Monitor Medical Drug’s effect to identify & evaluate unreported adverse reactions.

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
Real Life Case Studies

Real Life Case Studies

Projects modeled on select use cases with implementation of diverse technology concepts



All guided classes and courses are mandatorily followed by useful practical assignments

24x7 Expert Support

24x7 Expert Support

Every technical query is resolved on demand with readily available expert assistance

Instructor-led Sessions

Instructor-led Sessions

Technical session conducted under the guidance of qualified and certified educationists

Course Info

Course Start Date 01/30/2023
Estimated Duration 3/4 Weeks
Maximum Students 10
Levels Advanced

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