intro_and_pmx.ppt INTRODUCTION COMPANY OVERVIEW PMX ARCHITECTURE VALIDATION APPROACH IMPLEMENTATION OF 21 CFR PART 11

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1 itro_ad_pmx.ppt Oe-Source Supplier for Eterprise Productio Maagemet Meetig Food ad Drug Admiistratio Rockville Jue 14, 2001 Propack Data GmbH Vicez-Priessitz-Str Karlsruhe Germay Propack Data Corporatio 2000 Regecy Parkway, Suite 375 Cary, NC USA PD - PRESENTATION TEAM Christia Fortuel Presidet Propack Data Corporatio phoe: (919) x312 chf@propack-data.com Herma Schaefer Director Customer Services U.S. Propack Data Corporatio phoe: (919) x313 hes@propack-data.com Dr. Gerhard Werlig Director Quality Maagemet & Validatio Services Propack Data GmbH, Germay phoe: gw@propack-data.com PD_FIRST.ppt 2 Propack Data

2 itro_ad_pmx.ppt AGENDA INTRODUCTION COMPANY OVERVIEW PMX ARCHITECTURE VALIDATION APPROACH IMPLEMENTATION OF 21 CFR PART 11 DISCUSSION PD_FIRST.ppt 3 Propack Data 2001 OBJECTIVE Provide isight ito PMX system fuctioality with special focus o implemetatio of 21 CFR Part 11 Get feedback of Propack Data s iterpretatio of 21 CFR Part 11 PD_FIRST.ppt 4 Propack Data

3 itro_ad_pmx.ppt AGENDA INTRODUCTION COMPANY OVERVIEW PMX ARCHITECTURE VALIDATION APPROACH IMPLEMENTATION OF 21 CFR PART 11 DISCUSSION PD_FIRST.ppt 5 Propack Data 2001 GLOBAL ACTION - LOCAL REACH Propack Data Corporatio America Headquarters Cary, NC, USA Brach Offices i Parsippay, NJ Chicago, IL (plaed) Propack Data S.r.L. Vimercate (MI), Italy Propack Data Ltd. Stasted/ Lodo, UK Propack Data S.A.S. Toulouse, Frace Propack Data GmbH Global Headquarters Karlsruhe, Germay Brach Offices i Bad Säckige, Bad Wurzach, Bergisch Gladbach, Leipzig PD_FIRST.ppt 6 Propack Data

4 itro_ad_pmx.ppt HISTORY & OUTLOOK Products & Markets Expasio ASIA First MES Solutio Compay Foudatio ISO 9001 Certificatio 94 Expasio EUROPE 96 SAP Partership 97 Expasio AMERICAS First CTM Solutio The Complete Solutio 02 PD_FIRST.ppt 7 Propack Data 2001 STRONG FOCUS ON PHARMA Biotechology 3% Fie Chemicals & Cosmetics 5% Pharmaceutical 86% Food & Beverage 6% PD_FIRST.ppt 8 Propack Data

5 itro_ad_pmx.ppt PROPACK DATA - REFERENCES WERNER & MERTZ GMBH MAINZ Nahrugsmittel ALUTAS PD_FIRST.ppt 9 Propack Data 2001 QM CERTIFICATE & CUSTOMER AUDITS Sice 1994 ISO Certificatio CUSTOMER AUDITS - last three years Sice 01/2001 ISO 9001:2000 Certificatio PD_FIRST.ppt 10 Propack Data

6 itro_ad_pmx.ppt AGENDA INTRODUCTION COMPANY OVERVIEW PMX ARCHITECTURE VALIDATION APPROACH IMPLEMENTATION OF 21 CFR PART 11 DISCUSSION PD_FIRST.ppt 11 Propack Data 2001 INTEGRATED SOLUTION ERP Key Performace Metrics Applicatio Coector LIMS DMS EPM LOGISTICS DATA ARCHIVE Applicatio Coector AUTOMATION PD_FIRST.ppt 12 Propack Data

7 itro_ad_pmx.ppt PMX THE COMPLETE SOLUTION Utmost Flexibility Paramout Efficiecy ad Quality Research & Developmet Maagemet Maufacturig Executio System Complete Cotrol ad Overview Total Quality Maagemet Cliical Trial Maagemet Maufacturig Quality Service PD_FIRST.ppt 13 Propack Data 2001 PMX IMPROVES cgmp COMPLIANCE Improve cgmp compliace Material Recociliatio Weigh / Dispese Authorizatio Cotrol Batch Record Audit Trail Cotrols for idetificatio Recipe Maagemet Sequecig of Work Flow Device checks Material Idetificatio Lot Maagemet Archivig Reportig Staff Qualificatio Maiteace DISY EBR EDB EINLOP LIMOS PALETTI PDB PEPS TEDIS PD_FIRST.ppt 14 Propack Data

8 itro_ad_pmx.ppt PMX ARCHITECTURE EDB EINLOP PALETTI DISY LIMOS EBR PMX Applicatio Framework Itegratio Framework - PMX Kerel Oracle Database PD_FIRST.ppt 15 Propack Data 2001 PRODUCTION KNOWLEDGE MANAGEMENT E D B Master data maagemet - work ceters - BOM items - storage - compay ad shift caledars - users Versio-cotrolled master data - Master recipe procedures - bills of material - Master recipes - SOPs - Master recipe operatios Electroic sigatures Editor (Word-compatible) PD_FIRST.ppt 16 Propack Data

9 itro_ad_pmx.ppt ELECTRONIC BATCH RECORDING E B R Iteractive HTML-based o-lie process cotrol Operator-related electroic sigature Electroic lik to batch processig techology via PLC, scales, process equipmet Automated geeratio of the productio protocol PD_FIRST.ppt 17 Propack Data 2001 PRODUCTION DATA AND BATCH ARCHIVE P D B SQL-based reportig fuctios Log-term batch archive Exteral archive maagemet Documet scaig PD_FIRST.ppt 18 Propack Data

10 itro_ad_pmx.ppt PRODUCTION SCHEDULING & CONTROL E I N L O P Electroic plaig board Iterface to ERP Optimal order sequecig Optimizatio of set-up times Resource requiremets Persoel placemet pla Checkig of dates ad resources Simulatios Moitorig of order progress PD_FIRST.ppt 19 Propack Data 2001 QUALIFICATION MANAGEMENT P E P S Persoel qualificatio data Staff qualificatio, traiig admiistratio Plat- / GxP- ad SOP-related istructios Order-related placemet plaig GxP Traiig Maagemet Trigger based deviatio reportig Reports PD_FIRST.ppt 20 Propack Data

11 itro_ad_pmx.ppt QUALITY MANAGEMENT QUIBS GLP/FDA-compliat master data maagemet (check plas, check items, processes, etc.) Process-attedig i-process cotrol durig productio ad packagig at the work ceter/laboratory Samplig at goods receipt/issue as well as durig process Order processig i aalytic, microbiology ad stability laboratories (chemical/physical ad microbiological aalysis procedures) Batch cotrol ad evaluatio o the basis of research results Quality certificates/certificates of aalysis Documetatio, reports Automatic dowload of check results PD_FIRST.ppt 21 Propack Data 2001 DISPENSING AND WEIGHING SYSTEM D I S Y Idetificatio of cotaiers ad iput materials with RF-scaers Recipe-based weighig Ope scales iterfaces, automatio of dosage device Labelig, weighig protocol, batch documetatio Itegratio with EBR PD_FIRST.ppt 22 Propack Data

12 validatio_approach.ppt AGENDA INTRODUCTION COMPANY OVERVIEW PMX ARCHITECTURE VALIDATION APPROACH IMPLEMENTATION OF 21 CFR PART 11 DISCUSSION Validatio_approach / 1 Propack Data 2001 VALIDATION STRATEGY A TWO-STEP APPROACH Pre-validatio of stadard solutio package Validatio of Customer System Validatio_approach / 2 Propack Data

13 validatio_approach.ppt PRE-VALIDATION OF STANDARD PACKAGE Request Evaluatio & Release Defiitio Maiteace User Requiremet Specificatio Release Lauch Release Test Fuctioal ad Techical Specificatio Implemetatio Validatio_approach / 3 Propack Data 2001 RELEASE DOCUMENTATION Release Qualificatio Documetatio Solutio Specificatio Validatio Documetatio Package Techical ad Quality Documetatio System Documetatio Traiig Documetatio Next Validatio_approach / 4 Propack Data

14 validatio_approach.ppt TRANSFORMATION OF STANDARD SOLUTION TO CUSTOMER SYSTEM Pre-Validated Stadard Solutio Package Localizatio Cofiguratio Validatio Validated Customer System Customizatio Validatio_approach / 5 Propack Data 2001 PD-VISION - based o V-MODEL Coclusio of cotract Support User Requiremet Specificatio Deploymet Itegratio & Qualificatio Fuctioal ad Techical Specificatio Implemetatio Validatio_approach / 6 Propack Data

15 MT 630 validatio_approach.ppt TEST STRATEGY Test suite with phase specific test objective ad low redudacy betwee phases Maximum re-usability of testig Focus o chages applied to stadard software Test specificatio based o documeted risk aalysis to access impact of chages IF... REPEAT... PERFORM.. PRINT... ENDIF Validatio_approach / 7 Propack Data 2001 TEST METHOD IF... REPEAT... PERFORM.. PRINT... ENDIF order xyz Software item test System test HW-Istallatio test Iterface test Acceptace test PQ test Focus test strategy test object Software- Fuctio / Hardware Iterfaces to Busiess complete system Elemet Trasactio other systems processes i operatioal eviromet white box test black box test; check of black box test; Challege test i Challege Tests fuctioality ad Challege testig o operatioal completeess Tests process level eviromet Code for New or New or GxP - relevat GxP - relevat Chage or customized customized processes data Ehacemet Fuctios iterfaces Validatio_approach / 8 Propack Data

16 AGENDA INTRODUCTION COMPANY OVERVIEW PMX ARCHITECTURE VALIDATION APPROACH IMPLEMENTATION OF 21 CFR PART 11 DISCUSSION 21_CFR_Part_11_compact.ppt 1 Propack Data 2001 PMX FEATURES SUPPORTING 21 CFR PART 11 COMPLIANCE A Selectio: Reportig of Electroic Records Authority Checks Archivig Audit Trails Sequecig of Steps & Evets Electroic Sigature Maifestatio Sigature / Record Likig Electroic Sigature Compoets Cotrols for Idetificatio Codes / Passwords 21_CFR_Part_11_compact.ppt 2 Propack Data

17 21 CFR PART 11 REQUIREMENTS 11.10(b) The system shall provide the ability to geerate accurate ad complete copies of records i both huma readable ad electroic form suitable for ispectio, review, ad copyig by the agecy. Implemetatio i PMX Reportig Features 21_CFR_Part_11_compact.ppt 3 Propack Data CFR PART 11 REQUIREMENTS 11.10(c) The system shall esure the protectio of records to eable their accurate ad ready retrieval throughout the records retetio period (d) Limitig system access to authorized idividuals must be esured. Implemetatio i PMX User Authorizatio Access Restrictios Archivig Features 21_CFR_Part_11_compact.ppt 4 Propack Data

18 21 CFR PART 11 REQUIREMENTS 11.10(e) The system must provide secure, computer-geerated, time-stamped audit trails to idepedetly record the date ad time of operator etries ad actios that create, modify, or delete electroic records. Record chages shall ot obscure previously recorded iformatio. Implemetatio i PMX Audit Trail Versio Cotrol 21_CFR_Part_11_compact.ppt 5 Propack Data CFR PART 11 REQUIREMENTS 11.10(f) Use of operatioal system checks to eforce permitted sequecig of steps ad evets, as appropriate. Implemetatio i PMX Sequecig of Actios 21_CFR_Part_11_compact.ppt 6 Propack Data

19 21 CFR PART 11 REQUIREMENTS 11.10(g) Use of authority checks to esure that oly authorized idividuals ca use the system, electroically sig a record, access the operatio or computer system iput or output device, alter a record, or perform the operatio at had. Implemetatio i PMX User Authorizatio Certifyig Authorizatio Access Restrictios 21_CFR_Part_11_compact.ppt 7 Propack Data CFR PART 11 REQUIREMENTS 11.50(a) Siged electroic records shall cotai iformatio associated with the sigig that clearly idicates all of the followig: (1) The prited ame of the siger; (2) The date ad time whe the sigature was executed; ad (3) The meaig (such as review, approval, resposibility, or authorship) associated with the sigature. Implemetatio i PMX Sigature Maifestatio 21_CFR_Part_11_compact.ppt 8 Propack Data

20 21 CFR PART 11 REQUIREMENTS 11.50(b) Prited ame of the siger, date ad time, ad meaig associated with the sigature shall be subject to the same cotrols as for electroic records ad shall be icluded as part of ay huma readable form of the electroic record (such as electroic display or pritout). Implemetatio i PMX Maagemet ad Display of Electroic Sigatures 21_CFR_Part_11_compact.ppt 9 Propack Data CFR PART 11 REQUIREMENTS Sigature/record likig: Electroic sigatures ad hadwritte sigatures executed to electroic records shall be liked to their respective electroic records to esure that the sigatures caot be excised, copied, or otherwise trasferred to falsify a electroic record by ordiary meas. Implemetatio i PMX Sigature / Record Likig 21_CFR_Part_11_compact.ppt 10 Propack Data

21 21 CFR PART 11 REQUIREMENTS (a)(1) Electroic sigatures that are ot based upo biometrics shall employ at least two distict idetificatio compoets such as a idetificatio code ad password. Implemetatio i PMX Sigature Compoets 21_CFR_Part_11_compact.ppt 11 Propack Data CFR PART 11 REQUIREMENTS (b) The system shall provide cotrols esurig that idetificatio code ad password issuaces are periodically checked, recalled, or revised (e.g., to cover such evets as password agig). Implemetatio i PMX Password Features Reportig for User Authorizatio 21_CFR_Part_11_compact.ppt 12 Propack Data

22 Implemetatio of 21 CFR Part 11 i PMX Reportig Every electroic record ca be geerated i huma readable ad electroic form Stadard templates or customized templates 21_CFR_Part_11_compact.ppt 14 Propack Data

23 Authorizatio Two kids of Authorizatios Operatioal Authorizatio - Executio The rights required by a operator for executig a certai fuctio Certifyig Authorizatio - Approval The rights required by a supervisor/operator for certifyig that the results of a certai operatio are i order Authorizatios are associated with a Customer-specific Hierarchy of User Groups ad Users 21_CFR_Part_11_compact.ppt 15 Propack Data 2001 Access Restrictios Logi Features á Cofigurable umber of false Logi Attempts á Protocol of all Logi Attempts Password Features á Ecrypted Storage á Cofigurable expiratio á At least oe Number or Special Character á At least 6 characters log á Restrictive re-usability of passwords Cofigurable Automatic Scree Lock mechaism durig iactivity Database accessible oly through cotrolled system fuctioality 21_CFR_Part_11_compact.ppt 16 Propack Data

24 Audit Trail Comprises the Followig: A time-stamp Field ame New value withi the field Old value withi the field The kid of trasactio - (e.g. create, delete, modify) Idetificatio of the operator (logi ame) A electroic sigature, wheever appropriate The reaso for the chage, wheever appropriate Geeric Cocept withi PMX which ca be cofigured for each Record Type separately - e.g. BOM, Productio Procedure, 21_CFR_Part_11_compact.ppt 17 Propack Data 2001 Versio Cotrol Work Flow Trasitio Graph of a Versio Cotrolled Object Represets workflow for data object State trasitio is coupled with specific authorizatio ad electroic sigature Automatic versio umberig Old versios that have reached certai state are kept i archive System esures that oly oe valid object at ay oe give time exists Setup of differet approval flows for differet objects by user Expired period of validity Deletio data object Author s sigature Edit mode Test Approval Released Valid Archive No sigature Isertio ew data No sigature Stipulated period of validity ad operatioal maager s sigature Curret withi period of validity Expired period of lidi 21_CFR_Part_11_compact.ppt 18 Propack Data

25 Versio Cotrol Chage History of a Data Object 21_CFR_Part_11_compact.ppt 19 Propack Data 2001 Sequecig of Actios Sequecig eforced through basic system fuctios ad cofigurable mechaisms, as e.g. User defiable master batch record Versio graphs defiig workflow from editig to archivig Operatio workflow for recipe-based weighig 21_CFR_Part_11_compact.ppt 20 Propack Data

26 Maagemet ad Display of Electroic Sigatures Sigature compoets are displayed o every paper record/scree display as appropriate For practical reasos, sigature iformatio ca be displayed o demad 21_CFR_Part_11_compact.ppt 21 Propack Data 2001 Madatory Sigature Compoets Requiremet: Two distict idetificatio compoets User Idetificatio Code Logi Name - Uique - Associated user rights Password - Secret - protected by password features Please eter password: ****** 21_CFR_Part_11_compact.ppt 22 Propack Data

27 Recommedatio Sigature Compoets Requiremet: Two distict idetificatio compoets Logical Key user idetificatio code (ID-Code) + password + differetiated user maagemet ad rights system Physical Key e.g. Smartcard with associated ID- code 21_CFR_Part_11_compact.ppt 23 Propack Data 2001 Sigatures Maifestatio i PMX Full ame of siger stored withi user profile ad displayed i lie of idetificatio code Date ad time always stored ad displayed together with sigature Meaig of Sigatures provided by cotext of sigig, if if appropriate ( e.g. withi a workflow) provided by explicit declaratio (e.g. withi report) 21_CFR_Part_11_compact.ppt 24 Propack Data

28 Sigature / Record Likig Electroic Sigatures are liked to Electroic Records ( Data Objects) through Database Structure. DB Access is cotrolled through Database Maagemet System. Likig Hadwritte Sigatures Cotrol of Pritouts: Uique, successive umberig of copies 21_CFR_Part_11_compact.ppt 25 Propack Data 2001 Uiqueess of Sigatures PMX refuses o-uique user Idetificatio Codes User accouts that have bee used caot be deleted 21_CFR_Part_11_compact.ppt 26 Propack Data

29 Protectio from Fraud System Features to prevet Fraud: Secure Password Features Access to Database oly through System Fuctios System Admiistrator has o kowledge of Passwords 21_CFR_Part_11_compact.ppt 27 Propack Data 2001 Password Features Ecrypted Storage Hidde etry of password o scree Cofigurable Expiratio At least oe Number or Special Character At least 6 Characters log Restrictive re-usability of passwords 21_CFR_Part_11_compact.ppt 28 Propack Data

30 Reportig for User Authorizatio Reportig fuctios for user / user group data available, displayig the rights of each user group ad the correspodece of users to user groups 21_CFR_Part_11_compact.ppt 29 Propack Data 2001 Certifyig Authorizatio - Implemetatio Ca be boud to Trasactios such as Completio of a Operatio step - Batch Recordig, Moitorig, Weighig ad Dispesig Chagig the Status of a Documet uder Versio Cotrol Activatio of Iteractio Elemets Certifyig Rights are also Associated with either User Groups or Users 21_CFR_Part_11_compact.ppt 30 Propack Data

31 Archivig i PMX - Cocepts Productive- Datebase (relatioal) Archival Stage 1 Archive- Datebase (relatioal) Archival Stage 2 Log-term Archive (Data-orieted) Archived Active data Active data Data with all depedet with all depedet Objects Objects Time medium term, log term, cyclic cyclic Data format / 1:1-image of the Stadardized Storage Media Structure i the Data formats Productive Database / XML, HTML, PDF, / Hard Disks CD, DMS, Iformatio cotet Complete compressed Iformatio cotet of represetatio Productive Database of the iformatio Access Methods PMX Data-Viewer DMS 21_CFR_Part_11_compact.ppt 31 Propack Data