Validation

In these days of audits and inspections you are no doubt aware of the need to ensure that your Metrohm instrumentation is not only maintained and regularly checked, but that all service work and checks are thoroughly documented. 

This requirement starts from the point of purchase and involves the Installation and Operational qualification (IQ/OQ) of the instruments, as well as analytical checks of your complete Metrohm system.

By doing this you are able to provide comprehensive documentation to subsequent auditors and regulatory bodies that the equipment is fit for purpose.
Metrohm can tailor a package to match your requirements.

Installation Qualification

Installation qualification ensures that the instrument is installed according to the manufacturer and user requirements, and that all supporting documentation, spares, consumables and utilities are supplied or recommended. Operational Qualification ensures that the equipment will perform to its operational specification by testing and documenting key operational parameters relating to the individual instrument. All tests are based on Metrohm standard service procedures.

Operational Qualification

The Operational Qualification (OQ) comprises a set of formalised tests that are intended to establish that the system comprising the instruments and accessories, function correctly within the manufacturers operational specification. The criteria measured and the tolerances set, reflect the critical key parameters that are required to ensure performance over a wide range of designated uses.

The Operational Qualification tests are carried out according to a strict protocol and involve the measurement of key parameters using test equipment and reference standards that are calibrated and traceable to National standards.

Basic Functionality Check

For systems where only IQ/OQ are required, a basic functionality check is carried out to ensure the system performs adequately. This involves running 3 samples using standard reference materials and checking the accuracy and precision.

Performance Verification

The system is validated by measuring parameters such as accuracy, precision and systematic error using certified standard materials and reagents. This involves running 10 consecutive samples and analysing the data obtained.

Complete documentation is provided including engineer training certificates, test reports for burette calibrations, certification for all reagents and standards and certification for all measuring test equipment.

Re-Validation

Ensuring your critical systems are re-validated at regular intervals can be expensive and also very time consuming.
To satisfy audits and inspections as well as customer demands, Metrohm UK now offer complete cost effective re-validation packages.

These comprehensive packages include:
 

• Operational Qualification documentation for each individual instrument
• Basic Functionality check or Performance Verification documentation for your complete Metrohm system
• Certification for all measuring test equipment used
• Certification for all reagents and standards used
• Test reports for all relevant burette calibrations
• Engineer Training certificates

We can schedule and complete your system re-validation quickly and efficiently leaving you with more time to concentrate on the increasing demands placed on an analytical laboratory.