Validation
Hobvision has a very long standing history of providing validation services for the in house projects that we develop and for the projects we cater in various sectors such as pharma, cement, pulp & paper, Bio-medical, Oil & gas, steel. We have significant experience with projects effected 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 Hobvision, 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
Consistent documentation and compliance with the regulations and guidelines like cGMP, GAMP, USP Requirements, ISPE Engineering Baseline Guide. We create the conditions to make sure you experience a successful inspection of your system. Qualification of each project follows the ”V-model”, from URS to the final FAT/SAT which is carried out before the system is finally handed over to the customer, as shown below.