Professional Calibration Qualifications
IN-CAL has over 20 years of experience in biomedical, healthcare, medical, manufacturing, and pharmaceutical equipment calibration. Our multidisciplinary team of professionals in metrology and validation brings in-depth technical knowledge, project management skills, and regulatory compliance expertise to each of our customers’ requests.
In today's competitive global environment, no industry can afford to lose a piece of its business or undergo regulatory action for failure to comply with FDA regulations. That’s why companies call us at IN-CAL for professional calibration qualifications.
Our team of experts works together with your engineers, laboratory personnel, quality personnel, and regulatory compliance team to develop a validation master plan and to identify the critical equipment and parameters of the project.
We offer the following qualification and validation services:
- Calibration Validation, Calibration Qualification
- Process Validation
- Methods Validation
- Facility Qualification
- Equipment Qualification (EQ), including:
- Design Qualification
- Installation Qualification (IQ)
- Operational Qualification (OQ)
- Performance Qualification (PQ)
Your Source for Calibration Qualification
IN-CAL utilizes measuring and test equipment that is regularly calibrated for accuracy and traceable to NIST. We implement qualification systems so we can accurately calibrate analytical equipment per standard operating procedures. Our highly trained technicians will apply quality assurance standards throughout each process to ensure compliance with FDA regulations.
In addition, our professional team will assist you in resolving any deficiencies or non-conformances that may occur during the validation or qualification process, including a review of gap analysis and recommending corrective actions.
Whether you need validation or qualification for your lab equipment, environmental chambers, torque test system, or other equipment, you can be assured that we will work with you at every step of the process. The validation process will assure that the manufactured product will be consistent and will comply with FDA regulatory requirements.
We guarantee that the documentation provided at the completion of each project will meet your company's quality requirements as well as both national and international standards and regulations.
An overview of what we offer:
- Initial review of equipment qualification to determine the extent of service required
- Comprehensive qualification services for all phases of qualification - PQ, IQ, and OQ
- On-time services, when you need it
- Ongoing qualification service to ensure product integrity throughout the life of the equipment
We understand that failure to comply with qualifications standards can lead to regulatory action against your company. Therefore, it is our goal to provide you with expert qualification, validation, and calibration services so you have confidence in your lab and manufacturing equipment.