Validations and Qualifications

“Validation is a requirement of cGMP (Current Good Manufacturing Practices)”.

IN-CAL™ has accumulated years of worldwide experience in biomedical, healthcare products, medical equipment manufacturing and pharmaceutical industries for very solid reasons. Our multidisciplinary team of professionals in metrology and validation brings in-depth technical knowledge, project management skills and regulatory compliance understanding to each project undertaken.

In today’s competitive global environment, no industry can afford to lose a piece of their business or undergo regulatory action for failure to comply with the FDA regulations. Which is why they call upon IN-CAL™ for their validation and qualification needs.

Our team of experts work together with your engineers, laboratory personnel, quality personnel and regulatory compliance team to develop a validation master plan, protocols and to identify the critical equipment / parameters within the project.

We offer the following qualification and validation services:

IN-CAL™ utilizes measuring and test equipment that is regularly calibrated for accuracy and traceable to NIST and other National Metrology Institutes. We implement 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 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 IN-CAL™, will work with you throughout the process. We guarantee that the documentation provided at the completion of each project will meet the documented protocol requirements.

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An overview of what IN-CAL™ offers:

IN-CAL™ understands that failure to comply with qualification standards can lead to regulatory actions so our goal is to provide you with expert qualification and validation services to meet your protocol requirements.