With the introduction of ‘GAMP5 – A Risk-based approach to compliant GxP Computerised Systems’ by the ISPE. iAutomation can provide our clients with practical approach to the qualification and control of IT/Automation infrastructure.

Leveraging from the ISO, IEEE and ISA iAutomation has developed a comprehensive model used to assess the state of IT/Automation compliance. The IT/Automation compliance model shall identify and address any gaps within the clients system.

Our service is based upon the classic V-Shape model and team can assist with any or all of the following activities:

• Generation of User Requirement Specification (URS)
• Generation of Functional Design Specification (FDS)
• Generation of Hardware Design Specification (HDS)
• Generation of Software Design Specification (SDS)
• Software Module Testing
• System Risk Analysis
• SOP Development
• Change Control
• 21 CFR Part 11 Assessments

Benefits

• Significantly reduce validation costs
• Assure compliance with GAMP, cGMP

If you have any questions, or wish to contact us directly, please contact info@iautomation.ie