Week 1 – Software Categories, Life Cycle Phases, and Operational Activities

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

Week 2 – 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

Week 3 – Science Based Quality Risk Management and Validation Planning

• 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

Week 4 – Identify Regulated Records and Signatures, and Impact Assessment of Electronic Records

• HPLC System
• Chromatography Data System (CDS)
• GxP Records and Signatures Required by 21 CFR Part 11
• 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

Week 5 – 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

Week 6 – 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)

Week 7 – 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

Week 8 – 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

Week 9 & 10

Complete an End of Module Assignment

Prepare a report to identify different types of computerized systems and explain how from data-flow analysis potential source of undesired events or where record integrity could be compromised? Then specify an electronic record for one system and the main categories of controls to maintain its integrity and compliance to 21 CFR Part 11 and the signatures required by 21 CFR Part 211, 21 CFR Part 820 and ICH Q7.

Complete the Following Activities & Workshops

You will produce a number of deliverables during the course including:

• Determine the end user supplier activities during the lifecycle of a computerized system
• Identify where you would use risk based decision making throughout the lifecycle of a computerized system
• Prepare a Configuration Management Process Flow Diagram and identify where to use Change Control
• Define the content of typical logs and accompanying records for both incident Management and corrective and preventive action (CAPA)
• Determine suitable risk controls when assessing electronic records and electronic signatures.