ACHIEVING SERIALIZED PRODUCT TRACEABILITYFOR QUALITY & SAFETYFacing Compliance Requirements in the Pharmaceutical Industry...
Company                         Deutsche Blister Union                            (German Blister Union)ACE 2011 INTERNATI...
Medication SupplyProblem:        In 2009 we had 15 million hospital patients         and 25 million in old people’s retir...
Existing Process of Medication Supply                                                               Patient               ...
Legal LiabilityThe risk for the CEO and the entire management is:                                                   Up to ...
What Does „Blistering“ Mean? Solid, oral medication are provided in a one-week dispenser Patient-individual medication s...
Performance Characteristics Capacity per site:                   Minimum 3,000 patients/week Total capacity of the DBU n...
Serialized Unit Packaging InformationName & date of birthof the patient                                        Hospital wa...
Deutsche Blister Union Service provider of dose-dispensed  medicine Germany-wide merger of blister  pharmacies, regional...
Old Verification Process in Blister PackProduction Documentation of the production process with production protocols     ...
New Process for Medication Supply                                                                                  Patient...
Benefits Care facility                              Patient        Safe provision of medication            High level ...
DataSquare‘s Challenge Ensurance of legally valid signature Integration of a signature component Re-writing of parts of...
New Verification Process in Blister PackProduction Automation of the production process        Digital control and docum...
Aras Innovator‘s TaskACE 2011 INTERNATIONAL   Slide 15
Workflow Control in Aras InnovatorACE 2011 INTERNATIONAL               Slide 16
Signature Request Software approved by the Federal Office for Information Security (Bundesamt für  Sicherheit) A batch i...
Electronic Signature Process                                A “container“ is placed around the                           ...
PIN Code Entry The PIN code is entered via the smartcard terminal‘s keyboard The signature is created by pressing the gr...
Data Transfer to Aras Innovator                                  Portrayal of the signature status in                     ...
Production ProtocolsACE 2011 INTERNATIONAL   Slide 21
Re-entry of Paper Protocols                               Automatic text recognition by                                OC...
Time TakenIn comparison to other PLM Systems: 2 to 3 times faster!ACE 2011 INTERNATIONAL                                 S...
Benefits Management                                          Legal requirements           Centralized control and monit...
Many Thanks for your AttentionYour DataSquare TeamDataSquare GmbH & Co. KGHamburg/Germanyinfo@datasquare.dewww.datasquare.de
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Deutsche Blisterunion Germany Achieves Serialized Product Traceability with PLM from Aras Deployed by Datasquare

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Deutsche Blisterunion Achieves Serialized Product Traceability for Quality and Safety with PLM using Aras implemented by Datasquare

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Deutsche Blisterunion Germany Achieves Serialized Product Traceability with PLM from Aras Deployed by Datasquare

  1. 1. ACHIEVING SERIALIZED PRODUCT TRACEABILITYFOR QUALITY & SAFETYFacing Compliance Requirements in the Pharmaceutical Industryand Personal Liability of the ManagementJoachim MisdorfCEO DataSquareHamburg, Germany
  2. 2. Company Deutsche Blister Union (German Blister Union)ACE 2011 INTERNATIONAL Slide 2
  3. 3. Medication SupplyProblem:  In 2009 we had 15 million hospital patients and 25 million in old people’s retirement & nursing homes worldwide (source: wikipedia)  Most of these patients need medication every dayCurrent solution:  Thousands of nurses put pills into small pillboxes by hand every morningConsequence:  Procedure is very expensive  High Error Rate: Patients become ill or even die due to medication or dosage errorsACE 2011 INTERNATIONAL Slide 3
  4. 4. Existing Process of Medication Supply Patient PharmacyPrescriptions Medication in Patient transport packaging Patient Medication lists Nursing Doctor Patient staff Medication Hospital, distributed Retirement & by hand!!! Patient Nursing Home, Care Home ACE 2011 INTERNATIONAL Slide 4
  5. 5. Legal LiabilityThe risk for the CEO and the entire management is: Up to lifelong prison terms (US = lifelong / Europe = 10 years) plus full personal financial liability (worldwide) for failure to follow the regulations for medication supply US Food and Drug Administration (FDA) European Medicines Agency (EMA) Plus local lawsACE 2011 INTERNATIONAL Slide 5
  6. 6. What Does „Blistering“ Mean? Solid, oral medication are provided in a one-week dispenser Patient-individual medication supply  Name  Date & time  Kind of drugACE 2011 INTERNATIONAL Slide 6
  7. 7. Performance Characteristics Capacity per site: Minimum 3,000 patients/week Total capacity of the DBU network: Approx. 60,000 patients/week (Expansion stage 1) Quality Assurance: Use of video scanners (each blister pack is photographed, analyzed and archived) Drug safety: Patient information leaflet and tablet photo service Training: Comprehensive training courses for nursing staff, patients and their relativesACE 2011 INTERNATIONAL Slide 7
  8. 8. Serialized Unit Packaging InformationName & date of birthof the patient Hospital ward Date & time of takingDosage & name ofthe drug Kind of drug Product Code for Aras InnovatorACE 2011 INTERNATIONAL Slide 8
  9. 9. Deutsche Blister Union Service provider of dose-dispensed medicine Germany-wide merger of blister pharmacies, regionally operating blister centers and industrial companies Offers service on all aspects of the mechanical blistering of drugs for the individual patient Founded in 2008 32 blister centers all over Germany in 2011 Market activities in the US since 2011ACE 2011 INTERNATIONAL Slide 9
  10. 10. Old Verification Process in Blister PackProduction Documentation of the production process with production protocols  Distribution to “qualified persons“ (QP) throughout Germany  Protocols verified by QPs  QPs sign the protocols by hand to signify approval  Archived for over 10 years or for life / amount of paper increasing substantially QP QP Protocols sent for verification QP QP Production Protocols returned after verification QP QP Approved protocols archived Archive Takes a lot of time and very inflexible!ACE 2011 INTERNATIONAL Slide 10
  11. 11. New Process for Medication Supply Patient Pharmacy Digitalization of prescriptions MedicationPrescriptions lists Patient Patient Blimus - Software Doctor Patient Nursing staff Medication Hospital, distributed by Retirement & dispensers Patient Nursing Home, Care Home ACE 2011 INTERNATIONAL Slide 11
  12. 12. Benefits Care facility  Patient  Safe provision of medication  High level of medication safety  High level of medication safety  Easy, convenient administration  Lower stock of medication at the  No confusion between medications nursing station or dosage times  Automated range calculation,  Continuous dosage and timely coordination of prescription reminders of necessary management prescription refills  Patient-individual monitoring of  Simpler control of the time of medication for interactions administration and dosage  Increased pharmaceutical safety  Greater mobility and flexibility (vacation blister packs)  Return of blister packs while complying with legal privacy requirements  Lot tracking of each individual blister packACE 2011 INTERNATIONAL Slide 12
  13. 13. DataSquare‘s Challenge Ensurance of legally valid signature Integration of a signature component Re-writing of parts of the old software A very tight time table Development of the Aras Innovator Signature Connector  Protocols can be provided with qualified electronic signatures for legally valid undersigning  Signature software and hardware is integrated in Aras Innovator  Signature process is controlled by Aras Innovator  Operation through the Aras Innovator client and entry of a PIN code at the terminalACE 2011 INTERNATIONAL Slide 13
  14. 14. New Verification Process in Blister PackProduction Automation of the production process  Digital control and documentation of the verification and approval processes  All-digital management and legally compliant archiving of the production protocols Entire Data Management in Aras Innovator Service Production Pictures Archive Protocols Workflows CertificationsACE 2011 INTERNATIONAL Slide 14
  15. 15. Aras Innovator‘s TaskACE 2011 INTERNATIONAL Slide 15
  16. 16. Workflow Control in Aras InnovatorACE 2011 INTERNATIONAL Slide 16
  17. 17. Signature Request Software approved by the Federal Office for Information Security (Bundesamt für Sicherheit) A batch is approved by a Qualified Person affixing authorized electronic signature to an approval protocol Aras Innovator clears the drugs for dispatch and initiates shipment of the specific batch via the workflow system; however, it does not create the signature and is not able to check this The signature must be created and checked by certified software; OpenLimit SignCubes software is used in the Aras Innovator Signature Connector for this purpose Aras Innovator automatically accesses this softwareACE 2011 INTERNATIONAL Slide 17
  18. 18. Electronic Signature Process  A “container“ is placed around the document; the signature is embedded in the container by the signature software (The hash value is encrypted by the smartcard‘s private key)  The container becomes invalid if there is any subsequent interference  This change is immediately recognized and notified  International security certification: Common Criteria EAL4+ACE 2011 INTERNATIONAL Slide 18
  19. 19. PIN Code Entry The PIN code is entered via the smartcard terminal‘s keyboard The signature is created by pressing the green button after entering the complete PINACE 2011 INTERNATIONAL Slide 19
  20. 20. Data Transfer to Aras Innovator Portrayal of the signature status in Aras Innovator lifecycleACE 2011 INTERNATIONAL Slide 20
  21. 21. Production ProtocolsACE 2011 INTERNATIONAL Slide 21
  22. 22. Re-entry of Paper Protocols  Automatic text recognition by OCR  Protocols automatically allocated and sorted in Aras Innovator by code recognition  Data automatically saved in Aras InnovatorACE 2011 INTERNATIONAL Slide 22
  23. 23. Time TakenIn comparison to other PLM Systems: 2 to 3 times faster!ACE 2011 INTERNATIONAL Slide 23
  24. 24. Benefits Management  Legal requirements  Centralized control and monitoring and  Personal liability of the entire therefore speeding up management of all processes  Medical technology is shaped by a very  Orders distributed to DBU blister large number of legal requirements centers throughout Germany depending  The personal signature of a QP is on their workload required by law  Time and costs minimized  Legal obligation to retain documents for Resources 10 years  Qualified Persons (QPs) very expensive  Ongoing audits by the Association of Statutory Health Insurance Physicians  Several blister centers served by one (KV) and Health Ministries QP  cost sharing  Orders rapidly transferred to other  Operation QPs in the event of illness or holiday  Unskilled staff can be employed in the Blister Center IT  Significantly less paper  Central hosting  All orders processed faster  Low maintenance requirement and less expenseACE 2011 INTERNATIONAL Slide 24
  25. 25. Many Thanks for your AttentionYour DataSquare TeamDataSquare GmbH & Co. KGHamburg/Germanyinfo@datasquare.dewww.datasquare.de

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