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[null,"1.","Record Nr.",null,"UNINA9910792350003321"]
[null,null,"Titolo",null,"Pharmaceutical computer systems validation : quality assurance, risk management and regulatory compliance / / edited by Guy Wingate"]
[null,null,"Pubbl/distr/stampa",null,"New York : , : Informa Healthcare, , 2010"]
[null,null,"ISBN",null,"0-429-13762-1"]
[{"$nulls":4},"1-282-56102-2"]
[{"$nulls":4},"9786612561023"]
[{"$nulls":4},"1-4200-8895-5"]
[null,null,"Edizione",null,"[2nd ed.]"]
[null,null,"Descrizione fisica",null,"1 online resource (773 p.)"]
[null,null,"Disciplina",null,"615.1068/4"]
[{"$nulls":4},"615.10684"]
[null,null,"Soggetti",null,"Pharmaceutical industry - Management"]
[{"$nulls":4},"Pharmaceutical industry - Data processing"]
[{"$nulls":4},"Health facilities - Risk management"]
[{"$nulls":4},"Risk management - Data processing"]
[null,null,"Lingua di pubblicazione",null,"Inglese"]
[null,null,"Formato",null,"Materiale a stampa"]
[null,null,null,"Livello bibliografico","Monografia"]
[null,null,null,"Note generali","Rev. ed. of: Computer systems validation / editor, Guy Wingate. Boca Raton, Fla. : Interpharm/CRC, c2004."]
[null,null,null,"Nota di bibliografia","Includes bibliographical references and index."]
[null,null,"Nota di contenuto",null,"Front Cover; Foreword to the Second Edition; Foreword to the First Edition; Preface; Contributor Biographies; Abbreviations; Contents; Chapter 1. Introduction; Chapter 2. Organization and Management; Chapter 3. Supporting Processes; Chapter 4. Prospective Verification and Validation; Chapter 5. Project Initiation and Compliance Determination; Chapter 6. Requirements Capture and Supplier (Vendor)Selection; Chapter 7. Design and Development; Chapter 8. Coding, Configuration, and Build; Chapter 9. Development Testing; Chapter 10. User Qualification and Authorization to Use"]
[{"$nulls":4},"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"]
[{"$nulls":4},"Chapter 23. Case Study 5: Control and Monitoring InstrumentationChapter 24. Case Study 6: Process Control Systems; Chapter 25. Case Study 7: Manufacturing Execution Systems and Electronic Batch Records; Chapter 26. Case Study 8: Building Management Systems; Chapter 27. Case Study 9: Engineering Management Systems; Chapter 28. Case Study 10: Desktop Applications Including Spreadsheets; Chapter 29. Case Study 11: Databases; Chapter 30. Case Study 12: Electronic Document Management Systems; Chapter 31. Case Study 13: Enterprise Resource Planning Systems"]
[{"$nulls":4},"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"]
[null,null,null,"Sommario/riassunto","Thoroughly revised to include the latest industry developments, the Second Edition presents a comprehensive overview of computer validation and verification principles and how to put them into practice. To provide the current best practice and guidance on identifying and implementing improvements for computer systems, the text extensively reviews regulations of pharmaceuticals, healthcare products, blood processing, medical devices, clinical systems, and biotechnology. Ensuring that organizations transition smoothly to the new system, this guide explains how to implement the new GMP paradigm w"]
[null,"2.","Record Nr.",null,"UNINA9910484999303321"]
[null,null,"Titolo",null,"On the Move to Meaningful Internet Systems: OTM 2009 : Confederated International Conferences, CoopIS, DOA, IS, and ODBASE 2009, Vilamoura, Portugal, November 1-6, 2009, Proceedings, Part II / / edited by Robert Meersman, Tharam Dillon, Pilar Herrero"]
[null,null,"Pubbl/distr/stampa",null,"Berlin, Heidelberg : , : Springer Berlin Heidelberg : , : Imprint : Springer, , 2009"]
[null,null,"ISBN",null,"3-642-05151-0"]
[null,null,"Edizione",null,"[1st ed. 2009.]"]
[null,null,"Descrizione fisica",null,"1 online resource (XXVI, 481 p.)"]
[null,null,"Collana",null,"Information Systems and Applications, incl. Internet/Web, and HCI, , 2946-1642 ; ; 5871"]
[null,null,"Disciplina",null,"004.6"]
[null,null,"Soggetti",null,"Computer networks"]
[{"$nulls":4},"Data protection"]
[{"$nulls":4},"Computer science"]
[{"$nulls":4},"Database management"]
[{"$nulls":4},"Data mining"]
[{"$nulls":4},"Application software"]
[{"$nulls":4},"Computer Communication Networks"]
[{"$nulls":4},"Data and Information Security"]
[{"$nulls":4},"Theory of Computation"]
[{"$nulls":4},"Database Management"]
[{"$nulls":4},"Data Mining and Knowledge Discovery"]
[{"$nulls":4},"Computer and Information Systems Applications"]
[null,null,"Lingua di pubblicazione",null,"Inglese"]
[null,null,"Formato",null,"Materiale a stampa"]
[null,null,null,"Livello bibliografico","Monografia"]
[null,null,null,"Note generali","Selected conference papers."]
[null,null,null,"Nota di bibliografia","Includes bibliographical references and index."]
[null,null,"Nota di contenuto",null,"IS 2009 Keynote -- Cloud Computing: Virtual Clusters, Data Security, and Disaster Recovery -- ODBASE 2009 Keynote -- Surviving the Glut: The Management of Event Streams in Cyberphysical Systems -- International Symposium on Information Security (IS) International Conference 2009 -- IS 2009 – PC Co-chairs’ Message -- Information Systems Security -- Moving from Requirements to Design Confronting Security Issues: A Case Study -- A Synergy between Static and Dynamic Analysis for the Detection of Software Security Vulnerabilities -- N±?: Reflecting Local Risk Assessment in LoA -- Privacy and Authentication -- A Secure Mobile-Based Authentication System for e-Banking -- "]
[{"$nulls":4},"Client-Server Password Recovery -- Enhancing of a Password-Based Authentication Scheme Using Smart Cards -- Security Policies and Verification -- Model-Driven Configuration of SELinux Policies -- Towards a Usage Control Policy Specification with Petri Nets -- Verification of CERT Secure Coding Rules: Case Studies -- Ontologies, DataBases, and Applications of Semantics (ODBASE) International Conference 2009 -- ODBASE 2009 – PC Co-chairs’ Message -- Managing Ontologies -- Ontology and Schema Evolution in Data Integration: Review and Assessment -- Detecting Inconsistencies in the Gene Ontology Using Ontology Databases with Not-gadgets -- How to Write and Use the Ontology Requirements Specification Document -- Achieving Maturity: The State of Practice in Ontology Engineering in 2009 -- Using Ontologies -- Ontology-Driven Provenance Management in eScience: An Application in Parasite Research -- Ontology-Based Retrieval of Spatially Related Objects for Location Based Services -- Incremental Generation of Mappings in an Ontology-Based Data Access Context -- Event Processing -- The Design of Stream Database Engine in ConcurrentEnvironment -- “Same, Same but Different” A Survey on Duplicate Detection Methods for Situation Awareness -- Client-Side Event Processing for Personalized Web Advertisement -- Semantic Event Correlation Using Ontologies -- An Active Domain Node Architecture for the Semantic Web -- Dealing with Heterogeneity -- Merging Sets of Taxonomically Organized Data Using Concept Mappings under Uncertainty -- LinksB2N: Automatic Data Integration for the Semantic Web -- Learning Link-Based Naïve Bayes Classifiers from Ontology-Extended Distributed Data -- A Method and Tool for Fact Type Reuse in the DOGMA Ontology Framework -- Heterogeneity and Context in Semantic-Web-Enabled HCLS Systems -- XML-SIM: Structure and Content Semantic Similarity Detection Using Keys -- Partial Ontology Matching Using Instance Features -- Building Knowledge Bases -- DBpedia Live Extraction -- Semi-automatic Generation of a Patient Preoperative Knowledge-Base from a Legacy Clinical Database -- Exploring Wikipedia and DMoz as Knowledge Bases for Engineering a User Interests Hierarchy for Social Network Applications -- XML and XML Schema -- XML Schema Element Similarity Measures: A Schema Matching Context -- On the Performances of Checking XML Key and Functional Dependency Satisfactions."]
[null,null,null,"Sommario/riassunto","This two-volume set LNCS 5870/5871 constitutes the refereed proceedings of the four confederated international conferences on Cooperative Information Systems (CoopIS 2009), Distributed Objects and Applications (DOA 2009), Information Security (IS 2009), and Ontologies, Databases and Applications of Semantics (ODBASE 2009), held as OTM 2009 in Vilamoura, Portugal, in November 2009. The 83 revised full papers presented together with 4 keynote talks were carefully reviewed and selected from a total of 234 submissions. Corresponding to the four OTM 2009 main conferences CoopIS, DOA, IS, and ODBASE the papers are organized in topical sections on workflow; process models; ontology challenges; network complexity; modeling cooperation; information complexity; infrastructure; information; aspect-oriented approaches for distributed middleware; distributed algorithms and communication protocols; distributed infrastructures for cluster and Grid computing; object-based, component-based, resource-oriented, event-oriented, and service-oriented middleware; peer-to-peer and centralized infrastructures; performance analysis of distributed computing systems; reliability, fault tolerance, quality of service, and real time support; self* properties in distributed middleware; software engineering for distributed "]
[{"$nulls":4},"middleware systems; security and privacy in a connected world; ubiquitous and pervasive computing; information systems security; privacy and authentication; security policies and verification; managing ontologies; using ontologies; event processing; dealing with heterogeneity; building knowledge bases; and XML and XML schema."]