Collaborative Case Management: Improving Service Delivery Through
Transcript of Collaborative Case Management: Improving Service Delivery Through
CONTENTS
List of TablesList of FiguresPreface
1 Introduction 1
2 Infrastructure Lifecycle ApproachRecommendation and ConceptualizationDesignDesign ReviewsDevelopment and IntegrationImplementationRelease for UseOperational LifeRetirementRetaining Project and Qualification-Related DeliverablesChapter 2 Summary
3 Infrastructure Qualification OverviewWhat is Infrastructure?What is Infrastructure Qualification?Why Qualify the Computer Infrastructure?Introduction to the Infrastructure Qualification ProcessAll Together
4 FDA EnforcementIntroductionFDA Computer Systems EnforcementGanes Chemicals (483 — 1999)Eli Lilly & Company (483 — 2001)
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Pharmacia Corporation (483 — 2000 and Warning Letter — 2001)Novartis Pharma GmbH (483 — 2002)Skele Tech (483 — 2003)Company Unknown (483 — 20904)Company Unknown (Warning Letter — 2004)International Pharm & Biotech Labs (EIR — June 2003)
5 Regulatory RequirementsIntroductionPotential Regulatory ConsequencesUS FDA Regulatory RequirementsEU Regulatory Guidance
6 21 CFR Part 11IntroductionLAN/WANServer Hardware and Service ComponentsSystem-level Software
7 Procedural Controls
8 Computer Infrastructure SecurityPhysical SecurityNetwork SecurityOther Key Security Elements
OSI Model Security ServicesAuthentication
Protection of Records and Audit TrailsProtection of RecordsAudit Trails
9 Infrastructure Qualification PlanningIntroductionQualification Project PlanProject Schedule
10 Qualification TestingIntroductionQualification Testing Lifecycle
Test PlanProtocolSummary (Analysis) Report
CommissioningSample Qualification Testing/Commissioning Test Cases
System-level SoftwareApplication ServersService ComponentsLAN/WAN
Infrastructure Qualification in the FDA Regulated Industryiv
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Miscellaneous EquipmentNetwork Centers
11 Qualification Testing System-level SoftwareIntroductionServer and Controllers Operating Systems
Qualification Testing Practices for Operating SystemsPart 11 Areas of Interest
Network Operating SystemsQualification Testing Practices for Operating SystemsQualification Testing Practices for FirmwarePart 11 Areas of Interest
Security, Diagnostic and Monitoring ToolsQualification Testing Practices for Standard Software PackagesPart 11 Areas of Interest
Desktop ImagesScripts
Qualification Testing Practices for ScriptsPart 11 Areas of Interest
File and Database ManagementMiddleware
Part 11 Areas of Interest
12 Qualification Testing Application Servers and Service ComponentsInstallation QualificationOperational Qualification
13 Qualification Testing LAN DevicesSwitchRouterQualification of Other LAN Devices
HubGatewaysRepeatersBridgesBrouter
14 Qualification Testing WAN DevicesExternal RouterWAN LinksFirewallVPN SwitchesLoad Balancing DevicesIntrusion Detection Devices
15 Qualification Testing WAN/LAN System
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16 Qualification Testing the Storage Area NetworksIntroductionQualification StrategyPart 11
17 Qualification Wireless ServicesWLAN Devices
Access PointVPN ServerLAN Switch
WLAN System Qualification
18 Qualification Testing Network CentersIntroductionQualification TestingInstallation QualificationOperational Qualification
19 Qualification Testing Database ManagerIntroductionDatabase Server — Single or ClusterDatabase Server SoftwareCritical Database Server IssuesPart 11 ConsiderationsQualification Testing
20 Change ManagementIntroductionType of ChangeChange Management ProcessEmergency ChangesPart 11 and Infrastructure Related Change
21 Training
22 Remediation ProjectIntroductionInfrastructure EvaluationCorrective Action Planning
InterpretationImpact AssessmentTrainingSuppliers Qualification Program
RemediationRemediation Project Report
23 Maintaining the State of QualificationIntroduction
Infrastructure Qualification in the FDA Regulated Industryvi
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