We provide a suite of validation services for GAMP applications used in pharmaceutical industries. We have built a reputation in the field of Control System (PLC) and Software validation. Our expertise in automation and information technology, equipment, processes and regulations makes us uniquely suited for developing and validating integrated manufacturing systems and hence provide you with a TOTAL SOLUTION.
We also take care of US FDA 21 CFR Part 11 related issues for total compliance. We have proven track record of clearing USFDA, UKMCA, and MCC etc.
We help you in developing a validation project plan to ensure that all validation requirements are considered up front. This is the most prudent way to commence a project as it will eliminate rework and will ensure that you are doing it right the first time. We prepare and implement installation qualification (IQ), operational qualification (OQ) and performance qualification (PQ) protocols to qualify the entire system, i.e., equipment, computer system and process. Our "systems" approach focuses on optimizing and uncovering deficiencies, which impact product quality as well as system performance and safety.
We can assist you in identifying technologies, evaluating vendors and developing functional requirements and specifications to meet your specific validation needs. We can work closely with in-house teams, system vendors and integrators during development, installation and commissioning phases. This approach will enable us to build validation into the project life cycle and also gather data at appropriate stages of the project to support validation requirements, which eliminates redundant testing.+ Read More