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Social iconsTransition from blueprint to breakthrough with our comprehensive CQV Services
Guiding you smoothly from conceptual design to full-scale operation, our expert Facility Commissioning and Validation Services ensure a seamless transition from construction to production. Our holistic approach includes:
Choose our services for a GMP-compliant facility meticulously constructed to specifications and validated for excellence. Rely on Quantus to redefine excellence in facility commissioning, qualification, and validation, safeguarding your processes against contamination, and ensuring your operations are robust and scalable.
Our facility validation encompasses a comprehensive suite of services to ensure your facility not only meets but exceeds industry expectations:
Focused Commissioning: We initiate with a meticulous commissioning phase to verify that all systems and utilities are installed and function in line with precise engineering specifications.
Calibration Assurance: Our rigorous calibration protocols ensure that all measurement equipment operates with unparalleled accuracy and compliance.
Equipment Qualification: We conduct thorough qualifications of your equipment to confirm it meets all operational requirements and specifications.
EMPQ Proficiency: Our Enhanced Model for Process and Product Qualification (EMPQ) capability provides a robust framework that integrates process, equipment, and facility validation, ensuring a holistic approach to your facility’s validation needs.
By integrating these critical components, we deliver a validation service that not only establishes a solid foundation for your operations but also supports your journey through the full lifecycle of your facility's GMP compliance.
Commissioning Test Plans (CTPs) are critical components of our comprehensive approach to facility validation, designed to ensure that your systems and equipment are set up for success right from the start. Here's what they involve:
Integration with System Acceptance Tests (SATs):
Inspection and Verification:
Operational Readiness:
For smaller scale projects, we utilize streamlined commissioning checklists to efficiently cover all critical aspects without overcomplicating the process. These checklists are enhanced to ensure:
Our CTPs are meticulously tailored to meet the specific needs of each facility, ensuring a solid foundation for successful production and subsequent qualification phases. This strategic approach not only saves time and resources but also instills confidence that your facility will meet all operational expectations with assured compliance.
Yes, our services can be tailored using off-the-shelf templates or custom protocols to fit the unique needs of your facility.
Commissioning is the initial step in the CQV process, confirming that the facility's design and construction align with the intended operational capabilities, without yet considering the direct product impact.
Our services are built around ISPE's guidelines, ensuring industry best practices are met during the commissioning phase. We focus on satisfying engineering requirements and creating a compliant groundwork for production.
Our precision, attention to detail, and commitment to regulatory compliance ensure that your facility is not just built to the highest standards but also prepared to meet the rigorous demands of clinical excellence.
I am very pleased with the services provided. The technicians are exceptional to work with, and the customer support team is incredibly responsive and accommodating. The pricing offers excellent value for the services provided.
Century Therapeutics Drew
The technicians here do an outstanding job. I truly appreciate the responsiveness of the customer support team and their proactive approach to scheduling.
Ellume Ken
Everything is going great with the services. The technicians are top-notch – professional, honest, and very solid in their work. They provide excellent communication and feedback.
RegenXBio Blake
Working with Quantus to resolve the disorganization of previous 3rd party reports. I have received positive feedback on the work Quantus is doing. We're looking forward to a meeting with the top management and business development teams to gain more feedback and develop additional controls.
Christiana Care James
Ensure optimal sterilization, verifying low non-condensable gases, superheat, optimal dryness, and clean steam to meet stringent healthcare standards.
Stay compliant with our routine Autoclave Calibration Services every six months, ensuring accuracy and reliability between re-qualification periods.
Essential services for Life Sciences facilities ensuring the highest standards of sterility and safety. Our approach targets the heart of microbial risk.