Planning for
Your Production Success
We help you develop CQV strategies that align with your internal procedures, and requirements with an emphasis on a risk-based approach. From commissioning and qualification of equipment to final validation of your processes, our services guarantee the operational success of your facility, utilities and manufacturing systems. Our experience includes commissioning, qualification and validation of retrofitted, new, off the shelf or fully custom systems. We adapt our approach to every project, bringing our deep expertise to your unique system.
Commissioning, Qualification & Validation Solutions
CQV Strategic Development
We have extensive experience in developing CQV strategies for small and large scale projects. As part of our process, we engage all project stakeholders including quality, engineering, maintenance, and end users to develop a unified strategy. Our risk-based CQV methodology focuses on the input of our Subject Matter Experts to deliver quality results that will ensure operational readiness of your facilities. Our distinguished experts will work together with your team to develop a CQV strategy that fits your projects, site and business needs.
System Startup & Commissioning
Our commissioning engineers place a heavy emphasis on the startup and commissioning stage in order to properly ensure a successful qualification phase. We test systems rigorously while using the startup/shakedown phase to run through protocol test methods, iron out all automation issues and verbiage to ensure smooth execution during the validation stage. This approach has been proven to significantly reduce the number of non-conformances encountered in the qualification and validation stages. During commissioning, we will also work to uncover potential operational system improvements and optimizations for the end users. Join our list of satisfied clients who have worked with us on their CQV projects.
Design Qualification and Installation & Operational Qualification
We have written and executed hundreds of commissioning and qualification protocols, including all stages from design qualification to process qualification. All of our process engineers are cross-trained as CQV engineers, which allows for a flexible workforce and systems designed with ease of testing in mind. In many cases, our qualifications have included upgrades, modifications, and retrofitting of existing systems, which often requires a high degree of customization. Turn to the experts to prepare your CQV documents, including quality plans, reports, procedures, SOPs, criticality and risk assessments.
Computer Systems Validation
With regulatory bodies pushing pharmaceutical and biopharmaceutical manufacturers to comply with increasingly stricter data integrity requirements, Cheme offers you a solution. Our validation engineers continue to meet the growing needs for computer systems validation (CSV) by defining validation strategies, as well as developing and executing CSV test scripts. Cheme has successfully validated custom computerized automation systems which meet these strict regulatory mandates, covering everything from a simple Allen-Bradley PLC to a complex DCS like Emerson DeltaV. Trust our experts in CSV to keep your systems up to date and compliant.
Cleaning Validation
Cheme works with clients to design and execute cleaning validation on new equipment and tanks for various drug product soils. We support clients in designing and executing thorough sampling procedures for cleaning validation to ensure selected cleaning methods are adequate and robust. Our team works with technologists, operators, and labs to ensure all personnel are fully trained on new and existing cleaning requirements. If you’re not quite there, Cheme has experience in supporting mock trials and preliminary cleaning baselining. Our cleaning validation experts perform bridging studies to document and transition from cleaning validation to routine cleaning monitoring. Ensure your system’s hygienic systems are validated and compliant with help from our cleaning validation specialists.
Process Validation
Our team of engineering experts understand that process validation is a critical step in the commercialization of a project. Cheme develops process validation plans and execution strategies. As we grow our team of process engineers, we are constantly improving and maintaining our relevant knowledge and best practices to handle the delicate task of validating our client’s GMP processes. When you need to validate your most critical processes, work with the experts at Cheme.
SU Extractables & Leachable Studies
Many manufacturing facilities continue to move towards single-use platforms, and extractables and leachables (E&L) studies become critical in the validation of these systems. Cheme has experience in planning and developing E&L studies, and has developed relationships with laboratories who execute and prepare our clients’ results. We review vendor technical data in detail to determine final product impact and patient safety concern thresholds. Ensure the performance of your single-use systems with expert applications of the latest E&L validation practices.
Industry-Leading
CQV Services
Industry-Leading
CQV Services
Cheme provides CQV services to companies in highly regulated industries. We offer a science and risk-based approach to CQV from our earliest engineering design phases. Quality is a mindset, and not something we merely comply with at the end. We believe quality is built into a project from the very beginning. Let us help you identify your needs to comply with regulatory requirements.
Turn to Our
System CQV Experts
Turn to Our
System CQV Experts
To properly qualify a system, our engineers bring their specialized skill sets and industry knowledge to deliver the best-in-class CQV strategies. We take ownership of scope and timelines, and we take great pride in the work that we do and the results that we deliver. Our team continues to build strong, enduring relationships with our customers, as evidenced by our retention and growth.
Project Success
