Our team of experts works closely with clients to tailor our solutions to their unique requirements. By fostering open communication and collaboration, we gain a comprehensive understanding of project goals and challenges, enabling us to design effective strategies and protocols.

Integrated CQV Approach

Critical Mass Consulting offers end-to-end integrated Commissioning, Qualification, and Validation services that streamline your validation lifecycle. We meticulously plan and execute commissioning activities, verifying that equipment, systems, and facilities are installed and functioning correctly. Our qualification services focus on thorough testing, data analysis, and documentation, ensuring that equipment and systems meet predefined acceptance criteria. Finally, our validation expertise allows us to establish documented evidence that processes and systems consistently produce results within predefined parameters and adhere to rigorous quality standards.

Modern, Lean Validation Methodologies

We implement modern, risk-based validation approaches such as ASTM E2500 and Computer Software Assurance (CSA) that focus on critical aspects and functions affecting product quality and patient safety. Our lean methodology emphasizes efficient verification of critical requirements while streamlining documentation and testing efforts on non-critical elements. This approach not only ensures regulatory compliance but also reduces validation timelines and costs without compromising quality or safety.

Digital Validation Solutions

Our validation specialists are proficient in implementing and working with various digital validation platforms including ValGenesis, Kneat, and other industry-leading solutions. We seamlessly integrate with your existing digital infrastructure or help you transition from paper-based to digital validation systems. This expertise allows us to deliver more efficient, compliant, and future-ready validation outcomes for your organization.

With Critical Mass Consulting, you can trust in our ability to navigate the complex landscape of CQV, delivering efficient and reliable outcomes for your critical projects.