The Project Management team at CAID Automation is driven by the following goals:
Keep the project on schedule and on budget
Maintain the highest level of integrity
Ensure that the Customer is always informed about the real status of the project
Always looking at a situation from the Customer’s point of view
Significantly mitigate all potential technical and financial risks
Our Project Managers have years of experience in managing multi-million capital equipment projects and apply strict process steps to ensure that the equipment meets not only our rigorous quality standards, but also our Customer’s specifications.
As your automation solutions provider, we are intimate with the developed system. We are best able to document the system and develop a comprehensive validation plan to ensure all critical product attributes are consistently met.
With years of experience working with Fortune 500 companies in the Healthcare, Pharmaceutical, Medical Diagnostics and Aerospace and Defense sectors, we have developed the knowledge and expertise to provide a rigorous and comprehensive, fully-traceable validation package for your automated manufacturing solution. The validation protocols we execute are based on the GAMP guidelines as outlined by ISPE, our validation experience and the customer’s method for validation.
The validation protocols include consideration of:
Standard Operating Procedures (SOPs)
Quality and Project Plan
Product critical-to-quality attributes assessment and rationale
Product and/or process risk assessment
System Impact Assessment
Component Criticality Assessment
User Requirements Specification
Hardware Design Specification
Software Design Specification
Factory Acceptance Tests and Site Acceptance Tests
Installation, Operational, and Performance Qualification