Quantus stands out due to our personalized, tailored services that align with the unique needs of your proprietary operations. Our team is specially trained to operate within regulated GMP and GLP environments, adhering to Good Documentation Practices (GDP).
We leverage advanced technology to enhance performance and efficiency, ensuring that our services scale with your operations while maintaining the highest standards of precision and compliance.
At Quantus, we rigorously adhere to industry standards such as ISO and FDA regulations. Our Qualification Services are designed to meet the specific requirements of your environment, including Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ).
We ensure that all equipment and processes are validated to meet these stringent standards, helping you maintain compliance and avoid costly disruptions.
Quantus follows a meticulous documentation process, guided by our SOPs, to ensure that every step of the qualification process is accurately recorded. Our documentation practices are designed to meet both client and regulatory requirements, providing you with comprehensive reports and validation binders that are easy to audit.
We also offer customized documentation packages to suit your specific needs, whether you require advanced, standard, or basic data-only reports.
Requalification is a critical part of maintaining the reliability of your equipment. Quantus recommends requalification every 12 months or whenever significant changes occur, such as repairs or relocations.
Our requalification services include thorough testing and validation to ensure that your equipment continues to meet the required standards, helping you avoid any operational risks and ensuring continuous compliance.
Quantus uses state-of-the-art equipment and methodologies to perform precise qualification services. Our team is trained to execute these services with the highest level of accuracy, and we ensure traceability of all measurements to NIST standards. By maintaining a robust Quality Management System (QMS) and following strict SOPs, we deliver reliable results that you can trust.