Apply GAMP 5 Best Practices to Your Next Validation Project

Over 80 PAGES of resources and information surrounding the GAMP 5 Best Practices!

GAMP® 5 provides pragmatic and practical industry guidance to achieve compliant computerized systems fit for intended use in an efficient and effective manner. The GAMP 5 Good Practice guide is a technical document that describes a flexible risk-based approach to compliant GxP regulated computerized systems, based on scalable specification and verification. 

Montrium has developed an introductory guide to the GAMP 5 Guidance, providing over 80 slides of information on GAMP 5 and how to apply it to your next validation project.

Slidedeck contains:

  • Introduction to GAMP5
  • Differences between GAMP4 and GAMP5
  • How to use GAMP5 effectively
  • What the regulations say
  • High-level overview of the key concepts of GAMP5
    • Quality Management
    • V Model
    • Lifecycle Phases
    • System Categories
    • Documentation
    • Required Procedures
    • Supplier Management