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Prepared by                                                 Guided by
Shivam Thakore                                              Mr Chintan Oza
                 Department of Pharmaceutical Technology,
4/10/2013          LJ Institute of Pharmacy, Ahmedabad                       1
Information Technology
     What is information Technology??
     Information technology is the application of
      computers and telecommunications equipment to
      store, retrieve, transmit and manipulate data, often
      in the context of a business or other enterprise.
     The automation of all the manual work of the
      Pharmaceutical industry is based on the principles of
      IT systems.
     There are many different automated softwares that
      aid the smooth functioning of pharmaceutical units
      and improve efficiency, accuracy and decision making


                      Department of Pharmaceutical Technology,
4/10/2013               LJ Institute of Pharmacy, Ahmedabad      2
Pharmacy Informatics
     Application of IT systems in Pharmaceutical
      industry     is   called   as      PHARMACY
      INFORMATICS
     The scientific field that deals with biomedical
      information, data, and knowledge – their
      storage, retrieval, and optimal use for problem-
      solving and decision-making.
     It is tightly focused on the optimal use of drug
      information for problem-solving, decision-
      making, and promoting safe pharmaceutical
      care.

                      Department of Pharmaceutical Technology,
4/10/2013               LJ Institute of Pharmacy, Ahmedabad      3
Why do PHARMACIST
needed in INFORMATICS
     Crossing the Quality Chasm
     Preventing Medication Errors
     Interconnect clinicians
     Personalize care
     Improve population health




                     Department of Pharmaceutical Technology,
4/10/2013              LJ Institute of Pharmacy, Ahmedabad      4
Importance in Pharma
Industry
     Decreased manual work
     Smooth & ease of work flow
     Strict security
     Reduced paper work i.e. e-documentation
     Time efficient




                      Department of Pharmaceutical Technology,
4/10/2013               LJ Institute of Pharmacy, Ahmedabad      5
Automated systems in Industry
Various IT Systems in Pharmaceutical Industry
Computerized physician order entry (CPOE)
Enterprise Resource Planning (ERP)
Laboratory Information Management System (LIMS)
Sales Force Automation (SFA)
eBR (Electronic Batch Records)
Customer Relationship Management (CRM)
Clinical trial Management system (CTMS)
Corrective Action & Preventive Action (CAPA)
Distributed Control System (DCS)
Computerized Maintenance Management System
(CMMS)
                   Department of Pharmaceutical Technology,
4/10/2013            LJ Institute of Pharmacy, Ahmedabad      6
Computerized Physician
Order Entry (CPOE)
     CPOE is defined to include both inpatient orders
      and the electronic ordering of outpatient
      prescriptions often referred to as e-prescribing..
     It allows physicians & other caregivers input
      orders directly into a computer, thereby
      eliminating     problems     with     handwriting
      legibility and order transcription.
     Physician can make good clinical decisions
      based on e-records of patients.




                       Department of Pharmaceutical Technology,
4/10/2013                LJ Institute of Pharmacy, Ahmedabad      7
CPOE, It helps in
 Order entry into the pharmacy information
  system,
 Online order verification by pharmacist
 Computerized warnings for drug allergies,
 Inappropriate doses.
 Drug-drug interactions.
 Computer-supported medication supply and
  distribution.
 Automated label generation,
 Computerized pharmacy billing.


                Department of Pharmaceutical Technology,
4/10/2013         LJ Institute of Pharmacy, Ahmedabad      8
Computerized Physician
Order Entry (CPOE)




            Department of Pharmaceutical Technology,
4/10/2013     LJ Institute of Pharmacy, Ahmedabad      9
Enterprise Resource Planning
(ERP)
     An ERP system integrates all data and processes of
      an organization. Such integrated systems reduce
      information silos in various departments.
     The purpose of ERP is to facilitate the flow of
      information between all business functions inside the
      boundaries of the organization and manage the
      connections to outside stakeholders




                      Department of Pharmaceutical Technology,
4/10/2013               LJ Institute of Pharmacy, Ahmedabad      10
     ERP consists of various modules
       production and inventory management
       weighing and dispensing
       E-batch records
       E-packaging records
       Financial accounting
       Personnel management
       Training and development




                     Department of Pharmaceutical Technology,
4/10/2013              LJ Institute of Pharmacy, Ahmedabad      11
Laboratory Information
Management System (LIMS)
     It manages the information flow within the lab
      and can be the modus operandi of connecting the
      lab with the rest of the organization.
     Automates       lab    processes    to    increase
      productivity, efficiency and quality in analysis.
     More important is that, it takes care of 70% of
      laboratory guidelines, what we called as GLP.




                       Department of Pharmaceutical Technology,
4/10/2013                LJ Institute of Pharmacy, Ahmedabad      12
     LIMS enables laboratories handle complex work flow
      and sample data management requirements.
     It helps from
       Sample request to sample registration,
       Sample collection
       Automatic calculations of tests methods
       Specification maintenance
       Assigning properties to those tests
       recording results, generating reports
       Issuing COA’s




                     Department of Pharmaceutical Technology,
4/10/2013              LJ Institute of Pharmacy, Ahmedabad      13
Sales Force Automation (SFA)
     SFA are information systems used in CRM
      marketing and management that helps to
      automate some sales and sales management
      functions.
     It is a system that automatically records all the
      stages in a sales process.
     It manages data, controls on-line the movement
      of goods and manpower, including distribution
      network for pharmaceutical marketing




                       Department of Pharmaceutical Technology,
4/10/2013                LJ Institute of Pharmacy, Ahmedabad      14
     It automates all the areas starting from
       On-line records
       Doctor visit reports
       Tour plans and approvals,
       Sales summaries & Booking sales orders
       Expense details & stockist inventory




                     Department of Pharmaceutical Technology,
4/10/2013              LJ Institute of Pharmacy, Ahmedabad      15
eBR (Electronic Batch
Records)
     It is a software for on-line management of batch
      manufacturing and packaging records.
     It converts the bulky documentation work into
      very centralized automatic version.
     EBR aggregates data from across various silos
      of stored information and contextualizes it into
      one consolidated record for the lot produced.




                      Department of Pharmaceutical Technology,
4/10/2013               LJ Institute of Pharmacy, Ahmedabad      16
     It perfoms following functions
       Secured document management
       checks data integrity
       performs automatic calculations
       Automatic audit trail
       other control measures to help ensure compliance
         with 21 CFR Part 11 regulation
      (ELECTRONIC           RECORDS;      ELECTRONIC
         SIGNATURES)




                     Department of Pharmaceutical Technology,
4/10/2013              LJ Institute of Pharmacy, Ahmedabad      17
To sum up…
 High competition, less time to reach the market and a
  highly regulated environment have forced Indian pharma
  companies to adopt advanced and latest IT and
  automation solutions.
 In the recent years, there has been a significant rise in the
  use of computer related systems in the pharma industry.
 Many industries have got most of their operations
  computerized. Not just the big pharma companies, but
  even about 70% of the small and medium enterprises
  utilize automation in one form or the other. Software
  systems are being increasingly accepted as an essential
  part of a modern and progressive pharma industry.



                     Department of Pharmaceutical Technology,
4/10/2013              LJ Institute of Pharmacy, Ahmedabad        18
Department of Pharmaceutical Technology,
4/10/2013     LJ Institute of Pharmacy, Ahmedabad      19

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Role of Information Technology in Pharmaceutical industry

  • 1. Prepared by Guided by Shivam Thakore Mr Chintan Oza Department of Pharmaceutical Technology, 4/10/2013 LJ Institute of Pharmacy, Ahmedabad 1
  • 2. Information Technology  What is information Technology??  Information technology is the application of computers and telecommunications equipment to store, retrieve, transmit and manipulate data, often in the context of a business or other enterprise.  The automation of all the manual work of the Pharmaceutical industry is based on the principles of IT systems.  There are many different automated softwares that aid the smooth functioning of pharmaceutical units and improve efficiency, accuracy and decision making Department of Pharmaceutical Technology, 4/10/2013 LJ Institute of Pharmacy, Ahmedabad 2
  • 3. Pharmacy Informatics  Application of IT systems in Pharmaceutical industry is called as PHARMACY INFORMATICS  The scientific field that deals with biomedical information, data, and knowledge – their storage, retrieval, and optimal use for problem- solving and decision-making.  It is tightly focused on the optimal use of drug information for problem-solving, decision- making, and promoting safe pharmaceutical care. Department of Pharmaceutical Technology, 4/10/2013 LJ Institute of Pharmacy, Ahmedabad 3
  • 4. Why do PHARMACIST needed in INFORMATICS  Crossing the Quality Chasm  Preventing Medication Errors  Interconnect clinicians  Personalize care  Improve population health Department of Pharmaceutical Technology, 4/10/2013 LJ Institute of Pharmacy, Ahmedabad 4
  • 5. Importance in Pharma Industry  Decreased manual work  Smooth & ease of work flow  Strict security  Reduced paper work i.e. e-documentation  Time efficient Department of Pharmaceutical Technology, 4/10/2013 LJ Institute of Pharmacy, Ahmedabad 5
  • 6. Automated systems in Industry Various IT Systems in Pharmaceutical Industry Computerized physician order entry (CPOE) Enterprise Resource Planning (ERP) Laboratory Information Management System (LIMS) Sales Force Automation (SFA) eBR (Electronic Batch Records) Customer Relationship Management (CRM) Clinical trial Management system (CTMS) Corrective Action & Preventive Action (CAPA) Distributed Control System (DCS) Computerized Maintenance Management System (CMMS) Department of Pharmaceutical Technology, 4/10/2013 LJ Institute of Pharmacy, Ahmedabad 6
  • 7. Computerized Physician Order Entry (CPOE)  CPOE is defined to include both inpatient orders and the electronic ordering of outpatient prescriptions often referred to as e-prescribing..  It allows physicians & other caregivers input orders directly into a computer, thereby eliminating problems with handwriting legibility and order transcription.  Physician can make good clinical decisions based on e-records of patients. Department of Pharmaceutical Technology, 4/10/2013 LJ Institute of Pharmacy, Ahmedabad 7
  • 8. CPOE, It helps in  Order entry into the pharmacy information system,  Online order verification by pharmacist  Computerized warnings for drug allergies,  Inappropriate doses.  Drug-drug interactions.  Computer-supported medication supply and distribution.  Automated label generation,  Computerized pharmacy billing. Department of Pharmaceutical Technology, 4/10/2013 LJ Institute of Pharmacy, Ahmedabad 8
  • 9. Computerized Physician Order Entry (CPOE) Department of Pharmaceutical Technology, 4/10/2013 LJ Institute of Pharmacy, Ahmedabad 9
  • 10. Enterprise Resource Planning (ERP)  An ERP system integrates all data and processes of an organization. Such integrated systems reduce information silos in various departments.  The purpose of ERP is to facilitate the flow of information between all business functions inside the boundaries of the organization and manage the connections to outside stakeholders Department of Pharmaceutical Technology, 4/10/2013 LJ Institute of Pharmacy, Ahmedabad 10
  • 11. ERP consists of various modules  production and inventory management  weighing and dispensing  E-batch records  E-packaging records  Financial accounting  Personnel management  Training and development Department of Pharmaceutical Technology, 4/10/2013 LJ Institute of Pharmacy, Ahmedabad 11
  • 12. Laboratory Information Management System (LIMS)  It manages the information flow within the lab and can be the modus operandi of connecting the lab with the rest of the organization.  Automates lab processes to increase productivity, efficiency and quality in analysis.  More important is that, it takes care of 70% of laboratory guidelines, what we called as GLP. Department of Pharmaceutical Technology, 4/10/2013 LJ Institute of Pharmacy, Ahmedabad 12
  • 13. LIMS enables laboratories handle complex work flow and sample data management requirements.  It helps from  Sample request to sample registration,  Sample collection  Automatic calculations of tests methods  Specification maintenance  Assigning properties to those tests  recording results, generating reports  Issuing COA’s Department of Pharmaceutical Technology, 4/10/2013 LJ Institute of Pharmacy, Ahmedabad 13
  • 14. Sales Force Automation (SFA)  SFA are information systems used in CRM marketing and management that helps to automate some sales and sales management functions.  It is a system that automatically records all the stages in a sales process.  It manages data, controls on-line the movement of goods and manpower, including distribution network for pharmaceutical marketing Department of Pharmaceutical Technology, 4/10/2013 LJ Institute of Pharmacy, Ahmedabad 14
  • 15. It automates all the areas starting from  On-line records  Doctor visit reports  Tour plans and approvals,  Sales summaries & Booking sales orders  Expense details & stockist inventory Department of Pharmaceutical Technology, 4/10/2013 LJ Institute of Pharmacy, Ahmedabad 15
  • 16. eBR (Electronic Batch Records)  It is a software for on-line management of batch manufacturing and packaging records.  It converts the bulky documentation work into very centralized automatic version.  EBR aggregates data from across various silos of stored information and contextualizes it into one consolidated record for the lot produced. Department of Pharmaceutical Technology, 4/10/2013 LJ Institute of Pharmacy, Ahmedabad 16
  • 17. It perfoms following functions  Secured document management  checks data integrity  performs automatic calculations  Automatic audit trail  other control measures to help ensure compliance with 21 CFR Part 11 regulation (ELECTRONIC RECORDS; ELECTRONIC SIGNATURES) Department of Pharmaceutical Technology, 4/10/2013 LJ Institute of Pharmacy, Ahmedabad 17
  • 18. To sum up…  High competition, less time to reach the market and a highly regulated environment have forced Indian pharma companies to adopt advanced and latest IT and automation solutions.  In the recent years, there has been a significant rise in the use of computer related systems in the pharma industry.  Many industries have got most of their operations computerized. Not just the big pharma companies, but even about 70% of the small and medium enterprises utilize automation in one form or the other. Software systems are being increasingly accepted as an essential part of a modern and progressive pharma industry. Department of Pharmaceutical Technology, 4/10/2013 LJ Institute of Pharmacy, Ahmedabad 18
  • 19. Department of Pharmaceutical Technology, 4/10/2013 LJ Institute of Pharmacy, Ahmedabad 19