Matrix Gemini™ The Only LIMS to Deliver the Best of Both

Desktop Client and Web Worlds

Matrix Gemini™ is the World’s first fully configurable Commercial Off-The-Shelf (COTS) LIMS designed for any laboratory in any industry that delivers an identical user experience no matter whether you use a LAN, WAN or the Web. As soon as any screen is designed using the unique Matrix Gemini™ OneTime Configuration™ Tools, it is immediately available via your network or over the web, without further modification, effort or cost! Choose the connection to suit your situation and role; if you are out of your lab today, use the Web; back in your lab tomorrow, use a client on your LAN – Matrix does not mind! Just license the number of concurrent users that you need and connect whichever way is best for you. Unlike other systems that have “bolt on” web pages, older legacy code and esoteric, proprietary scripting languages, Matrix Gemini™ is developed using pure Microsoft .NET tools to deliver a LIMS for the 21st century so that you can move ahead with confidence. Today, laboratories are required to change their processes on a frequent basis. This is a challenge when implementing a LIMS unless the system is extremely configurable. However, until now there has always been a trade-off in choosing a LIMS – configurability vs. speed of implementation. Not any more. Matrix Gemini offers fast implementation and an excellent fit for a wide range of laboratories and processes.

Matrix Gemini™ is:

√ Better by Design √ Faster to Implement √ Easier to Use and Support √ Designed for Business Change

MATRIX LIMS

Key Features having to install the full application on each workstation, so reducing the burden on your IT group to install and support the application across many locations.

Matrix Gemini is an advanced Microsoft .NET, C# LIMS developed in the UK by Autoscribe Ltd., an ISO 9001 certified company dedicated to the LIMS and data management software business for over 18 years.

Matrix Gemini is unequalled in its configuration flexibility - easy to use configuration tools including a "configuration wizard" allowing free choice of screen and menu designs, customer specific tables/modules, multiple screens for the same function (e.g. registration screens optimised for each sample category), multiple sample numbering systems and much more. The flexibility of Matrix Gemini allows its use in a wide variety of laboratories, both in size and application. There are Autoscribe LIMS systems installed with over 500 concurrent users and also single user, single PC systems. Matrix Gemini is therefore suitable for both global organisations and small individual laboratories.

Web Browser Interface Desktop Client Interface

An identical user experience for LAN, WAN or the Web.

Matrix Gemini’s n-tier design allows you to install the application in such a way as to reduce traffic on your busy network, thus conserving bandwidth and improving response times.

Matrix Gemini – A Modern 21st Century LIMS

Matrix LIMS has the Best Configuration Tools Matrix Gemini is the latest member of the very

successful Matrix Product family that stretches back to 1988. Always innovative, employing the latest technology, Matrix Version 1 was the very first commercial LIMS to run on the then new “Windows®” operating system. It provided the easiest, most friendly LIMS available.

Powerful but very easy to use configuration tools have always been at the heart of Matrix success. This design is carried on with Matrix Gemini where the tools are even more powerful but usable by non-programmers. All laboratories have much in common. Samples are registered; samples are received into the laboratory; resources are allocated; tests are scheduled, raw results are entered, final values are calculated and may be compared to expected values, reports are issued and laboratory metrics may be published. Most modern commercial LIMS will provide this base level functionality.

Over the years, there have been several major rewrites of the Matrix family in order to take advantage of the latest developments in the “Windows” platform. Many existing users have migrated successfully through multiple revisions of Matrix and today enjoy all the benefits of a modern design, while accessing information that was entered in previous generations of the product.

However, each laboratory has some processes that are slightly different and how a commercial LIMS accommodates these differences is key to its success. The advanced Matrix design and the unique configuration tools allow each Matrix system to be tailored to the individual needs of each laboratory without the need to write custom extensions or scripts. Matrix tools are simple and easy to use – “drag and drop”, “point and click” no esoteric scripting languages to learn!

Because of the robust design, adherence to standards and ensuring that new versions are always backward compatible, some Matrix clients have successfully migrated through five generations of Matrix over 16 years with an excellent return on their investment! Matrix Gemini continues on this path, being completely rewritten using the new more efficient C# language, it is designed to take advantage of the benefits offered by the Microsoft .NET tools. It provides for the optimum implementation to match your network and your operational needs.

This configurable, commercial design offers the fit of a custom solution without the problems and costs of on-going support, documentation and upgrades associated with bespoke systems.

When a screen is designed using the unique Matrix configuration tools it can be immediately used on “rich client” workstations, “thin client” workstations and “web browser clients” without any modification. Now you can enjoy the proven benefits of the Matrix “workflow” interface on any Windows® device without

Matrix Gemini is: Faster to implement: no custom programs or scripts to write, test, validate and maintain.

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Easier to Use and to Support: intuitive menus and forms that use familiar nomenclature and graphics.

reference data such as test definitions and extensive features to help with 21CFR Part 11 compliance. e.g. data entry authentication and comprehensive password management capability.

Better by Design delivering Better Returns: easier and less expensive to support and upgrade, provides for longer useful life. Uniquely, we will support configuration changes that you make to your own system using the configuration tools, at no extra cost.

The system may be used with a variety of databases including Oracle and Microsoft SQL Server. Designed for Business Changes: Autoscribe has an unmatched reputation for professional system implementation and support services that may be verified with existing customers included on an extensive reference list.

Matrix Gemini can be easily configured by non-programmers to meet all required business changes. Matrix Gemini is also easily scalable across LAN, WAN and the Web to meet any future growth requirements. Matrix Re-defines Configuration: • OneTime configuration enables immediate

deployment of identical user interface across LAN, WAN and Web

• Unlimited choice of workflow and menu designs

• Optimized screens for every function (e.g. Multiple Registration screens optimized for each sample category)

• Customer specific tables and modules • Unlimited number of logical numbering

systems • Complete translation to your terminology • Unlimited group, role and user access levels • Choice of host database e.g. SQL Server,

Oracle • Easily scaleable from a single department

within a site, to a single user workstation Enterprise wide implementation at multiple sites.

Example Matrix Workflow Screen

“Our LIMS” becomes “your LIMS” very quickly

and easily! Matrix Gemini is Adaptable

Matrix Gemini is an ODBC (Open Database Connectivity) compliant system which will operate with a number of commercial databases to suit either corporate standards or user preferences. Different databases can be used for different departments within the same company, if so desired, as shown in the following diagram.

Your IT group and your laboratory staff will both benefit from choosing Matrix Gemini.

Matrix Gemini is Simple to Use Matrix Gemini includes several unique features which simplify its operation.

The unique Workflow user interface graphically represents the progress of a sample through the laboratory. Simply click on a selected step in the flow diagram and go straight to that LIMS function. This interface is more intuitive than conventional menus as it better represents the sequence of work in the laboratory. Moreover multiple workflow interfaces can be used and they can be individually configured to suit different work practices.

Matrix Gemini includes extensive features to assist with the requirements of the highly regulated laboratory including audit trails, time and date stamping of all actions, version control of all

Multiple Databases can be easily used with Matrix Gemini

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implementation. For example, in one laboratory a status of "Sample Prepared" may be preferred whereas in Another laboratory "Ready for Analysis" is better. This is easily achieved. The same translation tool also allows conversion of English to other languages and for global applications a mixture of languages can be used.

Sample Registration The key to a successful LIMS implementation is the design of the sample registration screens. Matrix Gemini allows all registration screens to be configured to suit individual user requirements. Multiple registration screens can be designed for different purposes within one system. For example, a laboratory dealing only with a small range of finished products will probably only require one sample registration screen. Laboratories dealing with raw materials, intermediates, complaint samples and competitor's samples, as well as finished products, will require a set of registration screens to provide the users with the most appropriate interface. This approach avoids screen design compromises and optional fields which can be very confusing. Key Functional Steps within Matrix Gemini

Samples may be registered in Matrix Gemini in a number of ways:

Matrix Gemini is supplied as standard with 3 separate database groups. Typically one is used for current/active samples, another for archived samples and the third for development and/or training purposes. Other databases can be added with no practical limit and one Matrix Gemini system can accommodate a mixture of commercial databases as shown in the above diagram.

a) single sample registration b) multiple sample registration allows identical

samples to be registered with one keystroke, each sample receiving a unique i.d.

c) batch registration allows the registration of

multiple samples, which may be identical, similar or completely different, within a batch. The batch is assigned a unique identity as is each of the samples registered within the batch. Samples may be added to a batch at any time after the initial registration of the batch allowing for situations where samples are taken and submitted for analysis over a period of time e.g. environmental studies. The terms job, project, sampling location etc. can be used instead of batch. For example, in a contract laboratory the term job may be the most appropriate.

Each database group in Matrix Gemini operates independently and can have a completely different configuration e.g. separate departments can optimise screens for their purposes rather than making a compromise. The scalability of Matrix Gemini allows it to be installed as a single-user workstation system, on a local network with a few users, or on a wide area network supporting multiple laboratories at different sites. Users may be assigned to specific database groups with different levels of access authority in each, allowing a single copy of Matrix Gemini to be used company wide.

d) template sample registration allows the

regular registration of a set of samples, identical or different, at manually selected times.

A translation facility (part of the configuration tools) is included in the system as standard. This allows suitable terminology to be used for each

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e) scheduled sample registration is similar to the template approach except that a schedule is defined and samples are then registered automatically according to this schedule. A very specific example is the use of the stability study management module with Matrix Gemini which generates samples according to a pre-defined protocol.

f) data transfer from other software systems used

within the organization e.g. document a and production systems, ERP / MRP / MES systems etc.

Samples are typically registered using a screen designed for the application – see examples below.

Sample Registration Screen for Food Products

New entries may be made in the submitter, customer and test tables without leaving the sample registration screen. Sample Receipt & Sample Preparation Sample receipt is used to record the physical receipt of the sample in the laboratory. This module can be useful where samples are pre-booked or registered outside of the laboratory e.g. within a plant. Single samples, multiple samples and sample batches may be received in one simple operation. When a sample is received, the status of the sample is changed automatically.

Sample Registration Screen for Raw Materials Sample registration, in whatever mode of operation, typically allows the identification of the sample submitter and/or the customer. In addition, the sample or product type can be identified that in turn allocates a pre-defined test suite to the sample for routine applications. Tests can be manually assigned to samples in non-routine environments.

The Sample Preparation function is useful as it ensures that only those samples ready for testing are included in work lists or transferred to sequence files in instrument data systems. The status of Sample Prepared is used to indicate that the sample has been correctly prepared ready for testing. Sample Preparation may be performed by batch or by sample as for Sample Receipt.

Sample and batch numbers may be manually or automatically assigned. One key feature is that multiple sample numbering systems may be used in Matrix Gemini e.g. for different work classes, laboratories and/or sites. Other fields in the registration screen can be used for sample attributes, descriptive information and dates as needed. In the latter case, date calculations are supported allowing automatic allocation of target completion dates and shelf life, for example. Bar code functionality is provided as standard and may be used throughout Matrix Gemini.

The status level termed "Sample Prepared" can be changed to suit end-user requirements e.g. "Ready for Testing" may be a preferred alternative. This is achieved using the translation functionality supplied with Matrix Gemini.

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Work Allocation Once samples have reached the ‘Prepared’ status they may be included on work lists which can be defined by laboratory, user, test, and/or instrument, for example.

e) colour coded responses and/or warning messages when results fall outside defined limits

f) comprehensive calculation support The movement of samples from one laboratory to another can be fully tracked using a chain of custody or resource tracking function. Bar codes can be used to identify laboratory locations if required.

g) rules for number of decimal places, significant

figures, rounding, truncation, scientific notation and more can be set individually for each cell.

The optional Runsheet function can be used to create a sequence file including blanks, standards and quality check samples. The sequence can then be kept together for manual result entry or be downloaded to a suitable instrument or data system. Each sequence is given a unique identification.

Test Results can be:

• Numeric Values (pH, temperature) • Numeric Values calculated from other entered

values (e.g. loss of weight on drying) • Menu Choices (pass / fail or white, off-white,

cream, yellow) On creation of a sequence using the Runsheet function the validity of the instrument (i.e. status of calibration and maintenance) and operator (i.e. appropriate training record) is checked prior to the commencement of analysis.

• Free Text Comments • Graphics An extension of the result entry screen design is a two dimensional spreadsheet available for entering and reviewing multiple tests across multiple samples (known as MSRE).

Result Entry Results are entered either manually or directly from instruments and systems connected to Matrix Gemini. Manual result entry is available on a sample by sample or test by test basis.

The screen, designed by the user for each test, provides a high degree of flexibility:- a) each test can consist of one or many

thousands of component or data cells b) cells can be defined for different data types e.g.

numeric, menu selection, text, date, time Multiple Sample Result Entry (MSRE) Screen

c) audit trailing is done at the cell or component Result limits may be simultaneously assigned and checked at the following levels:-

level

d) limits may be applied to any cells (see later) a) product level to check quality control

specifications, for example

b) product/submitter/customer level when, for

example, different limits are involved for different submitters/customers

c) test level for checking that entered results are

valid for the test e.g. pH not exceeding 14 d) sample level for adding limits for specific

checks as samples are registered e) stability limits which will be relevant when

Matrix Gemini is used with the Stability Manager module.

Multiple limits may be assigned at each level with

differing responses e.g. reject, failed, warning, according to the value of the entered result.

Test by Test Result Entry Screen

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Sample Approval Screen

atrix Gemini allows the use of rule based limits

esult import from instruments and systems is

atrix Gemini provides result validation and multi-

eporting Matrix Gemini also extends to the

he Explorer search function allows the entry of the

IMS Reference Tables in Matrix Gemini include

he test table, for example, will contain the

ull version control is available for each of the

plit-Screen Displays are much easier to use

LStandard reference tablessubmitter/customer, substance/product, test, user, instrument and laboratory resource. Many more may be added as required by the application. Each table may be configured in terms of allocated fields and user interface. Tdefinition of each test on the system including a unique code, a test description, test related limits (e.g. detection limit) and a screen design for the entry of results as described in a previous section. In addition, test times and costs may be entered and transparent access to methods is provided. Product specifications are also held on the system. These include an unlimited number of limits, target values, units of measurement and rounding rules.

Mwhich allow sample based logic to more intelligently assign limits e.g. if the clinical sample is from a male subject under the age of 10 apply Limit A or if the clinical sample is from a female subject over the age of 15 apply Limit B.

Ftables allowing the tracking of record changes by time, date, user id and the details of the revisions. Many revisions of each record can be stored. Each new revision will need supervisory approval before it can be used if this facility is activated in the system

Ravailable. Devices to be interfaced can vary from simple balances to comprehensive multi-channel chromatography data systems.

Sthan the conventional two-dimensional scrolling technique. Information such as project, submitter, batch, storage location, date promised, etc. is displayed. By clicking on a further command button, all the available results and the complete history of the selected sample are presented.

Mlevel sample approval stages that may be configured to suit the needs of a particular laboratory/organisation. RFlexibility in

reporting facilities. The reporting tool recommended is Crystal Reports although alternatives such as tools provided with the chosen database can be used. In all cases no programming knowledge is required to create reports. Instead, Matrix Gemini provides an easy user interface for selecting and positioning information that is to be included on reports. Any database or table field may be reported using any font supported by Windows™. Graphics may be incorporated into Matrix reports to ensure that all essential information is presented in a clear and concise format. In order to extract the correct data, Matrix Gemini reporting tools include a powerful query facility which allows users to extract data on the basis of any database field using a number of relational operators.

Easier to Use Split-Screen Displays

atrix Gemini enhances Productivity in every

he flexibility and scalability of Matrix make it an

oday there are users in many countries in the

• Analytical Services

er

Mindustry and every laboratory Texcellent choice for many types of laboratory. Tfollowing industries:

Tknown attributes of a sample, such as Date Registered, Customer Name, Project Number, Batch/ Lot Number, Product Type, etc. and Matrix Explorer “drills” into the database for all the relevant information, then presents the results in a split screen display.

• Biotechnology • Chemicals / Polym• Contract Analysis

• Food & Beverage • Material Testing

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cal anufacturing

ste Water

or certain specific types of laboratory we have

equest separate information on:

“Stability Express TK” for shelf-life testing of

“Neptune” for Water / Waste Water

“Rutherford” for Nuclear and Radiochemical

“SampleTracker” for Sample Tracking

“Feedback” for the tracking & resolution of

he extensive core functionality of Matrix can be

ctive Training Manager: actively assists in

vent Scheduler may be used to schedule

dule several management reports to run

• .00 AM

• panel of routine samples on the

requency Testing: is used to vary the tests

strument Calibration & Maintenance: is used to monitor and record calibration and maintenance

rts test roups enabling one or more tests to be

s can be used to anage processes and process steps e.g. sample

events for test equipment and instruments. Prevents tests being completed on “out of calibration” equipment and hence is very useful in regulated industries or as part of a Quality Management program such as ISO 9000 Process Steps: Matrix Gemini suppo

• Medical Devices • Metals / Mining • Nuclear • Petrochemi• Pharmaceutical M• Pharmaceutical R&D • Utilities

g• Water / Wa associated with a test group. The concept of test groupF

developed a base configuration that matches the common needs of that application. We use the Matrix configuration tools to provide the additional functionality that is different for each individual client.

mpreparation. In this example a number of steps may be involved in the preparation of a sample such as weighing a sample amount, extracting with a volume of solvent, adding a given volume of reagent etc. Each of these steps can be defined allowing entry of information, with date, time and user id stamps, as the step is completed. Limits can be applied to each piece of data that is entered in the same way as limits are specified for laboratory tests. The step order can also be defined which would be the case in this example.

R •

Pharmaceuticals & Food

•laboratories

•laboratories

• •

Customer Complaints, Compliments and Comments

Tfurther extended by adding one or more of several options to your Matrix license: Process Steps Example

The status o and each

dividual step can be monitored using an

Af the entire process recording and managing the training activities for

laboratory staff or for other departments. Can prompt when training courses are required and can schedule and record events with details of student participation.

inoverview screen and a variety of reports can be generated. Process Steps can be applied to any application that involves a sequence of actions, where confirmation of those actions is required. E

certain types of event to happen at a given time / date eg: • Sche

on the last Friday of the month. Run a sample backlog report at 1each day. Register a second and third Monday of the month.

Fassociated with a specific sample type at registration, depending upon the supplier’s history and the calendar. This is particularly useful in the QC of raw materials.

Process Status In

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tatistical Process Control charts (SPC) Charts

ed display Statistical Process Control charts (SPC)

ution of the same ata. This data is non-normally distributed because it

shown s a trendline in date sequence

s) for the ata. An error condition exists, which the software

s) for the ata. An error condition exists, which the software

tegrating Your Lab with your other Business ystems

fast paced world it is vital to be able to nk the laboratory to your other “Enterprise”

ve this tegration. Web services and XML provide a

offers a fully functional API that onsists of a complete suite of Active X objects

alled eneric Selector screens that can display

your other usiness systems in a simple and supportable

rehensive Regulatory Compliance

highly gulated and unregulated laboratories. Whether

S Matrix Gemini also permits screens to be configur to

using our unique OneTime Configuration tools. The following chart types are available: Distribution: the frequency distrib

d is random - the blue line shows the expected random

distribution given the data's mean and variance.

In S

In today’s

li systems, such that information can be shared between the lab and the rest of your business. Your modern LIMS must link easily and reliably to ERP, Accounting, Production, Inventory systems and more. Additionally, laboratories in different sites and countries must be able to share sample and test results and report them “globally”. Matrix Gemini offers several ways to achie

Trendline: a set of randomly generated data a in

standard method for the interchange of data between the LIMS and other systems. We publish the data access and business logic layers of Matrix Gemini – this provides an Application Programmer’s Interface (API) that is powerful and easy to use. Matrix also

c with full documentation for users who wish to write their own programs to read and write to the Matrix Gemini database in a safe and audited way. Finally, Matrix provides a class of screens c

X-Chart: the X-Chart (chart of the meandautomatically circles in red.

Ginformation resident in another system on a Matrix screen via an SQL query and ODBC. Matrix integrates seamlessly with

b way.

Comp

Matrix Gemini is designed for use in both re you must comply with cGLPs and cGMPs and

FDA 21 CFR Part 11 in pharmaceutical companies, NELAC and ISO 17025 in water testing laboratories or food testing or NAMAS / UKAS regulations, Matrix has the tools and design to help you comply.

R-Chart: the R-Chart (chart of the rangedautomatically circles in red. Three points lie outside of on standard deviation from the mean which the software automatically marks with yellow chart markers.

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atrix products are developed and produced in an

User Requirements s

We welcome Customer audits

Validation Services

est scripts are available for purchase that can be

or Matrix Stability Express, full IQ and OQ services

e work closely with several experts in validation of

Remember - “If it is not documented

usiness Partners

utoscribe Ltd. the developers of Matrix products

Crystal Reports from Business Objects for all

LimsLink from Labtronics to connect

JMP from SAS Institute for shelf life projections

f course we use both Oracle and Microsoft SQL

roven Implementation at a Fixed Price

e have an outstanding reputation for delivering

s each lab is somewhat different, each

equest details of our LIMS Implementation

Post Implementation Support

ompletion of the implementation phase of a

hen you call our support line you normally speak

Monthly eMail newsletter g

e shooting

ecurity and Audit Trails

ll Matrix Gemini users have a password controlled

atrix Gemini has been successfully validated to

ll activities relating to samples, tests, resources,

MISO 9001:2000 certified environment with full documentation available. A “life-cycle” process is used and the following items are available for review and audit for each release: •• Functional Specification• Design Specifications • Source Code • Test Scripts

Tused to execute IQ and OQ. Fare available. Wlaboratory systems and will be happy to consult with you on your exact needs

then it does not exist!”

B Aare experts in LIMS and associated products. They do not use their resources to create functionality that is “tried and tested” in another product. Instead they partner with the developers of these other products to integrate them as tightly as possible with Matrix. Hence we offer the following bundled products with Matrix Gemini: •

reporting needs

•instruments to Matrix Gemini LIMS

•and general statistical calculations and graphs relating to stability studies

OServer as our host database. P Whigh quality professional services that is unmatched in our industry. The results of our annual customer opinion survey support this statement. Before you make a decision on which LIMS to choose, we invite you to inquire of any of our customers as to their experience with Matrix.

Aimplementation is unique. However, in the course of many implementations over the years, we have developed and “tuned” a process that is well tested and documented to deliver your requirements on an agreed schedule, for a proposed price. RMethodology

Cproject is the beginning of your Matrix family experience. We always aim to provide you with the highest level of support for the lowest on-going cost of ownership. The unique design of Matrix along with the power of the tools allows us to exceed your expectation. For instance, any Matrix screens or reports can be emailed back to our support center for us to help you fix a problem or effect a change. Wdirectly with someone technical who can assist you directly - no being given a number and the promise of a call back! Other support activities include: •• Annual User Group Meetin• Scheduled training classes • On-line web tutorials and troubl S Aauthority profile. Matrix Gemini contains a function based, non-hierarchical security system that may be tailored to support the real-world working practices of your organization. All users must sign on the system using their system name and password. They are given access only to the database, screens, functions and information relevant to their authority defined on the system. Each user or group of users may be automatically assigned individual menus and screens relevant to their work. Moperate in the most demanding regulatory environments. Matrix Gemini facilitates compliance with the FDA 21 CFR Part 11 rule via the unique authentication feature of the system and the extensive password management feature. (See separate leaflet) Aprojects, suppliers and customers are flagged with a revision number, time, date and user ID. Furthermore, Matrix Gemini provides convenient, on-line access to earlier versions of reference information, including specifications and tests.

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or Further Information Contact:

UTOSCRIBE LIMITED

ark

ingdom

el: + 44 (0) 118 984 0610

k

F AWellington House Riseley Business PBasingstoke Road Riseley, Berkshire RG7 1NW, United K TFax: + 44 (0) 118 994 0611 Mail: matrix@autoscribe.co.ue

Website: www.autoscribe.co.uk