Qualification : Industrial Weighing
There is an ever increasing awareness of the need for assurance that products are safe and of a consistent quality. Consequently, as a manufacturer, you must document that processes are proven and that equipment is qualified to produce results that meet specifications. METTLER TOLEDO has qualification protocols and documentation solutions that satisfy the demands of the FDA and other regulatory bodies.
Your benefits from our expertise:
- Cost savings of a factory-developed qualification protocol
- Timely production readiness with correct equipment set-up
- Improved productivity from timely user training
- Qualified performance with regulatory compliant procedures
- Qualification documentation meeting regulatory requirements
IPac is designed to be consistent with the requirements of GMP and other quality systems. Execution of an IPac by a trained METTLER TOLEDO service representative delivers a self-contained solution for new equipment qualification or for re-qualification of equipment that is re-purposed, moved or lacks adequate documentation.
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.