Electronic Record Keeping: Achieving and Maintaining Compliance with 21 Cfr Part 11 and 45 Cfr Parts 160, 162, and 164 (Hardcover)

ELECTRONIC RECORD KEEPING: THE BIG PICTURERegulatory EvolutionThe Electronic RevolutionCompliance RequirementsGeneral Basis for Electronic RecordsSecurity, Data Transfer, Operation Checks, Archiving, and Audit TrailsTHE REGULATIONS: NOT JUST WHAT THEY SAY, BUT WHAT THEY MEAN21 CFR Part 11 Electronic Records; Electronic Signatures and 45 CFR Parts 160, 162, and 164 Health Insurance Reform: Security StandardsGOING ELECTRONIC: WHAT YOU NEED TO KNOW AND DOSoftware Development and Use: From Then Till NowThe COTS Software Development Life CyclePurchasing COTS SoftwareDeveloper and User ValidationOperating EnvironmentsIQ/OQ/PQ and CSVRetrospective ValidationDOCUMENTATION AND TRAINING The Validation Packet Validation DocumentsSystem Support DocumentsAdditional RecordsTrainingSECURITY, ACCOUNTABILITY, AND CHANGE MANAGEMENTManaging the System Security and the People FactorOngoing Communication Managing Passwords: A KeychainBiometric KeychainsChange ManagementAUDITING ELECTRONIC RECORD KEEPING SYSTEMSEstablishing an Audit Function Establishing the Scope of the Audit and preparing to AuditReviewing Binding Regulations and DocumentationPlanning the AuditConducting the Actual Audit Evaluating and Reporting Results Keeping the Audit Function Vital Auditing and the Regulatory InspectionMOVING FORWARDComputer System Validation Committee Changing Company CulturesGap AnalysisComputer System InventoryRemaining VigilantFREQUENTLY ASKED QUESTIONS Binding RegulationsSoftware Vendors Computer System Validation Electronic Records Electronic Signatures and AccountabilitySecuritySystemsAudit Trails Staying Informed