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.
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. Here are the steps we take to ensure that your Metrohm equipment is maintained to the highest standard:
The Metrohm global Standard IQOQ Documentation has a modular structure. This allows us the flexibility to be able to Validate and document even the most complex analytical systems.
- Master Document - the documentation, its structure and content is explained in detail.
- Installation Qualification – in this section we test that the workspace is suitable and that delivery is complete. We also document the scope of instruments and accessories supplied, and that the equipment was installed properly.
- Operational Qualification - this consists of two parts:
System Component Tests (SCT)
- The individual System Components are tested according to Standard test Instructions
- After completion of the tests, calibration certificates are issued which document the results of the tests. All component test results are included in the OQ protocol
System Test - PV (Performance Verification)
- The PV is a test of the complete system in terms of the application which the customer intends to use. E.g. If you buy a KF titrator the PV will be a KF titration based on a specific procedure.
- The SOP and specifications which have to be fulfilled in order to pass the test successfully are also included in this section.