(info@in-cal.com)
IN-CAL™
71C Pine Rd.
Hudson, NH 03051
Fax 603.883.6667
Call 603.883.5558
Email (info@in-cal.com)
|
|
| ISO 9001:2000 Registration |
|
|
|
ISO/IEC 17025:2005 |
Validations and Qualifications
Professional Calibration Validation
"Validation is a requirement of cGMP (Current Good Manufacturing Practices)".IN-CAL™ has accumulated more than 15 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 its 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:
- 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 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 at every step of the process. Validation process will assure that the manufactured product will be consistent and will comply with the 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 IN-CAL™ offers:
- Initial review of equipment qualification to determine 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
Calibration Services by Industry | Custom Manufacturing | Dimensional Calibration | Electronic Calibration | Environmental Mapping | Equipment Calibration
Mechanical Calibration | On-Site Calibration | PLC Design | Temperature Calibration | Temperature Profiling | Calibration Site Map
Hudson, NH Website Design Development