval of methods and sample types via result entry to printing of COAs. Digital Signature While WinLIMS meets all the criteria of Title 21 CFR Part 11 for closed systems and provides a comprehensive mechanism for electronic signatures, it also has all the controls for open system operation requiring digital signing of documents using the built-inb state-of-the-art support of Microsoft’s DotNet Framework. WinLIMS has a comprehensive set of functionalities to generate and securely store private keys for signature and maintain and distribute public keys for signature verification. Any type of document can be configured to require a digital signature. 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 in the technological process 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 GmbH Robert-Bosch-Str. 5 63225 Langen Deutschland +49 6103 9007 0 www.qsi.de QSI Corp. 445 Godwin Ave. Midland Park, NJ 07432 U.S.A +1 201 251 2101 www.qsius.com QSI UK Ltd. Carter House, Chilton Aylesbury, Bucks HP18 9LS UK +44 1844 208 598 www.qsiuk.com QSI Pty Ltd. The Atrium - Suite 9 476 Canterbury Road Forest Hill VIC 3131 +613 9877 5588 www.qsiaus.com.au QSI BV Gewandeweg 5, NL-6161 DJ Geleen The Netherlands +31 46 7501167 www.lims-software.nl