This training focuses on developing and implementing regulated computer systems with an appropriate level of documented evidence to satisfy FDA expectations. The core elements of computer validation program will be emphasized.

Topics to be discussed include:

  • SDLC (System Development Life Cycle) Process
  • Computer System Validation fundamentals
  • Verification vs Validation
  • The Validation Regulations
  • Overview of 21 CFR Part 11
  • Review of Part 11 implication in regulations and guidance
  • 21 CFR Part 211
  • 21 CFR Part 820
  • Overview of GAMP 5 (Good Automated Manufacturing Practices)
  • Overview of IEC 62304 – Medical Device Software Lifecycle Process
  • URS, FRS, Design Specification
  • Risk Assessment in Computer System Validation
  • Validation Plans and Master Validation Plans
  • Design Qualification (DQ)
  • Installation Qualification (IQ)
  • Operational Qualification (OQ) and Performance Qualification (PQ)
  • Requirements Traceability Matrix
  • Validation Summary Report
  • SOP’s for system operation and maintenance

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