The Only LIMS to Deliver the Best of Both Desktop Client and Web Worlds

Transcription

1 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 21 st 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

2 Key Features 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. 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 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. Matrix Gemini A Modern 21 st Century LIMS Matrix Gemini is the latest member of the very successful Matrix Product family that stretches back to 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. 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. 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 LIMS has the Best Configuration Tools 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. 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. 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 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! 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. Matrix Gemini is: Faster to implement: no custom programs or scripts to write, test, validate and maintain. MGV1 Page 2 of 11

3 Easier to Use and to Support: intuitive menus and forms that use familiar nomenclature and graphics. 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. Designed for Business Changes: Matrix Gemini can be easily configured by nonprogrammers to meet all required business changes. Matrix Gemini is also easily scalable across LAN, WAN and the Web to meet any future growth requirements. 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. The system may be used with a variety of databases including Oracle and Microsoft SQL Server. 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 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. Our LIMS becomes your LIMS very quickly and easily! 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. Example Matrix Workflow Screen 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. 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 MGV1 Page 3 of 11

4 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. Key Functional Steps within Matrix Gemini 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. 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. A translation facility (part of the configuration tools) is included in the system as standard. This allows suitable terminology to be used for each 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. Samples may be registered in Matrix Gemini in a number of ways: 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. d) template sample registration allows the regular registration of a set of samples, identical or different, at manually selected times. MGV1 Page 4 of 11

5 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 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. 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. 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 prebooked 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. 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. 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. MGV1 Page 5 of 11

6 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. 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. 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. 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. 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:- e) colour coded responses and/or warning messages when results fall outside defined limits f) comprehensive calculation support g) rules for number of decimal places, significant figures, rounding, truncation, scientific notation and more can be set individually for each cell. 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) 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). 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 c) audit trailing is done at the cell or component level d) limits may be applied to any cells (see later) Multiple Sample Result Entry (MSRE) Screen Result limits may be simultaneously assigned and checked at the following levels:- 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. Test by Test Result Entry Screen Multiple limits may be assigned at each level with differing responses e.g. reject, failed, warning, according to the value of the entered result. MGV1 Page 6 of 11

7 Sample Approval Screen Matrix Gemini allows the use of rule based limits which 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. Result import from instruments and systems is available. Devices to be interfaced can vary from simple balances to comprehensive multi-channel chromatography data systems. Matrix Gemini provides result validation and multi- level sample approval stages that may be configured to suit the needs of a particular laboratory/organisation. Reporting Flexibility in Matrix Gemini also extends to the 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. The Explorer search function allows the entry of the known 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. MATRIX LIMS LIMS Reference Tables Standard reference tables in Matrix Gemini include submitter/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. The test table, for example, will contain the definition 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. Full version control is available for each of the tables 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 Split-Screen Displays are much easier to use than 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. Easier to Use Split-Screen Displays Matrix Gemini enhances Productivity in every industry and every laboratory The flexibility and scalability of Matrix make it an excellent choice for many types of laboratory. Today there are users in many countries in the following industries: Analytical Services Biotechnology Chemicals / Polymer Contract Analysis Food & Beverage Material Testing MGV1 Page 7 of 11

8 Medical Devices Metals / Mining Nuclear Petrochemical Pharmaceutical Manufacturing Pharmaceutical R&D Utilities Water / Waste Water For certain specific types of laboratory we have 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. Request separate information on: Stability Express TK for shelf-life testing of Pharmaceuticals & Food Neptune for Water / Waste Water laboratories 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 supports test groups enabling one or more tests to be associated with a test group. The concept of test groups can be used to manage processes and process steps e.g. sample preparation. 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. Rutherford for Nuclear and Radiochemical laboratories SampleTracker for Sample Tracking Feedback for the tracking & resolution of Customer Complaints, Compliments and Comments The extensive core functionality of Matrix can be further extended by adding one or more of several options to your Matrix license: Active Training Manager: actively assists in 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. Event Scheduler may be used to schedule certain types of event to happen at a given time / date eg: Schedule several management reports to run on the last Friday of the month. Run a sample backlog report at 1.00 AM each day. Register a panel of routine samples on the second and third Monday of the month. Frequency Testing: is used to vary the tests associated 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 Steps Example The status of the entire process and each individual step can be monitored using an overview 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. Process Status Instrument Calibration & Maintenance: is used to monitor and record calibration and maintenance MGV1 Page 8 of 11

9 Statistical Process Control charts (SPC) Charts Matrix Gemini also permits screens to be configured to display Statistical Process Control charts (SPC) using our unique OneTime Configuration tools. The following chart types are available: Distribution: the frequency distribution of the same data. This data is non-normally distributed because it is random - the blue line shows the expected random distribution given the data's mean and variance. Integrating Your Lab with your other Business Systems Trendline: a set of randomly generated data shown as a trendline in date sequence X-Chart: the X-Chart (chart of the means) for the data. An error condition exists, which the software automatically circles in red. In today s fast paced world it is vital to be able to link the laboratory to your other Enterprise 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 achieve this integration. Web services and XML provide a 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 offers a fully functional API that consists of a complete suite of Active X objects 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 called Generic Selector screens that can display information resident in another system on a Matrix screen via an SQL query and ODBC. Matrix integrates seamlessly with your other business systems in a simple and supportable way. Comprehensive Regulatory Compliance R-Chart: the R-Chart (chart of the ranges) for the data. An error condition exists, which the software automatically circles in red. Three points lie outside of on standard deviation from the mean which the software automatically marks with yellow chart markers. Matrix Gemini is designed for use in both highly regulated and unregulated laboratories. Whether you must comply with cglps and cgmps and FDA 21 CFR Part 11 in pharmaceutical companies, NELAC and ISO in water testing laboratories or food testing or NAMAS / UKAS regulations, Matrix has the tools and design to help you comply. MGV1 Page 9 of 11

10 Matrix products are developed and produced in an ISO 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: User Requirements Functional Specifications Design Specifications Source Code Test Scripts Validation Services We welcome Customer audits Test scripts are available for purchase that can be used to execute IQ and OQ. For Matrix Stability Express, full IQ and OQ services are available. We work closely with several experts in validation of laboratory systems and will be happy to consult with you on your exact needs Remember - If it is not documented then it does not exist! Business Partners Autoscribe Ltd. the developers of Matrix products are 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: Crystal Reports from Business Objects for all reporting needs LimsLink from Labtronics to connect instruments to Matrix Gemini LIMS JMP from SAS Institute for shelf life projections and general statistical calculations and graphs relating to stability studies Of course we use both Oracle and Microsoft SQL Server as our host database. Proven Implementation at a Fixed Price We have an outstanding reputation for delivering high 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. As each lab is somewhat different, each implementation 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. Request details of our LIMS Implementation Methodology Post Implementation Support Completion of the implementation phase of a project 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 ed back to our support center for us to help you fix a problem or effect a change. When you call our support line you normally speak directly with someone technical who can assist you directly - no being given a number and the promise of a call back! Other support activities include: Monthly newsletter Annual User Group Meeting Scheduled training classes On-line web tutorials and trouble shooting Security and Audit Trails All Matrix Gemini users have a password controlled authority 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. Matrix Gemini has been successfully validated to operate 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) All activities relating to samples, tests, resources, projects, 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. MGV1 Page 10 of 11

11 For Further Information Contact: AUTOSCRIBE LIMITED Wellington House Riseley Business Park Basingstoke Road Riseley, Berkshire RG7 1NW, United Kingdom Tel: + 44 (0) Fax: + 44 (0) matrix@autoscribe.co.uk Website: MGV1 Page 11 of 11