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