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PIC/S Computerized Systems

PIC/S GMP principles for computerized systems, system lifecycle and validation, access security, electronic data integrity, backup, business continuity, and maintaining system control.

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Course Content

Module 1: Introduction to Computerised Systems
  • 1. Computerized Systems in GMP
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  • 2. PIC/S Annex 11 Overview
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Module 2: System Lifecycle & Validation
  • 1. Computerized System Lifecycle
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  • 2. Computerized System Validation
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Module 3: User Access & Security
  • 1. Access Control
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  • 2. User Accountability & Security
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Module 4: Electronic Data & Data Integrity
  • 1. Electronic GMP Data
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  • 2. Audit Trails
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Module 5: Data Protection, Backup & Business Continuity
  • 1. Data Protection & Backup
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  • 2. Business Continuity
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Module 6: Maintaining System Control
  • 1. Change Control & Periodic Evaluation
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  • 2. System Incidents & Inspection Readiness
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Final Assessment
Complete all modules to unlock final exam
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