Software Categories, Life Cycle Phases, and Operational Activities:

• Drivers for GAMPS
• Life Cycle Phases of Computerized Systems
• Computerized Systems in Regulated GxP Environments
• GAMP 5 Software Categories
• Operational Activities
• Handover
• Product and Process Understanding
• End User Activities

Record Anatomy and Data Flow Analysis

• Electronic Record Content, Structure and Context, and Record Anatomy
• Records and Signatures required by 21 CFR Part 211
• PLC Controlled Packaging Equipment
• Supervisory Control and Data Acquisition (SCADA)
• Data Flow Analysis
• Example Records and Signatures Required by ICH Q7

Science Based Quality Risk Management, Validation Planning, and Categorization of Laboratory Computerized Systems

• Supplier Activities
• Validation Planning
• Science Based Quality Risk Management
• Risk Management
Considerations Generic Hazards • Requirements Traceability Matrix (RTM)
• Efficiency Improvements (Continuous Improvements)
• Categorization of Laboratory Computerized Systems

Identify Regulated Records and Signatures, and Impact Assessment of Electronic Records

• HPLC System
• Chromatography Data System (CDS)
• GxP Records and Signatures Required by 11 CFR Part 820
• Prerequisites for Good Electronic Records Management
• Laboratory Information Management System (LIMS)
• Identify Regulated Records and Signatures
• Electronic Production Records (EPR)
• Impact Assessment of Electronic Records
• Spreadsheets

Specification and Verification, Scalable Validation Deliverables and Configuration Management

• Organizational Change
• Outsourced IS/IT Environment
• IT Compliance
• Development versus Implementation Life Cycle
• ASTM E 2500 – 07
• Testing Documentation Structure & Verification Terminology
• Scalable Validation Deliverables
• Patch and Update Management
• Operational Change and Configuration Management
• Repair Activity
• Periodic Review
• Backup and Restore

Good Electronic Records Management Transactions, and Audit Trails

• Good Electronic Records Management Transactions
• Audit Trails
• AutoCAD Used For Managing Pack Drawings
• Building Management Systems (BMS)
• FDA Predicate Rule 21 CFR Part 211 – Subparts D and J
• FDA 21 CFR Part 11 – ‘Electronic Records; Electronic Signatures’ (ERES)

Electronic Data Archiving, Business Continuity Management, and System backup, Archival, and Disaster Recovery

• Electronic Data Archiving Part
• Typical Tasks Supporting Validation (B)
• Security Management
• Business Continuity Management
• System Retirement Decommissioning and Disposal
• Copies of Records

Controls to Maintain Electronic Record Integrity, and Risk Controls for Electronic Signatures

• Complying with 21 CFR Part 11 ERES – Types of Controls Required
• Complying with 21 CFR Part 11 – Key Areas for Guidance
• Batch Record System
• Enterprise Resource Planning (ERP) Systems
• Controls to Maintain Electronic Record Integrity
• Risk Controls for Electronic Records
• Risk Controls for Electronic Signatures
• User ERES Responsibilities
• Supplier ERES Responsibilities