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Collaborative computational technologies for biomedical research [[electronic resource] /] / edited by Sean Ekins, Maggie A.Z. Hupcey, [and] Antony J. Williams
| Collaborative computational technologies for biomedical research [[electronic resource] /] / edited by Sean Ekins, Maggie A.Z. Hupcey, [and] Antony J. Williams |
| Pubbl/distr/stampa | Hoboken, N.J., : Wiley, c2011 |
| Descrizione fisica | 1 online resource (572 p.) |
| Disciplina |
615.19
615/.19 |
| Altri autori (Persone) |
EkinsSean
HupceyMaggie A <1972-> (Maggie Anne Zoë) WilliamsAntony J |
| Collana | Wiley series on technologies for the pharmaceutical industry |
| Soggetto topico |
Drug development
Cooperation Pharmaceutical industry - Data processing Cloud computing |
| Soggetto genere / forma | Electronic books. |
| ISBN |
1-283-23972-8
9786613239723 1-118-02602-0 1-118-02601-2 1-118-02603-9 |
| Formato | Materiale a stampa  |
| Livello bibliografico | Monografia |
| Lingua di pubblicazione | eng |
| Nota di contenuto | pt. 1. Getting people to collaborate -- pt. 2. Methods and processes for collaborations -- pt. 3. Tools for collaborations -- pt. 4. The future of collaborations. |
| Record Nr. | UNINA-9910131022503321 |
| Hoboken, N.J., : Wiley, c2011 | ||
| Materiale a stampa | ||
| Lo trovi qui: Univ. Federico II | ||
| ||
Collaborative computational technologies for biomedical research [[electronic resource] /] / edited by Sean Ekins, Maggie A.Z. Hupcey, [and] Antony J. Williams
| Collaborative computational technologies for biomedical research [[electronic resource] /] / edited by Sean Ekins, Maggie A.Z. Hupcey, [and] Antony J. Williams |
| Pubbl/distr/stampa | Hoboken, N.J., : Wiley, c2011 |
| Descrizione fisica | 1 online resource (572 p.) |
| Disciplina |
615.19
615/.19 |
| Altri autori (Persone) |
EkinsSean
HupceyMaggie A <1972-> (Maggie Anne Zoë) WilliamsAntony J |
| Collana | Wiley series on technologies for the pharmaceutical industry |
| Soggetto topico |
Drug development
Cooperation Pharmaceutical industry - Data processing Cloud computing |
| ISBN |
1-283-23972-8
9786613239723 1-118-02602-0 1-118-02601-2 1-118-02603-9 |
| Formato | Materiale a stampa |
| Livello bibliografico | Monografia |
| Lingua di pubblicazione | eng |
| Nota di contenuto | pt. 1. Getting people to collaborate -- pt. 2. Methods and processes for collaborations -- pt. 3. Tools for collaborations -- pt. 4. The future of collaborations. |
| Record Nr. | UNINA-9910830510803321 |
| Hoboken, N.J., : Wiley, c2011 | ||
| Materiale a stampa | ||
| Lo trovi qui: Univ. Federico II | ||
| ||
Collaborative computational technologies for biomedical research / / edited by Sean Ekins, Maggie A.Z. Hupcey, [and] Antony J. Williams
| Collaborative computational technologies for biomedical research / / edited by Sean Ekins, Maggie A.Z. Hupcey, [and] Antony J. Williams |
| Pubbl/distr/stampa | Hoboken, N.J., : Wiley, c2011 |
| Descrizione fisica | 1 online resource (572 p.) |
| Disciplina | 615/.19 |
| Altri autori (Persone) |
EkinsSean
HupceyMaggie A <1972-> (Maggie Anne Zoe) WilliamsAntony J |
| Collana | Wiley series on technologies for the pharmaceutical industry |
| Soggetto topico |
Drug development
Cooperation Pharmaceutical industry - Data processing Cloud computing |
| ISBN |
1-283-23972-8
9786613239723 1-118-02602-0 1-118-02601-2 1-118-02603-9 |
| Formato | Materiale a stampa |
| Livello bibliografico | Monografia |
| Lingua di pubblicazione | eng |
| Nota di contenuto | pt. 1. Getting people to collaborate -- pt. 2. Methods and processes for collaborations -- pt. 3. Tools for collaborations -- pt. 4. The future of collaborations. |
| Record Nr. | UNINA-9910877591503321 |
| Hoboken, N.J., : Wiley, c2011 | ||
| Materiale a stampa | ||
| Lo trovi qui: Univ. Federico II | ||
| ||
Computer applications in pharmaceutical research and development [[electronic resource] /] / [edited by] Sean Ekins
| Computer applications in pharmaceutical research and development [[electronic resource] /] / [edited by] Sean Ekins |
| Pubbl/distr/stampa | Hoboken, N.J., : Wiley-Interscience, c2006 |
| Descrizione fisica | 1 online resource (840 p.) |
| Disciplina |
615.0285
615/.10285 |
| Altri autori (Persone) | EkinsSean |
| Collana | Wiley series in drug discovery and development |
| Soggetto topico |
Pharmacy - Data processing
Pharmacology - Data processing Pharmaceutical industry - Data processing |
| Soggetto genere / forma | Electronic books. |
| ISBN |
1-280-46840-8
9786610468409 0-470-03723-7 0-470-03722-9 |
| Formato | Materiale a stampa |
| Livello bibliografico | Monografia |
| Lingua di pubblicazione | eng |
| Nota di contenuto |
The history of computers in pharmaceutical research and development: a narrative / Donald B. Boyd and Max M. Marsh -- Computers as data analysis and data management tools in preclinical development / Weiyong Li and Kenneth Banks -- Statistical modeling in pharmaceutical research and development / Andrea de Gaetano ... [et al.] -- Drug discovery from historic herbal texts / Eric J. Buenz -- Contextualizing the impact of bioinformatics on preclinical drug and vaccine discovery / Darren R. Flower -- Systems approaches for pharmaceutical research and development / Sean Ekins and Craig Giroux -- Information management-biodata in life sciences / Richard K. Scott and Anthony Parsons -- Chemoinformatics techniques for processing chemical structure databases / Valerie J. Gillet and Peter Willett -- Electronic laboratory notebooks / Alfred Nehme and Robert A. Scoffin -- Strategies for using information effectively in early-stage drug discovery / David J. Wild -- Improving the pharmaceutical R&D process: how simulation can support management decision making / Andrew Chadwick ... [et al.] --
Computers and protein crystallography / David J. Edwards and Roderick E. Hubbard -- Computers, cheminformatics, and the medicinal chemist / Weifan Zheng and Michael Jones -- The challenges of making useful protein-ligand free energy predictions for drug discovery / Jun Shimada -- Computer algorithms for selecting molecule libraries for synthesis / Konstantin V. Balakin, Nikolay P. Savchuk, and Alex Kiselyov -- Success stories of computer-aided design / Hugo Kubinyi -- Pharmaceutical research and development productivity: can software help? / Christophe Lambert and S. Stanley Young -- Computer methods for predicting drug metabolism / Sean Ekins -- Computers in toxicology and risk assessment / John C. Dearden -- Computational modeling of drug disposition / Cheng Chang and Peter W. Swaan -- Computer simulations in pharmacokinetics and pharmacodynamics: rediscovering systems physiology in the 21st century / Paolo Vicini -- Predictive models for better decisions from understanding physiology to optimizing trial design / James R. Bosley, Jr -- Making pharmaceutical development more efficient / Michael Rosenberg and Richard Farris -- Use of interactive software in medical decision making / Renée J. Goldberg Arnold -- Clinical data collection and management / Mazen Abdellatif -- Regulation of computer systems / Sandy Weinberg -- A new paradigm for analyzing adverse drug events / Ana Szarfman, Jonathan G. Levine and Joseph M. Tonning -- Computers in pharmaceutical formulation / Raymond C. Rowe and Elizabeth A. Colbourn -- Legal protection of innovative uses of computers in R&D / Robert Harrison -- The ethics of computing in pharmaceutical research / Matthew K. McGowan and Richard J. McGowan -- The UltraLink: an expert system for contextual hyperlinking in knowledge management / Martin Romacker ... [et al.] -- Powerful, predictive and pervasive: the future of computers in the pharmaceutical industry / Nick Davies, Heather Ahlborn, Stuart Henderson. |
| Record Nr. | UNINA-9910143409403321 |
| Hoboken, N.J., : Wiley-Interscience, c2006 | ||
| Materiale a stampa | ||
| Lo trovi qui: Univ. Federico II | ||
| ||
Computer applications in pharmaceutical research and development [[electronic resource] /] / [edited by] Sean Ekins
| Computer applications in pharmaceutical research and development [[electronic resource] /] / [edited by] Sean Ekins |
| Pubbl/distr/stampa | Hoboken, N.J., : Wiley-Interscience, c2006 |
| Descrizione fisica | 1 online resource (840 p.) |
| Disciplina |
615.0285
615/.10285 |
| Altri autori (Persone) | EkinsSean |
| Collana | Wiley series in drug discovery and development |
| Soggetto topico |
Pharmacy - Data processing
Pharmacology - Data processing Pharmaceutical industry - Data processing |
| ISBN |
1-280-46840-8
9786610468409 0-470-03723-7 0-470-03722-9 |
| Formato | Materiale a stampa |
| Livello bibliografico | Monografia |
| Lingua di pubblicazione | eng |
| Nota di contenuto |
The history of computers in pharmaceutical research and development: a narrative / Donald B. Boyd and Max M. Marsh -- Computers as data analysis and data management tools in preclinical development / Weiyong Li and Kenneth Banks -- Statistical modeling in pharmaceutical research and development / Andrea de Gaetano ... [et al.] -- Drug discovery from historic herbal texts / Eric J. Buenz -- Contextualizing the impact of bioinformatics on preclinical drug and vaccine discovery / Darren R. Flower -- Systems approaches for pharmaceutical research and development / Sean Ekins and Craig Giroux -- Information management-biodata in life sciences / Richard K. Scott and Anthony Parsons -- Chemoinformatics techniques for processing chemical structure databases / Valerie J. Gillet and Peter Willett -- Electronic laboratory notebooks / Alfred Nehme and Robert A. Scoffin -- Strategies for using information effectively in early-stage drug discovery / David J. Wild -- Improving the pharmaceutical R&D process: how simulation can support management decision making / Andrew Chadwick ... [et al.] --
Computers and protein crystallography / David J. Edwards and Roderick E. Hubbard -- Computers, cheminformatics, and the medicinal chemist / Weifan Zheng and Michael Jones -- The challenges of making useful protein-ligand free energy predictions for drug discovery / Jun Shimada -- Computer algorithms for selecting molecule libraries for synthesis / Konstantin V. Balakin, Nikolay P. Savchuk, and Alex Kiselyov -- Success stories of computer-aided design / Hugo Kubinyi -- Pharmaceutical research and development productivity: can software help? / Christophe Lambert and S. Stanley Young -- Computer methods for predicting drug metabolism / Sean Ekins -- Computers in toxicology and risk assessment / John C. Dearden -- Computational modeling of drug disposition / Cheng Chang and Peter W. Swaan -- Computer simulations in pharmacokinetics and pharmacodynamics: rediscovering systems physiology in the 21st century / Paolo Vicini -- Predictive models for better decisions from understanding physiology to optimizing trial design / James R. Bosley, Jr -- Making pharmaceutical development more efficient / Michael Rosenberg and Richard Farris -- Use of interactive software in medical decision making / Renée J. Goldberg Arnold -- Clinical data collection and management / Mazen Abdellatif -- Regulation of computer systems / Sandy Weinberg -- A new paradigm for analyzing adverse drug events / Ana Szarfman, Jonathan G. Levine and Joseph M. Tonning -- Computers in pharmaceutical formulation / Raymond C. Rowe and Elizabeth A. Colbourn -- Legal protection of innovative uses of computers in R&D / Robert Harrison -- The ethics of computing in pharmaceutical research / Matthew K. McGowan and Richard J. McGowan -- The UltraLink: an expert system for contextual hyperlinking in knowledge management / Martin Romacker ... [et al.] -- Powerful, predictive and pervasive: the future of computers in the pharmaceutical industry / Nick Davies, Heather Ahlborn, Stuart Henderson. |
| Record Nr. | UNINA-9910830560303321 |
| Hoboken, N.J., : Wiley-Interscience, c2006 | ||
| Materiale a stampa | ||
| Lo trovi qui: Univ. Federico II | ||
| ||
Computer applications in pharmaceutical research and development / / [edited by] Sean Ekins
| Computer applications in pharmaceutical research and development / / [edited by] Sean Ekins |
| Pubbl/distr/stampa | Hoboken, N.J., : Wiley-Interscience, c2006 |
| Descrizione fisica | 1 online resource (840 p.) |
| Disciplina | 615/.10285 |
| Altri autori (Persone) | EkinsSean |
| Collana | Wiley series in drug discovery and development |
| Soggetto topico |
Pharmacy - Data processing
Pharmacology - Data processing Pharmaceutical industry - Data processing |
| ISBN |
1-280-46840-8
9786610468409 0-470-03723-7 0-470-03722-9 |
| Formato | Materiale a stampa |
| Livello bibliografico | Monografia |
| Lingua di pubblicazione | eng |
| Nota di contenuto |
The history of computers in pharmaceutical research and development: a narrative / Donald B. Boyd and Max M. Marsh -- Computers as data analysis and data management tools in preclinical development / Weiyong Li and Kenneth Banks -- Statistical modeling in pharmaceutical research and development / Andrea de Gaetano ... [et al.] -- Drug discovery from historic herbal texts / Eric J. Buenz -- Contextualizing the impact of bioinformatics on preclinical drug and vaccine discovery / Darren R. Flower -- Systems approaches for pharmaceutical research and development / Sean Ekins and Craig Giroux -- Information management-biodata in life sciences / Richard K. Scott and Anthony Parsons -- Chemoinformatics techniques for processing chemical structure databases / Valerie J. Gillet and Peter Willett -- Electronic laboratory notebooks / Alfred Nehme and Robert A. Scoffin -- Strategies for using information effectively in early-stage drug discovery / David J. Wild -- Improving the pharmaceutical R&D process: how simulation can support management decision making / Andrew Chadwick ... [et al.] --
Computers and protein crystallography / David J. Edwards and Roderick E. Hubbard -- Computers, cheminformatics, and the medicinal chemist / Weifan Zheng and Michael Jones -- The challenges of making useful protein-ligand free energy predictions for drug discovery / Jun Shimada -- Computer algorithms for selecting molecule libraries for synthesis / Konstantin V. Balakin, Nikolay P. Savchuk, and Alex Kiselyov -- Success stories of computer-aided design / Hugo Kubinyi -- Pharmaceutical research and development productivity: can software help? / Christophe Lambert and S. Stanley Young -- Computer methods for predicting drug metabolism / Sean Ekins -- Computers in toxicology and risk assessment / John C. Dearden -- Computational modeling of drug disposition / Cheng Chang and Peter W. Swaan -- Computer simulations in pharmacokinetics and pharmacodynamics: rediscovering systems physiology in the 21st century / Paolo Vicini -- Predictive models for better decisions from understanding physiology to optimizing trial design / James R. Bosley, Jr -- Making pharmaceutical development more efficient / Michael Rosenberg and Richard Farris -- Use of interactive software in medical decision making / Renee J. Goldberg Arnold -- Clinical data collection and management / Mazen Abdellatif -- Regulation of computer systems / Sandy Weinberg -- A new paradigm for analyzing adverse drug events / Ana Szarfman, Jonathan G. Levine and Joseph M. Tonning -- Computers in pharmaceutical formulation / Raymond C. Rowe and Elizabeth A. Colbourn -- Legal protection of innovative uses of computers in R&D / Robert Harrison -- The ethics of computing in pharmaceutical research / Matthew K. McGowan and Richard J. McGowan -- The UltraLink: an expert system for contextual hyperlinking in knowledge management / Martin Romacker ... [et al.] -- Powerful, predictive and pervasive: the future of computers in the pharmaceutical industry / Nick Davies, Heather Ahlborn, Stuart Henderson. |
| Record Nr. | UNINA-9910877491303321 |
| Hoboken, N.J., : Wiley-Interscience, c2006 | ||
| 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 |
| 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 |
| 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-9910829396503321 |
| New York, : Informa Healthcare, c2010 | ||
| Materiale a stampa | ||
| Lo trovi qui: Univ. Federico II | ||
| ||
