compliance-services
quote

CG surprised us with better than expected improvements. These guys are experts and they’re great to work with..

Robin Blankenbaker, Head of Quality, Gore Medical

HOW CAN WE HELP YOU?
COMMISSIONING, QUALIFICATION, AND VALIDATION (CQV)
One of our specialty areas, our network of expert resources have experience validating, implementing, and supporting day-to-day technical and functional needs for over 500 off-the-shelf customized IT software systems and applications. We offer expertise in manufacturing, process validation, equipment validation, and computer system validation using a lean, risk-based approach. From continuous process improvements to implementations, integrations, and overall maintenance, our team of talent can provide immediate support help to best fit your project and organizational needs. If you are bringing in new equipment, expanding or building a new facility, upgrading a system, or you are dealing with an inspection observation from a regulatory agency – we can lead the entire validation project, or we can augment your team with validation expertise. Our experience working with equipment vendors and 3rd party suppliers expedites the process and ensures compliance.
QUALITY ASSURANCE & MANUFACTURING AUTOMATION VALIDATION
We offer expertise in the validation of manufacturing automation systems, including Delta V, PLCs, Scada and other systems that are subject to regulatory requirements. Our relationships with external vendors of PLC and Scada systems enable our team to expedite the validation process. Whether you are having issues with your vendors or installations of PLC and Scada systems, we offer the experience of implementing end-to-end solutions.
QMS SUPPORT
We offer resources to develop QMS policies and procedures. Whether you are developing your own QMS, struggling to streamline your processes to adhere to new guidance, or need to respond to a regulatory observation, our experienced professionals can develop new or updated SOPs for managing your quality function. We ensure you have all of the required controls within your system.
AUDIT (SUPPLIER/INTERNAL)
Our staffing resources include auditors that can assist with supplier audits, leveraging relationships we have with suppliers to streamline the process. We also offer mock audit services to test your processes and ensure compliance. Whether you have a new facility getting initiated, or are acquiring a variety of new suppliers, we provide the ability to expand your audit capacity as needed.
IT EXPERTISE
We provide a variety of expert resources to assist you with expanding and enhancing your IT solutions. We provide developers, business analysts, and project managers with specialized skills to either run with new projects or expand your capacity to deliver solutions to the business.
Talk to our experts