Automation Validation

Home / Automation Validation

Avanceon has a long standing history of providing validation services for both the projects we develop and those that we do not. Our expertise in Computer System Validation allows to do more than just “execute the protocol.” We add value.
 
We have significant experience with projects affected by federal guidelines and regulations and plan, develop, and execute validation alongside many industry-leading regulated clients. We leverage our internal Standards & Tools throughout the project lifecycle to provide consistent, high quality documentation deliverables.
 
As a process, we utilize a GAMP5 risk-based lifecycle approach whenever possible, resulting in more efficient validation processes, superior system functionality, and greater user satisfaction.
 
At Avanceon, we understand the FDA’s approach to compliance and will enhance your systems, plant, and equipment to meet regulatory expectations. Whether a project involves consulting or validation services for a single piece of equipment, a process solution, or an entire facility, we have the knowledge and experience to provide the required assistance.
 

Validation Rock Star Moment
It takes more than engineering acumen to become a Rock Star and trusted advisor. For example, our validation depth recently helped us take major pressure off one of our customers. They faced overwhelming regulatory documentation requirements for a new product – requirements that were so complex and confusing they would significantly delay product rollout – perhaps even prevent it entirely. But our process and control experience allowed us to clearly explain the validation requirements, organize the necessary information, deliver the components we could prepare for them, and work with them on the elements they needed to do themselves. The regulatory agency accepted their proposal, and the product came to market successfully.