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Deliver More … Deliver Excellence! Pittsburgh, PA. USA.

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Presentation on theme: "Deliver More … Deliver Excellence! Pittsburgh, PA. USA."— Presentation transcript:

1 Deliver More … Deliver Excellence! Pittsburgh, PA. USA

2 About Caliber  Caliber is a company focused on IT solutions for Laboratories Specially GLP/GAMP compliant.  Established in the year 2001  Global Marketing HQ at Pittsburgh USA  ISO Certified  Well organized Development process  Absolute leadership in Indian Pharma Industry  Best Product Award winner--- from HYSEA  CIO 100 Asia, best project award winner

3 Caliber LIMS ® Industry Verticals  Pharmaceuticals Manufacturing QC  Research & Drug Development  Petrochemicals  Water & Environment  Food Testing  Public health  Training Management in GMP

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5 Recognition  Product — Hysea & Site approvals  Project Management- CIO Asia Award  Company- Deliotte Asia Award  Team -- Entrepreneur of the year More important than all the above: Repeat orders

6 A Few of Our Valued Customers… Caliber LIMS ®  Wyeth  Mylan India (Matrix)  Fresenius  Dr. Reddy’s Ltd (5)  Aurobindo (3)  Unichem  Medicap - Thailand  Panacea  BPCL (25)  Dabur UK  JBCPL (8 Plants)  Zydus Hospira  Sanofi Aventis  Divis Laboratories Ltd Repeat Orders Speak Volumes!! AjantaAjanta Pharma

7 Pharma Industry ……. The Journey

8 Pharma Industry Journey ! Increased work load 100X analysis Vendor audits Process audits Validations Qualifications Annual reports OOT

9 FDA 483s - Quality and Laboratory Issues

10 Common Lab Errors, Common Root Cause  Transcription Errors-- Major Contributor  Calculation errors -  Lack of Information  Insufficient Training  Improper Review  Lack of Controls

11 FDA 483s – Quality and Laboratory Issues

12 How will LIMS help you!!

13 What 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 ISO Deliver Excellence!

14 Front Desk: No Registers Click & Select Sample Registration Automatic Costing /Billing Sample Status Chemist My jobs- List Clear worksheet No Calculations All Support Documents available on click Lab Head On-line Review of result & raw data Lab Sample Status Work load Calculation Lab inventory Management On-line approval Sample Status of all the labs Risk Management Various report

15 Solution … CaliberLIMS Fully web-based,.NET technology N-tier architecture, modular design Easy integration with ERP (certified SAP integration) Easy to implement, Easy to use Requires minimal customization, out of the box Model based: Requires minimal training, Meets/exceeds Regulatory requirements of FDA/ MHRA Webservices & XML based engines

16 Why CaliberLIMS ?

17 Why Caliber LIMS Technology: On web technology since Year 2001 Good value proposition Robust Framework GAMP compliant implementation process Short Learning Curve Proven Track record through successful international regulatory audits

18 Product 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 Oracle  100 % Browser based client operations  Specially designed OOPS model for regulated industry.  Highly stable and leading Microsoft Architecture.

19 Technology 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!!

20 CaliberLIMS Features  End- to - End Lab Management Solution  Easy to Master configurable workflows  Shorter Learning Curve  Highly 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 norms  Reports to address all needs of Lab Management

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22 4 M Rule  Man Machine Material Method

23 Sample Manager ……..Workflow

24 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 analyst Allotment by Test (TI) to more than one analyst SI  TCI  TI Approval Process: TI  TCI  SI  MGR more levels of approvals on Demand:

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26 Task Center….One click approach

27 Sample Status Dash boards ---- Status at a glance …… Click on the desired segment to see further information.

28 Configurable Home page analytics Dashboards Quick Sample status Quick result entry page Quick COA view page Configurable Task alerts panel

29 Trends of any test.. On click

30 Analyst Performance & Service levels

31 Sample Manager Demo

32 Configurable Print Controlled worksheets.

33 Configurable & version controlled COA Easy point and click design Version controlled and old reports are not affected by the current changes Print control available COA compliant to ER & ES rules.

34 CaliberLIMS Framework  CaliberLIMS has been repositioned as an Enterprise Quality Management Frame work rather than just a LIMS  It is a one place to manage all laboratory functions sitting right at one desktop  Application integration is an important aspect of LIMS 3.x.x Technical Benefits

35 Integration is everything !! Flexible Framework for an integrated approach !!

36 Application integration  CaliberLIMS can be integrated with applications like: ERP like SAP MES Historians Instrument Interface tools Report Generators

37 CaliberLIMS- SAP ………Why is it a good decision!!

38 SAP- LIMS integration SAP 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.

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40 The Standard for Instrument to LIMS Interfacing

41 High Value addition optional Modules 1.Chemicals Management 2.Working Standards 3.Ref. Standards 4.Volumetric Solutions 5.**Analyst Qualification 6.Training Management 7.Column Management 8.**Instrument Calibration Mgmt. 9.**Stability Management 9.Microbiology Culture Management. 10.Media Management 11.Label Printing. 12.Lab DMS. 13.Market Complaints. 14.Change Management. 15.Deviation Management. 16.**Outsourcing/ Reduced testing. 17.Lab Costing Module Functional Benefits

42 Just Not Inventory Modules… ….Much more than that !! Working Standards 1.Get the material  Get it analyzed by 3-4 analysts  check RSD  if OK approve the material 2.Distribute the material in to bottles (may be one every month) 3.Use bottle after bottle 4.Usage tight integration. i.e unless the usage is recorded, result confirmation is not possible 5.Maintain consumption records for all the bottles (stock cards)

43 Instrument Management :  Asset information like..  History  Calibration scheduling, Calendar  Calibration Certificate generation  Maintenance tracking, trend analysis.  Problem reporting  Service logs  Internal,external calibration tracking  Calibration data storage  Hyperlinks to Validation or SOP docs

44 Volumetric Solutions:  Prepare- by using Templates for the variable quantity  Standardize  Schedule a re-standardization time  Get alerts  Record Usage  Usage throuh tight Integration

45 Chemical Reagent Preparation and Inventory  Template for Reagent Preparation for a standard volume of reagent  Prepare reagent within tolerance limits  Record the usage  Get Stock cards, inventory alerts and validity alerts

46 Configured 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 guidelines  Analyze the batch (Bulk FP)  Release with Different Spec Description Different Customers Different Packing types May be Different Language …..Everything Under strict regulatory guidelines and audit trails.

47 Compiled 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 guidelines  Do additional testing  Add additional testing to the existing analysis  Release the COA  Keep track of all such releases

48 Control Sample Management  Keep track of the samples which need to stored.  Record: Storage place, Quantity, conditions.  Pull the sample through a Request- approval process  Re-keep the un-used sample  Get alerts for Sample disposing  Reports: Stock, withdrawal, distruction

49 Stability Studies Management

50 Stability Protocol  Dedicated 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

51 Stability Protocol Registration  A Product/ Material can have multiple storage conditions  Each Storage Condition can have multiple Sample pull frequencies registered  For Each condition tests to be carried out can be selected.  Up on completion of the sample approval, trends can be obtained

52 Stability Protocol  Stability 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 Material  Dynamic conditions and pulls at the time of Protocol registration  Configurable Protocol Approval Process  Once 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.

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54 Configurable, Stability Protocol registration.

55 Other Supporting features  Stability study specific Worksheet generation.  Copy control of the worksheets  Stability specific COA header and footer configuration  Stability specific test trends

56 Automatic Sample Login as per Calendar

57 Stability Sample Chambers (Optional)  Define a chamber with all attributes with Storage positions defined.  Stability chamber is assigned to Condition  Sample storage along with Quantity stored  Sample withdrawal with Quantity withdrawn  Stock inventory reports

58 Sample Storage in the chambers

59 Stability Studies reports  Reports on click of the mouse:  Sample Analytical Test report (COA) for each sample  Very comprehensive, comparative report for one product, different batches, Selected condition, selected Tests.  Trend graphs  Annual calendar  Reports as per protocols  Result compilation

60 Stability Sample pull list for a period

61 Stability Sample Calendar

62 LIMS Configuration

63 Configuration  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.

64 Object configuration ----You can decide how you want LIMS to be!!

65 Architectural details !

66 Application Architecture  Developed on MS ASP.net  CaliberLIMS 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

67 SOA Layer DB (SQL/ ORACLE) Data Access Layer User Interface Layer IE5.5 Business Logic ASP.net Transaction interface Layer Messaging services Mail Response Services Status query services Orion MES Instruments Interface Highly scalable architecture N-tier Web Architecture. Technical Benefits

68 Software Environment Application server: Windows 2003 Front End: User Interface: IE 5.5 Back end: 1. SQL 2000 Above 2. Oracle 9i & above Web server: IIS 6.0

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70 Regulatory Compliance

71 Regulatory/ Quality Standards  21 CFR Part 11 Code for Electronic Signatures and Electronic Records  GLP Good Laboratory Practices  ISO  NABL  GAMP compliant documentation

72 Electronic Signature

73 Deliver 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


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