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