LEADER 05586nam 22006854a 450 001 9910144386003321 005 20170815113543.0 010 $a1-282-34277-0 010 $a9786612342776 010 $a0-470-72182-0 010 $a0-470-72183-9 035 $a(CKB)1000000000578984 035 $a(EBL)406498 035 $a(OCoLC)476225870 035 $a(SSID)ssj0000181332 035 $a(PQKBManifestationID)11172217 035 $a(PQKBTitleCode)TC0000181332 035 $a(PQKBWorkID)10158874 035 $a(PQKB)10371342 035 $a(MiAaPQ)EBC406498 035 $a(EXLCZ)991000000000578984 100 $a20080619d2008 uy 0 101 0 $aeng 135 $aur|n|---||||| 181 $ctxt 182 $cc 183 $acr 200 10$aInternational IT regulations and compliance$b[electronic resource] $equality standards in the pharmaceutical and regulated industries /$fSiri H. Segalstad 210 $aChichester, West Sussex, United Kingdom $cWiley$d2008 215 $a1 online resource (340 p.) 300 $aDescription based upon print version of record. 311 $a0-470-69947-7 311 $a0-470-75882-1 320 $aIncludes bibliographical references and index. 327 $aInternational IT Regulations and Compliance; Contents; Preface and Acknowledgements; 1 Quality Standards; 1.1 What Quality Is; 1.2 Mandatory and Voluntary Standards; 1.3 Pharmaceutical Industry Regulations; 1.4 US GxP Regulations; 1.5 European GxP Regulations; 1.6 Other GxP Regulations; 1.7 Good Manufacturing Practice; 1.8 Good Laboratory Practice; 1.9 Good Clinical Practice; 1.10 Medical Device Standards; 1.11 IT Systems in the GxP and Medical Device Regulations; 1.12 GAMP; 1.13 Mandatory Quality Standards in Other Industries; 1.14 Legal Issues; 1.15 The ISO; 1.16 The ASTM; 1.17 The IEEE 327 $a1.18 TasksReferences; 2 Regulatory Requirements for IT Systems; 2.1 Introduction; 2.2 US Requirements; 2.3 EU Requirements; 2.4 21 CFR Part 11; 2.5 The 'Part 11 Project'; 2.6 EU GMP Annex 11; 2.7 The PIC Document PI 011 Recommendation on Computerized Systems in Regulated 'GxP' Environments; 2.8 GAMP; 2.9 The ISO 9000 Series; 2.10 A Comparison between the Standards; 2.11 Conclusion; 2.12 Tasks; References; 3 IT Security; 3.1 Introduction; 3.2 Continuous Connections - Wireless Networks; 3.3 Threats; 3.4 The Security Policy; 3.5 Tasks; References; 4 Quality Management Systems 327 $a4.1 An Introduction to QMS4.2 Definitions; 4.3 Principles for Quality Management; 4.4 Quality Management System Levels; 4.5 Creating a QMS; 4.6 Roles and Responsibilities; 4.7 Work Processes; 4.8 Controlled Documents; 4.9 The Quality Policy; 4.10 The Quality Manual; 4.11 Standard Operating Procedures; 4.12 The Art of Writing an SOP; 4.13 Tasks; References; 5 IT Integrated in the QMS in the User Organization; 5.1 Introduction; 5.2 How to Integrate IT Systems in the QMS; 5.3 Generic Standard Operating Procedures; 5.4 Procedures for Each System; 5.5 Tasks; References 327 $a6 IT Integrated in the Supplier's QMS6.1 Introduction; 6.2 Which Standards Should Be Used?; 6.3 The Quality Management System; 6.4 System Development Models; 6.5 Documents for Software Development; 6.6 The Customer-Supplier Relationship; 6.7 Tasks; References; 7 Organization for an IT System; 7.1 Introduction; 7.2 Roles and Responsibilities for a Live System; 7.3 Groups in the IT System Organization; 7.4 Roles and Responsibilities for an IT Validation Project; 7.5 Outsourcing; 7.6 The Service Level Agreement for Outsourcing; 7.7 Consultants; References 327 $a8 The Legal Implications of an IT System8.1 Introduction; 8.2 Pharmaceutical Regulations; 8.3 Financial Systems; 8.4 Patent Systems; 8.5 Human Resources Systems; 8.6 Healthcare Systems; 8.7 Systems for Legal Information; Reference; 9 Advanced Quality Management Systems; 9.1 Introduction; 9.2 The Live QMS is a Good QMS; 9.3 Changes; 9.4 How to Keep the QMS Updated; 9.5 Training and Understanding; 9.6 How to use a QMS Effectively as a Tool in the Organization - Not as a Straightjacket; 9.7 Tasks; References; 10 Audits; 10.1 Introduction; 10.2 The ISO 9000 Series; 10.3 TickIT; 10.4 Why Audit? 327 $a10.5 Audit in a Risk-Based Environment 330 $aStandards, technologies, and requirements for computer validation have changed dramatically in recent years, and so have the interpretation of the standards and the understanding of the processes involved. International IT Regulations and Compliance brings together current thinking on the implementation of standards and regulations in relation to IT for a wide variety of industries. The book provides professionals in pharmaceutical and semiconductor industries with an updated overview of requirements for handling IT systems according to various Quality Standards and how to ?translate? these re 606 $aPharmaceutical technology$xStandards 606 $aPharmaceutical industry$xStandards 606 $aPharmaceutical industry$xQuality control 606 $aDrugs$xStandards 608 $aElectronic books. 615 0$aPharmaceutical technology$xStandards. 615 0$aPharmaceutical industry$xStandards. 615 0$aPharmaceutical industry$xQuality control. 615 0$aDrugs$xStandards. 676 $a615 676 $a615.19 700 $aSegalstad$b Siri H$0984317 801 0$bMiAaPQ 801 1$bMiAaPQ 801 2$bMiAaPQ 906 $aBOOK 912 $a9910144386003321 996 $aInternational IT regulations and compliance$92248137 997 $aUNINA