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 Commissioning, Qualification, and Validation (CQV) strategies for both small and large-scale projects. Our process involves engaging all project stakeholders, including quality, engineering, maintenance, and end users, to develop a unified strategy. Our risk-based CQV methodology leverages the expertise of our Subject Matter Experts to deliver high-quality results, ensuring the operational readiness of your facilities. Our distinguished experts collaborate closely with your team to develop a CQV strategy tailored to your project’s specific needs, site requirements, and business objectives.
Paperless Commissioning, Qualification and Validation (CQV)
At Cheme, we specialize in implementing paperless Commissioning, Qualification, and Validation (CQV) programs to save time and effort. Our digital solutions streamline documentation processes, reduce manual errors, and enhance data integrity. By transitioning to paperless systems, we help clients achieve faster project completion and improved regulatory compliance. Our team ensures seamless integration of digital tools, providing training and support to maximize efficiency. Trust Cheme to modernize your CQV programs with cutting-edge, paperless solutions
System Startup & Commissioning
Our commissioning engineers emphasize the startup and commissioning to ensure a successful qualification. We rigorously test systems during the startup/shakedown phase, resolving automation issues and refining protocols. This approach significantly reduces non-conformances in the qualification and validation stages. Additionally, we identify potential operational improvements and optimizations for end users. Join our list of satisfied clients who have partnered with us on their CQV projects.
Design Qualification and Installation & Operational Qualification
We have authored, reviewed, and executed hundreds of commissioning and qualification protocols, covering all stages from design qualification to process validation. Our process and CQV engineers are cross trained, providing a flexible workforce and systems designed for straightforward testing. Our commissioning often includes upgrades, modifications, and retrofitting of existing systems, requiring a high degree of customization. Trust our experts to prepare your CQV documents, including- but not limited to- validation master plans, project-specific plans, system classification, quality plans, change management plans, reports, procedures, SOPs, GMP alarm management, criticality and risk assessments.
Computer Systems Validation
Computer Systems Validation (CSV) With regulatory bodies enforcing stricter data integrity requirements, Cheme provides a reliable solution. Our validation engineers address the growing needs for computer systems validation (CSV) by defining validation strategies and developing and executing CSV test scripts. Cheme has successfully validated custom computerized automation systems, meeting stringent regulatory mandates for everything from simple Allen-Bradley PLCs to complex DCS like Emerson DeltaV. Trust our CSV experts to keep your systems up to date and compliant
Cleaning Validation
Cheme collaborates with clients to design, author and execute cleaning validation studies for new equipment and tanks across various drug product soils. We ensure thorough sampling procedures and robust cleaning methods. Our team trains technologists, operators, and labs on new and existing cleaning requirements. We also support mock trials and preliminary cleaning baselining. Our experts perform bridging studies to transition from cleaning validation to routine monitoring. Trust our specialists to validate and maintain your hygienic systems’ compliance.
Process Validation
Our team of PV experts understands that process validation is crucial for project commercialization. Cheme develops and executes comprehensive process validation plans, strategies and protocols. As we expand our team of process engineers, we continuously improve and maintain our knowledge and best practices to handle the delicate task of validating our clients’ GMP processes. When you need to validate your most critical processes, trust the experts at Cheme.
Thermal Mapping for Controlled Spaces
At Cheme, we offer comprehensive thermal mapping services for controlled spaces to ensure optimal environmental conditions. Our team of experts meticulously plans and executes thermal mapping studies, identifying temperature variations and ensuring compliance with regulatory standards. We use advanced data logging equipment to monitor and record temperature distributions, providing detailed analysis and actionable insights. This process helps maintain the integrity of your products and ensures the reliability of your controlled environments. Trust Cheme to deliver precise and reliable thermal mapping services tailored to your specific needs.
SU Extractables & Leachable Studies
As manufacturing facilities increasingly adopt single-use platforms, extractables and leachable (E&L) studies become essential for system validation. Cheme has extensive experience in planning and developing E&L studies and has established strong relationships with laboratories to execute and prepare results for our clients. We meticulously review vendor technical data to assess final product impact and patient safety thresholds. Ensure the performance of your single-use systems with our expert application 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
