Projects compliant to
GAMP | VALIDATION
Projects compliant to
Good Automation Practices
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
INDUSTRIAL AUTOMATION
Computerized System Validation
Validation of Automation and Computerized System is more and more a critical in view of the new regulations by the international agencies, and it is a must to fully comply with the regulatory standard and the user requirements.
IASTECH provides services for validation of computerized systems, based on the interpretation of current GMP (Good Manufacturing Practice) standard and the required documentation level. IASTECH assists customers to develop the Validation Master Plan, IQ, OQ, PQ and the Validation execution, in compliance with requirements of official agencies (ANVISA, FDA, EMEA).
