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Pharmaceutical computer systems validation : quality assurance, risk management and regulatory compliance / / edited by Guy Wingate
| Pharmaceutical computer systems validation : quality assurance, risk management and regulatory compliance / / edited by Guy Wingate |
| Edizione | [2nd ed.] |
| Pubbl/distr/stampa | New York : , : Informa Healthcare, , 2010 |
| Descrizione fisica | 1 online resource (773 p.) |
| Disciplina |
615.1068/4
615.10684 |
| Altri autori (Persone) | WingateGuy |
| Soggetto topico |
Pharmaceutical industry - Management
Pharmaceutical industry - Data processing Health facilities - Risk management Risk management - Data processing |
| Soggetto genere / forma | Electronic books. |
| ISBN |
0-429-13762-1
1-282-56102-2 9786612561023 1-4200-8895-5 |
| Formato | Materiale a stampa  |
| Livello bibliografico | Monografia |
| Lingua di pubblicazione | eng |
| Nota di contenuto |
Front Cover; Foreword to the Second Edition; Foreword to the First Edition; Preface; Contributor Biographies; Abbreviations; Contents; Chapter 1. Introduction; Chapter 2. Organization and Management; Chapter 3. Supporting Processes; Chapter 4. Prospective Verification and Validation; Chapter 5. Project Initiation and Compliance Determination; Chapter 6. Requirements Capture and Supplier (Vendor)Selection; Chapter 7. Design and Development; Chapter 8. Coding, Configuration, and Build; Chapter 9. Development Testing; Chapter 10. User Qualification and Authorization to Use
Chapter 11. Operation and MaintenanceChapter 12. Phaseout and Withdrawal; Chapter 13. Electronic Records and Electronic Signatures; Chapter 14. Regulatory Inspections; Chapter 15. Compliance Strategies; Chapter 16. Capabilities, Measures, and Performance; Chapter 17. Practical Troubleshooting; Chapter 18. Concluding Remarks; Chapter 19. Case Study 1: Computerized Analytical Laboratory Systems; Chapter 20. Case Study 2: Chromatography Data Systems; Chapter 21. Case Study 3: Laboratory Information Management Systems; Chapter 22. Case Study 4: Clinical Systems Chapter 23. Case Study 5: Control and Monitoring InstrumentationChapter 24. Case Study 6: Process Control Systems; Chapter 25. Case Study 7: Manufacturing Execution Systems and Electronic Batch Records; Chapter 26. Case Study 8: Building Management Systems; Chapter 27. Case Study 9: Engineering Management Systems; Chapter 28. Case Study 10: Desktop Applications Including Spreadsheets; Chapter 29. Case Study 11: Databases; Chapter 30. Case Study 12: Electronic Document Management Systems; Chapter 31. Case Study 13: Enterprise Resource Planning Systems Chapter 32. Case Study 14: Marketing and Supply ApplicationsChapter 33. Case Study 15: IT Infrastructure and Associated Services; Chapter 34. Case Study 16: Internet/Intranet Applications; Chapter 35. Case Study 17: Medical Devices and Their Automated Manufacture; Chapter 36. Case Study 18: Blood Establishment Computer Systems; Chapter 37. Case Study 19: Process Analytical Technology; Chapter 38. Case Study 20: Computer Applications Supporting the Supply of Biotechnology Products; Glossary; Back Cover |
| Record Nr. | UNINA-9910459271703321 |
| New York : , : Informa Healthcare, , 2010 | ||
| Materiale a stampa | ||
| Lo trovi qui: Univ. Federico II | ||
| ||
Pharmaceutical computer systems validation : quality assurance, risk management and regulatory compliance / / edited by Guy Wingate
| Pharmaceutical computer systems validation : quality assurance, risk management and regulatory compliance / / edited by Guy Wingate |
| Edizione | [2nd ed.] |
| Pubbl/distr/stampa | New York : , : Informa Healthcare, , 2010 |
| Descrizione fisica | 1 online resource (773 p.) |
| Disciplina |
615.1068/4
615.10684 |
| Altri autori (Persone) | WingateGuy |
| Soggetto topico |
Pharmaceutical industry - Management
Pharmaceutical industry - Data processing Health facilities - Risk management Risk management - Data processing |
| ISBN |
0-429-13762-1
1-282-56102-2 9786612561023 1-4200-8895-5 |
| Formato | Materiale a stampa |
| Livello bibliografico | Monografia |
| Lingua di pubblicazione | eng |
| Nota di contenuto |
Front Cover; Foreword to the Second Edition; Foreword to the First Edition; Preface; Contributor Biographies; Abbreviations; Contents; Chapter 1. Introduction; Chapter 2. Organization and Management; Chapter 3. Supporting Processes; Chapter 4. Prospective Verification and Validation; Chapter 5. Project Initiation and Compliance Determination; Chapter 6. Requirements Capture and Supplier (Vendor)Selection; Chapter 7. Design and Development; Chapter 8. Coding, Configuration, and Build; Chapter 9. Development Testing; Chapter 10. User Qualification and Authorization to Use
Chapter 11. Operation and MaintenanceChapter 12. Phaseout and Withdrawal; Chapter 13. Electronic Records and Electronic Signatures; Chapter 14. Regulatory Inspections; Chapter 15. Compliance Strategies; Chapter 16. Capabilities, Measures, and Performance; Chapter 17. Practical Troubleshooting; Chapter 18. Concluding Remarks; Chapter 19. Case Study 1: Computerized Analytical Laboratory Systems; Chapter 20. Case Study 2: Chromatography Data Systems; Chapter 21. Case Study 3: Laboratory Information Management Systems; Chapter 22. Case Study 4: Clinical Systems Chapter 23. Case Study 5: Control and Monitoring InstrumentationChapter 24. Case Study 6: Process Control Systems; Chapter 25. Case Study 7: Manufacturing Execution Systems and Electronic Batch Records; Chapter 26. Case Study 8: Building Management Systems; Chapter 27. Case Study 9: Engineering Management Systems; Chapter 28. Case Study 10: Desktop Applications Including Spreadsheets; Chapter 29. Case Study 11: Databases; Chapter 30. Case Study 12: Electronic Document Management Systems; Chapter 31. Case Study 13: Enterprise Resource Planning Systems Chapter 32. Case Study 14: Marketing and Supply ApplicationsChapter 33. Case Study 15: IT Infrastructure and Associated Services; Chapter 34. Case Study 16: Internet/Intranet Applications; Chapter 35. Case Study 17: Medical Devices and Their Automated Manufacture; Chapter 36. Case Study 18: Blood Establishment Computer Systems; Chapter 37. Case Study 19: Process Analytical Technology; Chapter 38. Case Study 20: Computer Applications Supporting the Supply of Biotechnology Products; Glossary; Back Cover |
| Record Nr. | UNINA-9910792350003321 |
| New York : , : Informa Healthcare, , 2010 | ||
| Materiale a stampa | ||
| Lo trovi qui: Univ. Federico II | ||
| ||
Pharmaceutical computer systems validation : quality assurance, risk management and regulatory compliance / / edited by Guy Wingate
| Pharmaceutical computer systems validation : quality assurance, risk management and regulatory compliance / / edited by Guy Wingate |
| Edizione | [2nd ed.] |
| Pubbl/distr/stampa | New York : , : Informa Healthcare, , 2010 |
| Descrizione fisica | 1 online resource (773 p.) |
| Disciplina |
615.1068/4
615.10684 |
| Altri autori (Persone) | WingateGuy |
| Soggetto topico |
Pharmaceutical industry - Management
Pharmaceutical industry - Data processing Health facilities - Risk management Risk management - Data processing |
| ISBN |
0-429-13762-1
1-282-56102-2 9786612561023 1-4200-8895-5 |
| Formato | Materiale a stampa |
| Livello bibliografico | Monografia |
| Lingua di pubblicazione | eng |
| Nota di contenuto |
Front Cover; Foreword to the Second Edition; Foreword to the First Edition; Preface; Contributor Biographies; Abbreviations; Contents; Chapter 1. Introduction; Chapter 2. Organization and Management; Chapter 3. Supporting Processes; Chapter 4. Prospective Verification and Validation; Chapter 5. Project Initiation and Compliance Determination; Chapter 6. Requirements Capture and Supplier (Vendor)Selection; Chapter 7. Design and Development; Chapter 8. Coding, Configuration, and Build; Chapter 9. Development Testing; Chapter 10. User Qualification and Authorization to Use
Chapter 11. Operation and MaintenanceChapter 12. Phaseout and Withdrawal; Chapter 13. Electronic Records and Electronic Signatures; Chapter 14. Regulatory Inspections; Chapter 15. Compliance Strategies; Chapter 16. Capabilities, Measures, and Performance; Chapter 17. Practical Troubleshooting; Chapter 18. Concluding Remarks; Chapter 19. Case Study 1: Computerized Analytical Laboratory Systems; Chapter 20. Case Study 2: Chromatography Data Systems; Chapter 21. Case Study 3: Laboratory Information Management Systems; Chapter 22. Case Study 4: Clinical Systems Chapter 23. Case Study 5: Control and Monitoring InstrumentationChapter 24. Case Study 6: Process Control Systems; Chapter 25. Case Study 7: Manufacturing Execution Systems and Electronic Batch Records; Chapter 26. Case Study 8: Building Management Systems; Chapter 27. Case Study 9: Engineering Management Systems; Chapter 28. Case Study 10: Desktop Applications Including Spreadsheets; Chapter 29. Case Study 11: Databases; Chapter 30. Case Study 12: Electronic Document Management Systems; Chapter 31. Case Study 13: Enterprise Resource Planning Systems Chapter 32. Case Study 14: Marketing and Supply ApplicationsChapter 33. Case Study 15: IT Infrastructure and Associated Services; Chapter 34. Case Study 16: Internet/Intranet Applications; Chapter 35. Case Study 17: Medical Devices and Their Automated Manufacture; Chapter 36. Case Study 18: Blood Establishment Computer Systems; Chapter 37. Case Study 19: Process Analytical Technology; Chapter 38. Case Study 20: Computer Applications Supporting the Supply of Biotechnology Products; Glossary; Back Cover |
| Record Nr. | UNINA-9910800061903321 |
| New York : , : Informa Healthcare, , 2010 | ||
| Materiale a stampa | ||
| Lo trovi qui: Univ. Federico II | ||
| ||
Pharmaceutical computer systems validation : quality assurance, risk management and regulatory compliance / / edited by Guy Wingate
| Pharmaceutical computer systems validation : quality assurance, risk management and regulatory compliance / / edited by Guy Wingate |
| Edizione | [2nd ed.] |
| Pubbl/distr/stampa | New York, : Informa Healthcare, c2010 |
| Descrizione fisica | 1 online resource (773 p.) |
| Disciplina |
615.1068/4
615.10684 |
| Altri autori (Persone) | WingateGuy |
| Soggetto topico |
Pharmaceutical industry - Management
Pharmaceutical industry - Data processing Health facilities - Risk management Risk management - Data processing |
| ISBN |
0-429-13762-1
1-282-56102-2 9786612561023 1-4200-8895-5 9780429137624 |
| Formato | Materiale a stampa |
| Livello bibliografico | Monografia |
| Lingua di pubblicazione | eng |
| Nota di contenuto |
Front Cover; Foreword to the Second Edition; Foreword to the First Edition; Preface; Contributor Biographies; Abbreviations; Contents; Chapter 1. Introduction; Chapter 2. Organization and Management; Chapter 3. Supporting Processes; Chapter 4. Prospective Verification and Validation; Chapter 5. Project Initiation and Compliance Determination; Chapter 6. Requirements Capture and Supplier (Vendor)Selection; Chapter 7. Design and Development; Chapter 8. Coding, Configuration, and Build; Chapter 9. Development Testing; Chapter 10. User Qualification and Authorization to Use
Chapter 11. Operation and MaintenanceChapter 12. Phaseout and Withdrawal; Chapter 13. Electronic Records and Electronic Signatures; Chapter 14. Regulatory Inspections; Chapter 15. Compliance Strategies; Chapter 16. Capabilities, Measures, and Performance; Chapter 17. Practical Troubleshooting; Chapter 18. Concluding Remarks; Chapter 19. Case Study 1: Computerized Analytical Laboratory Systems; Chapter 20. Case Study 2: Chromatography Data Systems; Chapter 21. Case Study 3: Laboratory Information Management Systems; Chapter 22. Case Study 4: Clinical Systems Chapter 23. Case Study 5: Control and Monitoring InstrumentationChapter 24. Case Study 6: Process Control Systems; Chapter 25. Case Study 7: Manufacturing Execution Systems and Electronic Batch Records; Chapter 26. Case Study 8: Building Management Systems; Chapter 27. Case Study 9: Engineering Management Systems; Chapter 28. Case Study 10: Desktop Applications Including Spreadsheets; Chapter 29. Case Study 11: Databases; Chapter 30. Case Study 12: Electronic Document Management Systems; Chapter 31. Case Study 13: Enterprise Resource Planning Systems Chapter 32. Case Study 14: Marketing and Supply ApplicationsChapter 33. Case Study 15: IT Infrastructure and Associated Services; Chapter 34. Case Study 16: Internet/Intranet Applications; Chapter 35. Case Study 17: Medical Devices and Their Automated Manufacture; Chapter 36. Case Study 18: Blood Establishment Computer Systems; Chapter 37. Case Study 19: Process Analytical Technology; Chapter 38. Case Study 20: Computer Applications Supporting the Supply of Biotechnology Products; Glossary; Back Cover |
| Record Nr. | UNINA-9911104294403321 |
| New York, : Informa Healthcare, c2010 | ||
| Materiale a stampa | ||
| Lo trovi qui: Univ. Federico II | ||
| ||
Pharmaceutical computer systems validation : quality assurance, risk management and regulatory compliance / / edited by Guy Wingate
| Pharmaceutical computer systems validation : quality assurance, risk management and regulatory compliance / / edited by Guy Wingate |
| Edizione | [2nd ed.] |
| Pubbl/distr/stampa | New York, : Informa Healthcare, c2010 |
| Descrizione fisica | 1 online resource (773 p.) |
| Disciplina |
615.1068/4
615.10684 |
| Altri autori (Persone) | WingateGuy |
| Soggetto topico |
Pharmaceutical industry - Management
Pharmaceutical industry - Data processing Health facilities - Risk management Risk management - Data processing |
| ISBN |
0-429-13762-1
1-282-56102-2 9786612561023 1-4200-8895-5 9780429137624 |
| Formato | Materiale a stampa |
| Livello bibliografico | Monografia |
| Lingua di pubblicazione | eng |
| Nota di contenuto |
Front Cover; Foreword to the Second Edition; Foreword to the First Edition; Preface; Contributor Biographies; Abbreviations; Contents; Chapter 1. Introduction; Chapter 2. Organization and Management; Chapter 3. Supporting Processes; Chapter 4. Prospective Verification and Validation; Chapter 5. Project Initiation and Compliance Determination; Chapter 6. Requirements Capture and Supplier (Vendor)Selection; Chapter 7. Design and Development; Chapter 8. Coding, Configuration, and Build; Chapter 9. Development Testing; Chapter 10. User Qualification and Authorization to Use
Chapter 11. Operation and MaintenanceChapter 12. Phaseout and Withdrawal; Chapter 13. Electronic Records and Electronic Signatures; Chapter 14. Regulatory Inspections; Chapter 15. Compliance Strategies; Chapter 16. Capabilities, Measures, and Performance; Chapter 17. Practical Troubleshooting; Chapter 18. Concluding Remarks; Chapter 19. Case Study 1: Computerized Analytical Laboratory Systems; Chapter 20. Case Study 2: Chromatography Data Systems; Chapter 21. Case Study 3: Laboratory Information Management Systems; Chapter 22. Case Study 4: Clinical Systems Chapter 23. Case Study 5: Control and Monitoring InstrumentationChapter 24. Case Study 6: Process Control Systems; Chapter 25. Case Study 7: Manufacturing Execution Systems and Electronic Batch Records; Chapter 26. Case Study 8: Building Management Systems; Chapter 27. Case Study 9: Engineering Management Systems; Chapter 28. Case Study 10: Desktop Applications Including Spreadsheets; Chapter 29. Case Study 11: Databases; Chapter 30. Case Study 12: Electronic Document Management Systems; Chapter 31. Case Study 13: Enterprise Resource Planning Systems Chapter 32. Case Study 14: Marketing and Supply ApplicationsChapter 33. Case Study 15: IT Infrastructure and Associated Services; Chapter 34. Case Study 16: Internet/Intranet Applications; Chapter 35. Case Study 17: Medical Devices and Their Automated Manufacture; Chapter 36. Case Study 18: Blood Establishment Computer Systems; Chapter 37. Case Study 19: Process Analytical Technology; Chapter 38. Case Study 20: Computer Applications Supporting the Supply of Biotechnology Products; Glossary; Back Cover |
| Record Nr. | UNINA-9911137436103321 |
| New York, : Informa Healthcare, c2010 | ||
| Materiale a stampa | ||
| Lo trovi qui: Univ. Federico II | ||
| ||