Laboratory Information Management System

StatisticalProcess Control

Lab Inventory

Calibration

LIMS

Stability

DispensingERP Interface

Complaint Tracking

Process MonitoringInstrumentInterfacing

Reagents Management

Spectrum LIMS, a web-based solution thatfits your needs, gives you control andhelps you excel.

Spectrum LIMS (Laboratory Information ManagementSystem) is an FDA 21 CFR part11 compliant softwaresolution which caters for a laboratory’s analytical andresource management needs, whilst monitoringcompliance requirements.

Healthcare and environmental labs are usually pressedfor time and resources. The key function of these labsinvolves testing a large number of samples, whichgenerates an enormous amount of data. This extensivedata gathering and tabulation process requiresmeticulous care. The multiple steps, complexprocedures and calculations contain significant risksof manual errors or oversight. Spectrum LIMS makessuch complex tasks simple to execute, organize,understand and manage.

Spectrum maintains data quality and integrity by takingaway the onerous work load of data gathering,mathematical calculations and statistical operationson day-to-day activities.

Spectrum has been developed to manage laboratoryinformation and quality operations functions in anautomated and controlled manner. Spectrum LIMS isfocused on optimizing laboratory performance, andtime and resource management. Optimization helpsincrease the laboratory's throughput, saves cost, andenhances customer satisfaction.

ROI Case StudyA leading international pharmaceutical companyimplemented Spectrum at one of their plants.Previously they were using a renowned ERP system’squality module to manage analytical and reportingneeds at their manufacturing facility, but found thatthe legacy system did not provide in-depth analysisand the data gathering required significant manualeffort.

In particular, the preparation of the annual productreview (requiring a complete set of batch data withhistorical and trend analysis) was onerous and difficultto manage.

Following the implementation of Spectrum, the timeand effort included in preparing the annual productreview data was reduced to a few clicks, saving thecompany significant cost from this process alone.

A unique solution withintegrated StatisticalProcess Control.

Benefits

Cost Saving

Continuous Improvement

Compliance Reporting

Resource Optimization

Knowledge Management

Information Sharing

Efficient Time Management

Minimize Errors

Increase Throughput

Spectrum’s software architecture provides completeflexibility to configure the application according to yourorganization’s specific needs.

Spectrum is a completely user-configured application that is easy to implement.Defining your quality domain is a simple activity, yet it comprehensively depictsa true picture of your processes. Steps of the processes are logically sequencedand provide complete information on each process event or activity. Fromquality of raw materials to the completion of the finished product, Spectrummonitors the end-to-end process.

LabInventory

ReagentsManagement

ProcessMonitoring& Control

ERPExternal

ReportingSolution

Dashboard

ComplianceReporting

StatisticalProcessConrol

Decision Support& Operational

Reporting

Analytical Testing&

CalculationsWork List

AssignmentSampleLogin

ManualInput

ERP

Dispensing Calibration InstrumentInterfacing

ComplaintTracking Stability

C O M P L I A N C E

LIMS Module

Master DataManagement User Security Audit

and Control

Foundation Component (Supporting All Modules) KeyCore

Module

Activity

The solution is scalable acrossmultiple plants and geographicallocations. Scalability of thesolution provides the opportunityto use Spectrum in an integratedenvironment or to deploy itsdifferent modules independently.

SPECTRUM MODULES

LIMS

Stability

Calibration

Process

Inventory

Reagents

Complaints

Dispensing

Sofcom’s aim is to make the implementation andsupport of our solutions as simple and easy aspossible for our clients. Spectrum implementationhas zero percent failure rate and we havedeveloped tools to assist our clients for quickdeployment of our solution. Most of our clientsfind that the solution can be configured and readyto use within a few weeks.

Spectrum supports the gathering and sequencing ofsamples for organic, inorganic, chemical, toxic testingor indeed any other analytical test where specificstandards and procedures are followed.

Spectrum can easily process multiple types of samplesand can undertake various different calculations orprocesses on each one. Sample testing can be groupedor performed individually as required. These groupscan be by type of test (e.g. micro-biological, toxic etc.)or by type of products (e.g raw material, semi-finishedgoods etc.)

Spectrum Implementationhas zero percent failure rate.

Spectrum provides thefunctionality to manage awide range of testingactivities.

Spectrum ensures that internal SOPs and performance parametersare deployed correctly.

Comprehensive testing procedures can be configuredwithin Spectrum to control and manage a wide rangeof different types and methods of test. When a newsample is logged into the system, it automaticallyassigns the tests to be performed (as per theconfiguration of the corresponding sample type) withthe relevant parameters, such as the required numberof readings and decimal places. The user can also attachany additional tests required to be performed on eachsample.

Test Specification

Spectrum allow users to easily configure different typesof tests, including non-numeric tests such asappearance and colour, and numeric tests such as pH,assay and dissolution. It also supports complex formulacalculations or any other test needed to comply withyour organization’s Standard Operating Procedures(SOPs).

Test Limits

Each test can carry different types of limits to facilitatetest behaviour monitoring. Spectrum maintains bothcontrol/quality limits and passing limits to achieve TotalQuality Management (TQM). The system prompts theuser when it recognises an A-typical test result.

Results

The results can be transferred through InstrumentInterfacing directly from an instrument or enteredmanually. Entry screens automatically adopt the user-defined procedures for each specific test andautomatically perform simple or complex calculations(as required) to obtain the final result. Detailedinformation from these activities is maintained forreporting, trend analysis and to identify opportunitiesfor optimization.

Repeat Test Results

Spectrum accepts any number of repeat test resultsand records them for further analysis. The user canincrease the number of raw data readings for eachrepeat test as required.

Final Review

On completion of sample or batch testing, the decisionscreen displays all of the relevant information aboutthe batch/sample, from its receipt and initial raw datareadings, to the final results.

Spectrum also supports result based decisions for batchand samples. The system prompts the user when testresults fall beyond the configured passing or controllimits.

Revalidation / Retest

Spectrum provides information to the user for thebatches which are due for revalidation or retest withinspecified time ranges, providing visibility aboutscheduled activities. For the revalidation of batchesand samples, Spectrum follows the configuredrevalidation protocol of each correspondingproduct/material.

Resource Management

Spectrum generates and manage comprehensive worklist for testing work-load and laboratory time andresources to be distributed across different analysts ona test level at the point the sample is received. Thesystem keeps track of each testing activity on samplesreceived to enable managers and technicians to seethe exact status and the work load of each sample.

Performance measurement is a key factorin driving business excellence. This dependson how processes can be measured againsttheir potential and against internal andexternal standards and benchmarks.Spectrum ensures that internal standardsand performance parameters are deployedand adhered to correctly, identifying thepotential to strengthen processes forperformance improvement and resourceoptimization. The system includesintelligence to analyze comparative data,historical data and trends, to drivecontinuous improvement.

SPC is an integral part ofSpectrum which provides anefficient means of acquiringinformation to facilitateprocess understanding, achievecontinuous improvement andto share information andknowledge.

Spectrum provides the right foundation toenable a company to improve quality andachieve Total Quality Management (TQM).

Spectrum has the capabilityto acquire data directly fromlaboratory instruments.

Using the Instrument Interfacing functionality, testingdata from electronic balances, HPLCs, pH meters andmany other instruments can be transferredautomatically to Spectrum, minimizing the chances oferrors, and saving valuable man-hours. When integratedwith the Instrument Calibration module, Spectrumchecks the calibration record of each instrument beforeaccepting the results.

ERP Interface

The system can be easilyintegrated with all major ERPsolutions. Its user-friendlyinterface minimizes extensivetime and resources to deploy theapplication in a real timeenvironment.

Six Sigma monitoringPareto diagramHistogramScatter diagramTrend analysisx - chartX - chartR - chart, p – chart, s - chartCp, Cpk analysis

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The Dashboard facility inSpectrum provides seniormanagement with acomprehensive view of all therelevant operationalperformance at a single glanceto support key decision-makingand to serve as a hub forinformation sharing.

Comprehensive MISSpectrum has a comprehensive ManagementInformation System (MIS), which is the keystone forsuccessful planning and operations. Seniormanagement rely on these programs to evaluate theoverall quality operations performance, whileproduction teams use the system to manage processinformation and facilitate knowledge sharing.

Spectrum provides a widevariety of reports andinquiries, ranging from simplelistings, through analyticalreports to decision-supportreporting.

All reports and inquiries have user-defined selectioncriteria and provide multiple views of the informationfrom a single report or inquiry. Spectrum can generatehistorical reporting to help with trend analysis, samplebehavior, supplier performance, analyst performanceand to support the compilation of annual/periodicproduct reviews

Prompts and alerts areavailable in the system.

SupportSpectrum post-implementation support isprovided by a dedicated team of trainedand experienced professionals. Thestrength of our team is demonstrated byour business domain knowledge and ourfocus on understanding each customer’sneeds.

Our on-going development efforts andupgrade strategy demonstrate ourcommitment to continually improving ourproduct and providing long term return onour customer’s valuable investment.

We find Sofcom goodbusiness partners.....

“LIMS and the Stability modules areeffective laborator y tools for themanagement of analytical and stabilitydata. Our lab has benefited greatly fromthese tools, resulting in significant timesaving, no more manual data entries andallowing the monitoring of cycle time foranalysis per batch / per analyst forproductivity improvement; just a click andwe can get trend sheets for as many yearsas we want! The systems are validated andare compliant with advanced GLPrequirements like Electronic Signatures,Audit Trails, System Security, Historical DataRetention etc... We find Sofcom goodbusiness partners and are working closelywith them to develop more innovatives o l u t i o n s a i m e d a t c o n t i n u o u si m p rove m e n t i n p h a r m a c e u t i c a lmanufacturing”.

Ms. Ruby ShaikhSenior Manager Quality ControlBristol Myers Squibb Pakistan

www.spectrumtqm.com

Sofcom (Private) LimitedSofcom House, ST-9Block 5, Gulshan-e-IqbalKarachi-75300, PakistanPh: +9221 4966991Fax: +9221 4809032contact@sofcom.net

Sofcom USA Inc.2727 Curtiss St.Downers GroveIL 60515Ph: +1 630 353 4300Fax: +1 630 663 4547contactusa@sofcom.net