Qualification : Process Analytics
Working in a regulated environment, you need to be confident that your instruments are compliant to the latest FDA regulations and USP standards. METTLER TOLEDO Regulatory Compliance Specialists have developed qualification and validation protocols specifically for our instruments. Since we are most familiar with how our instruments are designed to perform and operate, we can complete equipment qualification and support software validation efficiently, while minimizing your risk of noncompliance.
Compliance to international standards is critical to ensure quality of your water purification process. THORNTON is leading in international USP, EP and JP standardizing efforts and hence its products meet all global conductivity and TOC requirements for Purified Water, Highly Purified Water, and Water for Injection in compliance with USP <645> – conductivity, USP <643> and EP2.2.44 – TOC.
Qualification Service Professionals complete equipment specific protocols that include a comprehensive Installation, Operation, and Performance Qualification. METTLER TOLEDO Equipment Qualification Services executed at your location, provide you with the most efficient way to achieve and maintain compliance with FDA requirements for qualified equipment as defined in 21 CFR 211.68.
Once you have completed the initial qualification, it is important to verify performance on an on-going basis. METTLER TOLEDO Service Professionals can execute scheduled verification testing of existing systems to document continued compliance to manufacturer’s specifications and industry standards.
The FDA requires regulated companies to establish and follow Standard Operating Procedures (SOPs) for instrument operation, calibration maintenance, software backup and archival strategies. METTLER TOLEDO has experienced Regulatory Compliance Specialists that can support you in drafting SOPs for your new and existing instruments.