Mettler - Toledo Int. Inc

System Validation

0

Our software solutions FreeWeigh.Net and FormWeigh.Net have been developed for use in environments that must adhere to high quality standards. METTLER TOLEDO is committed to assisting you with information and services that ensure successful validation of a computer system.

This applies not only during the IQ, OQ and PQ validation phases, but far earlier, beginning with the first meeting, and continuing through analysis of your process, the writing of the Functional Requirement Specifications (FRS), the risk analysis and SOPs, and installation of the system by our trained service personnel. We have assembled a variety of tools for efficient implementation.

Image

EQ PAC – Equipment Validation

More than just complying with federal regulations, equipment qualification (EQ) ensures the accuracy and consistency you require in equipment performance. Since EQ is integral to the operation and success of your organization, it is critically important to make sure your equipment qualification services provide robust, complete documentation that follows cGMP best practices.

Image

Validation Manual 1 - FormWeigh.Net

The FDA requires manufacturers in the pharmaceuticals industry to conduct a vendor audit for all software packages they use.

Image

Validation Manual 2 - FormWeigh.Net

Validation Manual 2 contains the IQ and OQ processes for a FormWeigh.Net system. It leads the user through the entire process, supplies all the necessary protocols, and describes the tests to be conducted. Consequently, Validation Manual 2 saves your internal validation team an enormous amount of time and work, which can minimize your validation costs.

Image

Validation Manual 1 - FreeWeigh.Net

The FDA requires manufacturers in the pharmaceuticals industry to conduct a vendor audit for all software packages they use

Image

Validation Manual 2 - FreeWeigh.Net

Validation Manual 2 contains the IQ, OQ and PQ processes for a FreeWeigh.Net System. It leads the user through the entire process, supplies all the necessary protocols, and describes the tests to be conducted. Consequently, Validation Manual 2 saves your internal validation team an enormous amount of time and work, which can minimize your validation costs.

Image

Validation Manual 2 - SQC14

With the standalone filling process control system, you can be sure you are complying with the legally required minimum fill quantities. And the validation manual allows you to meet the legal validation requirements. We can support you with a validation manual for this special system in both German and English that contains step-by-step instructions for the Installation Qualification (IQ), Operational Qualification (OQ) and Performance Qualification (PQ) phases.You no longer have to write your own validation documents for IQ, OQ and PQ.

Image

Validation of Computer Systems

We support you on-site with planning and implementation during all phases of validation. From assistance with writing the specifications, risk analysis and SOP, through conducting the IQ, OQ and PQ, and finally, with the traceability matrix. Thanks to our years of experience, we can help you through these process steps efficiently and professionally.If you have your own presentation for IQ, OQ and PQ, or your own approach to the qualification steps, we can also adapt the phases to your individual requirements.

Customer reviews

No reviews were found for System Validation. Be the first to review!