Computer System Validation Training

Course Available Online, Nationwide

In a digital world, an efficient and effective computer system forms the background of any successful company. This training course will equip you with the means to effectively identify necessary areas for improvement within the digital sphere of the company in question, develop and implement relevant improvements and, eventually, validate the system. Our industry experts offer validation services and offer this course nationwide – online and face-to-face.

It will include coverage of:

Regulatory Background

  • Validation Process
  • Supporting Procedures
  • SDLC Life Cycle
  • Preparation of Standard Procedures
  • Critical Parameter Assessment
  • GMP Criticality and Risk Analysis
  • Process Validation Methodology
  • Computerized System Validation
  • Preparation of Validation Plans
  • Preparation of Project and Quality Plans
  • Manufacturing Data Specification
  • URS Preparation
  • Supplier Audit and Evaluation
  • Qualification Protocol Preparation
  • Qualification Review and Reporting
  • System Access Security
  • Backup, Archiving, and Retrieval
  • System Operation and Management
  • Contingency/Recovery Planning
  • System Maintenance
  • Calibration
  • Periodic Review and Reporting
  • Decommissioning

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