ELECTRONIC RECORD KEEPING: THE BIG PICTURE -- Regulatory Evolution -- The Electronic Revolution -- Compliance Requirements -- General Basis for Electronic Records -- Security, Data Transfer, Operation Checks, Archiving, and Audit Trails -- THE REGULATIONS: NOT JUST WHAT THEY SAY, BUT WHAT THEY MEAN -- 21 CFR Part 11 Electronic Records; Electronic Signatures and 45 CFR Parts 160, 162, and 164 Health Insurance Reform: Security Standards -- GOING ELECTRONIC: WHAT YOU NEED TO KNOW AND DO -- Software Development and Use: From Then Till Now -- The COTS Software Development Life Cycle -- Purchasing COTS Software -- Developer and User Validation -- Operating Environments -- IQ/OQ/PQ and CSV -- Retrospective Validation -- DOCUMENTATION AND TRAINING -- The Validation Packet -- Validation Documents -- System Support Documents -- Additional Records -- Training -- SECURITY, ACCOUNTABILITY, AND CHANGE MANAGEMENT -- Managing the System -- Security and the People Factor -- Ongoing Communication -- Managing Passwords: A Keychain -- Biometric Keychains -- Change Management -- AUDITING ELECTRONIC RECORD KEEPING SYSTEMS -- Establishing an Audit Function -- Establishing the Scope of the Audit and preparing to Audit -- Reviewing Binding Regulations and Documentation -- Planning the Audit -- Conducting the Actual Audit -- Evaluating and Reporting Results -- Keeping the Audit Function Vital -- Auditing and the Regulatory Inspection -- MOVING FORWARD -- Computer System Validation Committee -- Changing Company Cultures -- Gap Analysis -- Computer System Inventory -- Remaining Vigilant -- FREQUENTLY ASKED QUESTIONS -- Binding Regulations -- Software Vendors -- Computer System Validation -- Electronic Records -- Electronic Signatures and Accountability -- Security -- Systems -- Audit Trails -- Staying Informed.