computer system validation,SAP & ERP systems

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COMPUTER SYSTEM VALIDATION, SAP & ERP SYSTEMS:

COMPUTER SYSTEM VALIDATION, SAP & ERP SYSTEMS PREPARED BY : VISHAL RUPAPARA M.PHARM SEM II ROLL NO. : 02 GUIDED BY: Dr. SANDEEP NATHWANI 1

CONTENTS:

CONTENTS Computer system validation (CSV) what and why ?? which system should be validated?? What is USFDA 21 CFR Part 11 ?? objectives CSV life cycle ERP System what is ERP? Early history advantages and disadvantages 2

CONT…:

CONT… SAP System what is sap? sap today sap in pharmaceutical industry Questions References 3

WHAT IS COMPUTER SYSTEM VALIDATION:

WHAT IS COMPUTER SYSTEM VALIDATION It is the process that provides confirmation by examination and provision of objective evidence that computer system specifications conform to user needs and intended uses, and that all requirements can be consistently fulfilled. Computer System Validation (CSV) provides documented proof that the system (e.g. hardware, software, peripherals and network) will repeatedly and reliably do what it is designed to do, is "fit-for-purpose", and complies with the applicable rules and regulations. 4

WHY TO VALIDATE :

WHY TO VALIDATE To ensure that good business practices are followed To satisfy regulatory agency requirements To increase acceptance of the systems by end-users To avoid high maintenance costs 5

WHICH SYSTEMS SHOULD BE VALIDATED ???:

WHICH SYSTEMS SHOULD BE VALIDATED ??? Computer systems performing regulated operations shall be validated. Typical examples of such systems are: Systems that control the quality of product during its development, manufacturing, testing, and handling processes Systems that create, modify, maintain, archive, retrieve, or transmit data used to prove the safety, efficacy, and quality of product and formulations 6

CONT…:

CONT … Systems that provide information on which decisions are made affecting of the product quality Systems that create, modify, maintain, archive, retrieve, or transmit records that must be available for inspection by a regulatory agency Systems that provide data or reports that are sent to regulatory agencies 7

What is USFDA 21 CFR Part 11 ? :

What is USFDA 21 CFR Part 11 ? 8 A set of rules formulated by USFDA governing access, storage, retrieval, control and security of Electronic records A set of rules governing security, control and use of electronic signatures The basis by which Electronic records and signatures may be used as equivalents to paper records and traditional handwritten signatures Examples of E-records Batch Records ( Manufacturing records) Compliance Records ( Validation IQ / OQ / PQ Protocols) Laboratory data ( Routine inspection, Stability sample management) Manufacturing data (Master formulation record, Master Packaging record) Training records ( cGMP 21 CFR Part 210, 211 and Part 11) Calibration tracking records ( Laboratory equipments ) Audit trails ( Deviations listing, Resource logs)

OBJECTIVE:

OBJECTIVE To discuss validation of computerized systems including: System specifications Functional specifications Security Back-ups Validation: Hardware Software 9

System specification (Control document) :

System specification (Control document) In place, stating: objectives of a proposed computer system the data to be entered and stored how it interacts with other systems and procedures the information to be produced the limits of any variable 10

Functional specification (Performance specification) :

Functional specification (Performance specification) Provide instructions for: testing, operating, and maintaining the system names of the person(s) (development and operation) Various considerations: location power supply temperature magnetic disturbances 11

CONT…:

CONT … GMP requirements for computer systems: Verification and revalidation After a suitable period of running a new system Independently reviewed and compared with the system specification and functional specification Change control Alterations made in accordance with a defined procedure Provision for checking, approving and implementing the change Checks Data checked periodically Confirm accurate and reliable transfer 12

Security :

Security Production as well as in quality control Data entered or amended - authorized persons Password system Security systems to prevent unauthorized entry or manipulation of data SOPs for entering data, changing or amending incorrect entries and creating back-ups 13

Back-ups :

Back-ups Procedure describing steps to be taken for the continued recording and control of the raw data in the event of a computer system interruption or failure. Regular back-ups of all files and data Secure storage (prevent intentional or accidental damage) 14

Validation of hardware :

Validation of hardware Appropriate tests and challenges to the hardware No influence of static, dust, power-feed voltage fluctuations and electromagnetic interference. It should prove: Appropriate capacity Operational limits e.g. memory, connector ports, input ports Performance under worst-case conditions e.g. long hours, temperature extremes Reproducibility/consistency e.g. by performing at least three runs under different conditions 15

CONT…:

CONT … Written qualification protocols; results in qualification reports kept Revalidation – in case of significant changes Validation may be performed by the vendor – but ultimate responsibility remains with the company If records kept by supplier, manufacturer still has to have sufficient records to allow assessment of the adequacy of the validation 16

Validation of Software :

Validation of Software Software: the term used to describe the complete set of programmes used by a computer, and which should be listed in a menu. Focus should be placed on: accuracy, security, access, retention of records, review, documentation and accuracy of reproduction 17

CONT… :

CONT … Points to be considered may include: Consistency in performance : Within pre-established limits) Function : Matching the assigned operational function (e.g. generate batch documentation, different batches of material used in a batch listed) Worst case : Validation under different conditions (e.g. speed, data volume, frequency) Repeats : Sufficient number of times (e.g. replicate data entries) Documentation : Protocols and reports Revalidation : In case of significant changes made 18

CSV LIFE CYCLE :

CSV LIFE CYCLE 19

WHAT IS ERP SYSTEM???:

WHAT IS ERP SYSTEM??? Enterprise Resource Planning A business management system that comprises integrated sets of comprehensive software , which can be used, when successfully implemented, to manage and integrate all the business functions within an organization. It facilitates the flow of information among the different functions within an enterprise. It is a “do it all” system that performs everything from entry of sales orders to customer service. 20

Slide 21:

21 Central database

EARLY HISTORY OF BUSINESS COMPUTING:

EARLY HISTORY OF BUSINESS COMPUTING 1960s - Focus on inventory management and control in production environments 1970s – MRP (Materials Requirement Planning ) software debuts to assist in production scheduling and inventory management -Focuses on resources needed to accomplish scheduled production and when they are needed 1980s – MRP II (Manufacturing Requirement Planning) expands focus of previous systems into management of entire production process incorporating non-production data such as from marketing and finance 22

CONT…:

CONT … 1990s - ERP (Enterprise Resource Planning ) systems apply same data collection and handling mechanisms organization-wide - Expansion of MRP II concepts to all business functions ERP Software Market Revenues, 1993 - 1999 23

ADVANTAGES:

ADVANTAGES facilitates information sharing across organizational units and geographical locations Improved work process Increase access to available data for decision making Timely and accurate information Quick response to changing business operations and market conditions, resulting in improved competition advantages Reduced paper use 24

DISADVANTAGES:

DISADVANTAGES Cost - very costly - beneficial for large companies only Long implementation process ( 2 – 5 years ) Missing functionality for handling earned value, percentage complete and cost forecasts in determining project progress No integration between an ERP system and non-ERP systems Security issues 25

CONT…:

CONT … The accounting rules and report terminologies – difficult to understand No user friendliness for occasional user Inability to cut and paste No capability for online help 26

WORLD'S TOP 10 ERP VENDORS:

WORLD'S TOP 10 ERP VENDORS SAP Oracle J.D.Edwards one world Peoplesoft Baan Lilly Great Plains IFS EMIS Lawson Sales of Major ERP Vendors 27

WHAT IS SAP ???:

WHAT IS SAP ??? SAP stands for Systems, Applications and Products Pioneer of ERP software market In 1972, five former IBM employees Dietmar Hopp , Hans-Werner Hector, Hasso Plattner , Klaus Tschira , and Claus Wellenreuther -- launch a company called ‘SAP Systems Analysis and Program Development’ in Mannheim, Germany. Their vision : to develop standard application software for real-time business processing. 28

Slide 29:

29

SAP TODAY:

SAP TODAY World’s Largest Business Software Company World’s Third-largest Independent Software Provider Annual revenues exceeding $10 billion Company Statistics 51,400 employees in more then 50 countries 1,500 Business Partners 75,000 customers in more then 120 countries 12 million users 1,00,600 installations 30

SAP Software Timeline:

SAP Software Timeline 1973 - "System R" (real-time data processing) released to market. (Later came to be called "R/1") 1978 - intensive examination of SAP's IBM database and dialog control system leads to the birth of SAP R/2. 1993 - SAP R/3 - 3 tiered architecture - Database, application, user interface - Improved user interface SAP R/3 was officially launched on 6 July 1992. It was renamed  SAP ERP  and later again renamed ECC (ERP Central Component) 31

SAP R/3:

SAP R/3 a business software package designed to integrate all areas of a business 3-tiered Client-server architecture 32

SAP IN PHARMA:

SAP IN PHARMA Pharmaceutical product research, development, manufacturing and distribution require considerable investment in both time and money, and computerization has become key to improving operational efficiency. The implementation of SAP supports the fundamental requirement of minimizing risk to product identity, purity, strength, and efficacy by providing consistent and secure operation and reducing the potential of human error. 33

WHERE ??:

WHERE ?? a. Data and information management systems 1. Material Inventory System 2. Formulation Information System 3. Clinical Supplies Inventory System 4. Clinical Supplies Labelling 5. Stability Information Systems 6. Analytical Information Systems 7. Quality Assurance Information System 8. Project Management Systems b. Problem solving applications 1. Spreadsheet Software (to solve mathematical problems) 2. Expiry Date Prediction 3. Pharmacokinetics (Physiology based Pharmacokinetic Model) 34

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Custom Reports

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36

Success story – MedPointe Inc. :

Success story – MedPointe Inc. A provider of specialty respiratory, cough/cold, pediatric and central nervous system products and maintains a manufacturing facility in Decatur, USA Pharmavision has been implemented to the company's core business process and key manufacturing areas. Med Pointe's financials, order management, procurement, inventory management, batch management, process manufacturing, quality management, distribution, custom interfaces and charge back processes effectively employed the solution in only six months 37

SAP ERP end users :

SAP ERP end users INTAS CLARIS SPAN TORRENT ALEMBIC GLOBAL MSN NATCO MATRIX Dr. REDDY’S APEX MANKIND GLENMARK PFIZER MEDLEY J&J ZYG UNICHEM ASTRAZENECA NATURAL CADILA EMCUR WATSON RANBAXY RUSAN 38

QUESTIONS:

QUESTIONS What are ERP systems? Explain the advantages of implementation of ERP systems. (June/July- 2011)   Describe the salient features of SAP with reference to pharmaceutical industry. (June/July- 2011) Write a note on computer system validation. (June/July- 2011) Why the computer system needs to be validated? How entrepreneur resource planning make use of computers? (July 2010) 39

REFERENCES:

REFERENCES Orlando Lopez, 21 CFR part 11 : complete guide to International computer validation compliance for the pharmaceutical industry, Sue Horwood publishing, pg no. 5 -11 James Swarbrick , Encyclopedia pf pharmaceutical Technology, Third edition, pg no. 707-713 Haim Mendelson , ERP overview, Graduate School of Business, Stanford University, Stanford. Pg no 1-18 40

CONT…:

CONT … Christopher M. Riley, Thomas W. Rosanske , Development and Validation of Analytical Methods, volume 3, Elsevier science Ltd. Chandra Shekar CV, Seminar SAP Life sciences, Soltius Singapore Pte Ltd. n.v . Leuven , b.v . Gorinchem , Paper on Computer System Validation practice (CSV), ps_testware . mySAP.com www.stsv.com www.emeraldinsight.com www.sap.com 41

Slide 42:

42 THANK YOU…

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