Qualification : Laboratory Weighing
Take away the guess work when you need to ensure quality and regulatory comliance. Mettler Toledo offers options for fast and professional qualification for balances and moisture analyzer. No time wasted - a quick initial qualification allows you immediately start working with your product.
Good Weighing Practice GWPRegulatory requirements for manufacturing, quality control and quality assurance continue to become stricter and more extensive.
With Good Weighing Practice METTLER TOLEDO has developed a global weighing guideline for the evaluation, operation and testing of weighing systems. GWP is a risk-based approach that interprets the regulations of each industry clearly and puts them into straightforward weighing practice. As a result, you can follow a simple program that assures compliance at any time. Due to the risk evaluation, you ensure measurement security where risks are high and save costs where risks are low.
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.
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.
- Pharma Installation Package
Stringent regulatory compliance for balances
- Moisture Installation Package
Documented installation and professional set-up for moisture analyzers
- Quality Installation Package
Meets national and international quality management requirements for balances
- Starter Installation Package
Documented installation and professional set-up for balances
Validation Service Professionals execute software specific protocols that include a comprehensive Installation, Operation, and Performance Qualification. This process will provide you with documentation that your software performs to the specifications under which it was developed. We support your needs in meeting FDA requirements for validated software as defined in 21 CFR 820.3.
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.