Presentation on theme: "Deliver More … Deliver Excellence!"— Presentation transcript:
1Deliver More … Deliver Excellence! Pittsburgh, PA. USA
2About CaliberCaliber is a company focused on IT solutions for Laboratories Specially GLP/GAMP compliant.Established in the year 2001Global Marketing HQ at Pittsburgh USAISO CertifiedWell organized Development processAbsolute leadership in Indian Pharma IndustryBest Product Award winner--- from HYSEACIO 100 Asia, best project award winner
3CaliberLIMS® Industry Verticals Pharmaceuticals Manufacturing QCResearch & Drug DevelopmentPetrochemicalsWater & EnvironmentFood TestingPublic healthTraining Management in GMP
13What is in it for Me?? Clear job Description Great reduction in errors, LIMS is Error prevention system !!Quicker completion of the job..- Deliver More!Automatic Adherence to the Quality System like ISO17025- Deliver Excellence!
14Front Desk:No RegistersClick & Select Sample RegistrationAutomatic Costing /BillingSample StatusChemistMy jobs- ListClear worksheetNo CalculationsAll Support Documents available on clickLab HeadOn-line Review of result & raw dataLab Sample StatusWork load CalculationLab inventoryManagementOn-line approvalSample Status of all the labsRisk ManagementVarious report
15Solution … CaliberLIMS Fully web-based, .NET technologyN-tier architecture, modular designEasy integration with ERP (certified SAP integration)Easy to implement, Easy to useRequires minimal customization, out of the boxModel based: Requires minimal training,Meets/exceeds Regulatory requirements of FDA/ MHRAWebservices & XML based engines
17Why Caliber LIMS Technology: On web technology since Year 2001 Good value propositionRobust FrameworkGAMP compliant implementation processShort Learning CurveProven Track record through successful international regulatory audits
18Product Technology - Benefits CaliberLIMS 3.X.X is built on Microsoft .Net Technology -Built on n-tier Technology web Technology.Choice of DB MS SQL or Oracle100 % Browser based client operationsSpecially designed OOPS model for regulated industry.Highly stable and leading Microsoft Architecture.
19Technology Benefits Highly scalable application. Lesser maintenance. Lesser Validation burden.Lower cost of ownership.Easier Upgrades.Shorter Learning curve.Quick ROI.…… Hence it is a preferred product!!
20CaliberLIMS Features End- to - End Lab Management Solution Easy to Master configurable workflowsShorter Learning CurveHighly modular, hence implementation can be staggered, if desired.Comprehensive functionality to address all common lab practices, see it to believe it !Configurable enforcement of GLP/FDA normsReports to address all needs of Lab Management
24Allotment by Test category (TCI) to more than one analyst Sample Allotment :Can assign all tests in a sample to one person (SI, Sample in-charge)Allotment by Test category (TCI) to more than one analystAllotment by Test (TI) to more than one analystSI TCI TIApproval Process: TITCISIMGRmore levels of approvals on Demand:
33Configurable & version controlled COA Easy point and click designVersion controlled and old reports are not affected by the current changesPrint control availableCOA compliant to ER & ES rules.
34CaliberLIMS Framework Technical BenefitsCaliberLIMS FrameworkCaliberLIMS has been repositioned as an Enterprise Quality Management Frame work rather than just a LIMSIt is a one place to manage all laboratory functions sitting right at one desktopApplication integration is an important aspect of LIMS 3.x.x34
35Integration is everything !! Flexible Framework for an integrated approach !!
36Application integration CaliberLIMS can be integrated with applications like:ERP like SAPMESHistoriansInstrument Interface toolsReport Generators
37………Why is it a good decision!! CaliberLIMS- SAP………Why is it a good decision!!
38SAP- LIMS integrationSAP is an enterprise wide solution focused on manufacturing and material management.LIMS is a focused activity on Lab Information Management.Quality system norms demand a high degree of data management in the Lab which is specific.
42Just Not Inventory Modules… ….Much more than that !! Working StandardsGet the material Get it analyzed by 3-4 analysts check RSD if OK approve the materialDistribute the material in to bottles (may be one every month)Use bottle after bottleUsage tight integration. i.e unless the usage is recorded, result confirmation is not possibleMaintain consumption records for all the bottles (stock cards)
43Instrument Management : Asset information like..HistoryCalibration scheduling, CalendarCalibration Certificate generationMaintenance tracking, trend analysis.Problem reportingService logsInternal,external calibration trackingCalibration data storageHyperlinks to Validation or SOP docs
44Volumetric Solutions: Prepare- by using Templates for the variable quantityStandardizeSchedule a re-standardization timeGet alertsRecord UsageUsage throuh tight Integration
45Chemical Reagent Preparation and Inventory Template for Reagent Preparation for a standard volume of reagentPrepare reagent within tolerance limitsRecord the usageGet Stock cards, inventory alerts and validity alerts
46Configured COA: Unique Feature ! Problem: You have tested a material batch with in-house specifications and you want to release the COA with a different specifications with the same test results.Solution: Release differently configured COA without altering the results and AR no under strict regulatory guidelinesAnalyze the batch (Bulk FP)Release withDifferent Spec DescriptionDifferent CustomersDifferent Packing typesMay be Different Language…..Everything Under strict regulatory guidelines and audit trails.
47Compiled COA : Unique Feature !! Problem: You have analyzed a batch earlier with 10 tests, now customer wants one more test to be conducted and a new COA released.Solution: Just conduct the new test and combine the earlier test results and the new one and release COA within regulatory guidelinesDo additional testingAdd additional testing to the existing analysisRelease the COAKeep track of all such releases
48Control Sample Management Keep track of the samples which need to stored.Record: Storage place, Quantity, conditions.Pull the sample through a Request- approval processRe-keep the un-used sampleGet alerts for Sample disposingReports: Stock, withdrawal, distruction
50Stability ProtocolDedicated Module to Manage complete Stability Studies.A stability Protocol can be registered with all the necessary details like:Different Conditions with independent set of tests.No. of Pulls per condition.Associated details of a condition and study.Can be implemented as Stand alone stability Management System
51Stability Protocol Registration A Product/ Material can have multiple storage conditionsEach Storage Condition can have multiple Sample pull frequencies registeredFor Each condition tests to be carried out can be selected.Up on completion of the sample approval, trends can be obtained
52Stability ProtocolStability protocol registration is highly configurable to have various input fields relevant to the study.User configurable to all types of products/Materials like: Finished Products. Raw Material, Packing MaterialDynamic conditions and pulls at the time of Protocol registrationConfigurable Protocol Approval ProcessOnce a protocol is approved, changes can be made as per the present stage of the protocol.All such changes are tracked and maintained in a audit trail.
57Stability Sample Chambers (Optional) Define a chamber with all attributes with Storage positions defined.Stability chamber is assigned to ConditionSample storage along with Quantity storedSample withdrawal with Quantity withdrawnStock inventory reports
59Stability Studies reports Reports on click of the mouse:Sample Analytical Test report (COA) for each sampleVery comprehensive , comparative report for one product, different batches, Selected condition, selected Tests.Trend graphsAnnual calendarReports as per protocolsResult compilation
63Configuration Objects There are in excess of 100 Objects in CaliberLIMS 3.0 and every object has inherent capability / configurability to include activities like:Initiation, Approval and E-sign challenge and generation of Audit Trails.
64Object configuration----You can decide how you want LIMS to be!!
66Application Architecture Developed on MS ASP.netCaliberLIMS 3.XX versions are developed on specially designed OOPS model to suite the regulated industry practices. (GLP)More than 100 objects to make the system highly configurable.Increased configurability of the objects
73Deliver More… deliver excellence !! Caliber Technologies Pvt. Ltd. 401,406, Bhanu Enclave, Model Colony, Hyderabad , INDIA Tel : , URL:Caliber Infosolutions, Inc. 100, Technology Dr. Suite 400 Pittsburgh. PA