GAMP compliant projects

IASTECH develops projects in compliance with GAMP (Good Automated Manufacturing Practice) including:

• Deficiency analysis with regard to GAMP
• Preparation/customization of Document Templates (templates based on GDP - Good Documentation Practices) for URS - User Requirement Specification, FS -Functional Specification, SDS - Software Design Specification and SMDS - Software Module Design Specification
• Decision on Development Model
• Risk Analysis and Action Plan

 

Planning and Development X Tests Chart