LabWare - LIMS - Laboratory Information Management System

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LabWare - LIMS - Laboratory Information Management System

LabWare LIMS is a full-featured, configurable, enterprise Laboratory Information Management System (LIMS). Our architecture combines the power and security of an enterprise server with the ease of use provided by a dynamic graphical user interface. LabWare LIMS is designed to be completely customer configurable, providing an unparalleled degree of client involvement in adapting the software to their specific needs.

LabWare LIMS is a scalable architecture and has a proven track record both in decentralized and centralized, global enterprise installations. This architecture simultaneously encompasses diverse requirements, multi-lingual support, and high level security across many different time zones and applications. The LabWare LIMS client runs on any contemporary Microsoft Internet Explorer or Windows variant. Our web server component may be any J2EE web server, including those available as open source. The database server component may be installed on anything from Windows to UNIX to Linux, and may utilize any relational database from Oracle to SQL Server to DB2.

LabWare ELN is an experiment and workflow driven software application designed to give the laboratory scientist the ultimate platform to electronically document their experiments including relevant scientific content and observations, instrument results, and attachments such as spectra, chromatograms and, if appropriate, chemical structures. LabWare ELN works seamlessly with LabWare’s flagship product, LabWare LIMS, allowing any data within LIMS to be accessible by ELN and vice versa. Integrating ELN products from different suppliers has significant practical challenges and limitations, and very often requires the creation of a customized interface to achieve even simple data exchange between ELN and LIMS. The benefit of LabWare ELN is the inherently elegant interface that exists between the two systems and the simplicity by which both LIMS data and LIMS functionality can easily be shared and leveraged from within LabWare ELN.

Lab and Info Management

LabWare LIMS is fully compliant with the ASTM's Standard Guide for Laboratory Information Management Systems (LIMS) E-1578-93 and has all the functions and features to make your laboratory productive, efficient and compliant.

LabWare LIMS has many built-in frameworks for standard laboratory operations. These frameworks can be tailored to your needs without time consuming customization. Our emphasis is on empowering the customer to control their own destiny without requiring direct intervention by LabWare. It is the powerful functions and features of the system that make this possible.

Product and Process Management

Quality assurance testing of manufactured lots from the time raw materials are received, through the production process, and final inspection is the role of QC LIMS. LabWare LIMS has several features and modules designed specifically for product and process management.

Lot Manager is where the physical view of manufactured materials integrates with the laboratory's sample centric view. Samples of the physical materials are tested using sampling plans, specifications are checked, dispositions made, and Certificates of Analysis are generated. Lots can be split and combined with full traceability and genealogy.

  1. In process samples can be automatically scheduled by LabWare LIMS using one of the three process schedulers:
  2. Frequency based with even increments during defined time periods according to a day-of-week schedule.
  3. Calendar based where each day has its own schedule.
  4. Process unit based scheduling according to specified times for various sampling points.

Whether samples are batch oriented, or from a continuous process, they can be compared against product specifications. LabWare LIMS has a sophisticated, multilevel, product specification model that has been used to implement product specifications from all types of industries.

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Workflow

What is Workflow?

The automation of a business process, in whole or part, during which documents, information or tasks are passed from one participant* to another for action, according to a set of procedural rules.

*participant = human or machine

In the context of a laboratory the tasks mentioned above are achieved with LIMS. These include logging in samples, assigning tests, preparing samples for analysis, assigning samples to analysts and instruments, recording results, the results approval process and reporting.

In LabWare LIMS there are various managers and mechanisms that play a part in this process, and they may be categorized into three types:

  • Managers that group samples together for processing in a certain way.
  • Events that initiate and carry out the various status changes that move samples from stage to stage in the process.
  • Mechanisms that record what has taken place and when.

The various managers are described in detail elsewhere and the main ones are:

Folder Manager, Project Manager, Lot Manager, Batch Manager, Investigation Manager, Evidence Location Manager and Worksheets.

The events and mechanisms that can be used to initiate and perform the movement from one process to another are:

Event Triggers, Actions, Business Rules, Analysis Rules, Status Rules, Automation Scripts, Bar-codes, Schedulers and manual intervention.

Mechanisms that record what has taken place include:

Audit Trail, Chain of custody, Investigations, Evidence Movement, samples, tests, results, projects, lots, batches (these last six record various key dates and times and responsible persons).

These tools together make it very easy to define workflows of varying complexity and suitability, including those that have time-based dependencies (schedulers, actions) as well as those that are event driven.

While workflows can be used to control the progress of samples through the system very strictly, it is important that LIMS is not totally inflexible in case unanticipated exceptions occur. The comprehensive audit facilities included with LabWare LIMS will ensure that, when they do happen, any deviations will be thoroughly recorded ensuring full traceability.

The following example shows a typical example showing many of the features of workflow available in LabWare LIMS.

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In this scenario we see a sample logged in by one of the schedulers with an initial status of unreceived and a location at reception. When the sample is logged an analysis rule kicks in that adds a test that is required to complete the calculations in one of the other tests.

The folder at reception is set up to contain unreceived samples and the clerk acknowledges the receipt of the sample. This sets off an event trigger which prints a barcode label and sets the location to sample preparation. When the clerk's folder is refreshed (automatically or manually) the sample will no longer appear in the folder. The folder in sample preparation contains samples that have a status of received and a location of sample preparation. So when this folder is refreshed the sample from reception will appear. Here, when the sample is scanned by the operator, an action is initiated which tells LIMS that sample preparation has begun. In this case the preparation requires several hours in a drying oven and at the end of this period the action sends an alert to the operator and changes the location to the laboratory.

Once again the sample will disappear from the folder. This time it will appear automatically in batches for three different analyses. After the first results are entered the status is changed to in progress. After the first two tests the results are in specification, but in the third test results are out of specification. This triggers an event that creates an investigation on that sample and alerts the lab technician who decides to retest the sample. This time the results are in specification and the location is changed so it will appear in the lab manager's folder.

The lab manager then approves the results and an event trigger changes the location again, this time to the QA manager for final release. This causes a further trigger that produces a report which is sent back to the plant and changes the location to sample retention.

Here the clerk uses the inventory manager to record the storage location in the sample retention store.

A complete audit trail is recorded tracking everything that has happened to the sample.

Reporting

LabWare provides a comprehensive suite of reporting and data mining tools for publishing your LIMS data in a variety of presentation quality formats as well as exporting data to third party applications in compatible file formats. Reporting is perhaps one of the most significant functions in LIMS, therefore LabWare has gone to great lengths to seamlessly integrate the World's leading reporting tools directly into LIMS so that they behave as native LIMS functions.

The primary reporting tool in LabWare LIMS is Crystal Reports. The Crystal Report Designer application is used to graphically layout the format of the report by dragging and dropping fields from the LIMS database onto the visual report page. The criteria for selecting specific records from the LIMS database during reporting is a capability provided by LabWare LIMS called a Query Tag.

A Query Tag is simply a mechanism for allowing the report to be reused with a variety of LIMS records by displaying standard LIMS dialogs that prompt the user for information as the report is being generated at runtime.

When the report is generated, a WYSIWYG Preview window is displayed by LIMS allowing the user to view the report on-screen without the need to print it on paper.

Example of a LabWare Crystal Report for a Sample

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Regulatory

LabWare LIMS is designed from the ground up with the regulated industries in mind, such as the Pharmaceutical and Environmental industries. In order to achieve this, LabWare LIMS has needed to comply with all applicable regulatory guidelines and rulings, such as GMP, GLP, GCP and others (generally grouped together as GxP). In addition, we have ensured that requirements in other regulations such as 21 CFR Part 11, ISO 17025 and various national rulings are completely covered within LabWare LIMS.

LabWare has taken all of the applicable requirements and made sure that all of the possible technical controls are included within LabWare LIMS. For example, 21 CFR Parts 11, 50, 58, 210 211 and 820 are fully addressed within the LabWare LIMS solution. This is also the case with regional bodies such as Europe's EMEA and national bodies such as the Japanese MHLW.

A key element to regulatory compliance is that LabWare LIMS is a fully validated system within our customers' sites. We accomplish this by adhering to the concepts within Good Automated Manufacturing Practices. GAMP defines categories of software that affect the amount and depth of validation work that the customer should perform. LabWare LIMS qualifies as a Category 4 application, as it is a configurable system, where customization is not necessary.

In order to help our customers reach the right level of validation, LabWare provides extensive material such as:

  • Example Validation Plans
  • Automated Installation Qualification (IQ)
  • Operational Qualification (OQ)
  • Examples of Performance Qualification (PQ)
  • Examples of System Administration SOPs

LabWare will remain at the forefront as new regulations emerge, by having a very active involvement with both customers and regulators. LabWare frequently presents at international conferences and runs training seminars on the issue. LabWare LIMS includes several features designed for regulatory compliance, such as Analyst Certification and Business Rules. These features have value even for customers who are not regulated, because it introduces useful security concepts for any lab.

Stability and Inventory

LabWare LIMS is designed to completely manage Stability samples and their associated studies, all the way from the Protocol Design stage to the Study Completion stage, and every step in between.

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System Interfaces

One of the key benefits identified by our customers is the ability to interface LabWare LIMS to other systems within the company. LabWare has an excellent track record of successful bi-directional interfaces, both to other vendor solutions as well as to in-house systems.

LabWare LIMS has been integrated with many other business systems including SAP R/3, BPCS, Movex, and JD Edwards among others. In addition to ERP systems, we have integrated to a wide range of other process control systems, MRP, planning, accounting packages, mail systems and productivity packages. Many of these systems are proprietary in-house systems that need integrating into the LIMS environment.

Some of the features that facilitate system-to-system communication are:

Import / export - A standard import / export utility allows automatic sample login from external systems or exchange of information. This utility uses XML and CSV file formats and can be easily configured using a standard spreadsheet editor.
Event Triggers - Any activity can be initiated from a trigger that allows a routine to be executed that will export data to an external system.
LabWare LIMS can read and write to the databases of external applications, so in many cases it is not necessary to do much configuration on the other applications' side.
Scheduled events, such as reports, sample login and LIMS Basic routines can be predefined and then run based on a schedule.

LabWare LIMS provides extensive interfacing capabilities with other systems to allow for information to be shared between systems and not have to be manually re-entered.

The capabilities that can be utilized for interfacing include the following:

  • Files (XML, CSV, etc)
  • Database Tables
  • Dynamic Data Exchange
  • Mail Messages
  • RS-232 Serial Communications
  • Import / Export Files
  • Dynamic Link Library
  • External Program Execution
  • LabWare LabStation
  • FTP
  • TCP / IP Sockets
  • OLE Automation, ActiveX

SAP R/3 - LabWare LIMS has a SAP-certified interface with SAP R/3's QM module, following an interface specification called QM-IDI. This interface is enabled on both the SAP and LIMS applications. Additionally other transfer mechanisms can also be utilized to provide seamless integration as required.

Waters Millennium32 and Empower - LabWare are a premier partner of Waters and provides a direct interface between LabWare LIMS and Waters Millennium32 / Empower Chromatography Software, which has been designed using the Millennium Toolkit. Using the interface, scientists can remain within LIMS while performing most common chromatographic workflows such as assigning LIMS samples to run sequences, monitoring real time data collection, and reviewing and approving processed results before they are committed to the LIMS database. Regulated laboratories needing to comply with the FDA's 21 CFR Part 11 ruling are major beneficiaries because the interface is validated and provides seamless exchange of electronic records without generating any disk files. The interface leverages the built-in security and audit trails in both LabWare LIMS and the Millennium32 / Empower software and can be configured within minutes.

Microsoft Office products - LabWare LIMS can create native Microsoft Word documents and Microsoft Excel spreadsheets, without going through an interim format such as RTF and CSV files. It is also possible to create reports by opening Microsoft Word and / or Microsoft Excel and 'tagging in' the desired LabWare LIMS data.

Microsoft Exchange and Lotus Notes - LabWare LIMS provides full compliance to the MAPI and VIM standards, and hence can be used to automatically e-mail reports, as well as warn appropriate users of Out of Specification results.

Major systems interfaced include:

  • BaaN
  • BPCS
  • JD Edwards
  • Movex
  • Optiva Formulation System
  • Oracle GEMMS & Financials
  • PI
  • PRISM
  • SAP
  • Various In House systems

Financial and Commercial

Commercial laboratories often have hundreds, if not thousands, of customers. LabWare's Contract Lab Module is a fully integrated, special purpose, CRM (Customer Relationship Management) system designed for commercial laboratories. Some highlights include the ability to associate customer locations, people, and special testing, reporting, and notification requirements. The module also includes a Contact Manager for tracking calls and customer interactions.

LabWare LIMS Charge Manager handles sophisticated quotation and pricing schemes, with volume discounts and one-time charges. Invoices are automatically generated and snapshot views like 'work performed to date' are available. Tax plans and currency conversions are fully supported.

Configuration

More than anything else, LabWare LIMS is a configuration driven system. The emphasis is on 'options' that do not limit the way the system works. Solution frameworks are available that are tailored to your company's way of working.

Many of these 'frameworks' are referred to as 'managers' within the system. Each implements a solution paradigm that is configured by settings, switches and event triggers that are all stored in the database.

LabWare, Inc.
LabWare, Inc.
3 Mill Road, Suite 102
Wilmington ,  DE 19806

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