Vastek Group

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

Computer System Validation

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