LC/MS Instrument Qualification
Whether you require basic qualification services or something more complex, our highly experienced teams will be able to advise you on best practices and provide you with the compliance services you require. Speak to one of our specialists to find out more what we can offer for mass spectrometry instrument qualification and validation.
MS Vision provides multi-vendor compliance services comprising of IQ/OQ/PQ procedures, available to support your particular instrument configuration.
Working in a GLP environment is complex enough; our specialists can help you save valuable time in meeting compliance to regulatory demands of FDA and ISO standards.
Instrument qualification is a critical issue in GxP environments. Our specialists have established procedures available for many instruments which we are happy to discuss with you. Please keep in mind: the qualification and validation process is owned by you! We can only suggest procedures for this which are proven and established, but in the end you have to decide which procedures and criteria show that your instrument is fit for purpose. Therefore every qualification is something which needs to be discussed individually. Our starting point for this is typically the established IQ/OQ procedures of the manufacturers.
Please be aware that we cannot offer software validation! Software validation can only be offered by the manufacturer of the software, not ba anybody else.
Select The Instrument Qualification Level:
Installation Qualification (IQ):
Required for new instruments, or pre-owned but installed for the first time at your facility. IQ is usually carried out together with OQ as IQ/OQ.
The installation specification measurments are a typical example of an IQ and IQ is usually performed according to manufacturer specifications
Operational Qualification (OQ):
The OQ verifies and records instrument’s ability to meet the specified operational criteria after an installation, following repetitive use or after major service intervention
Performance Qualification (PQ):
PQ is a customer defined performance protocol that is run on your complete (U)HPLC/MS system configuration. The protocol is run following any service intervention, saves valuable analyst time and leaves your complete instrument ready to run samples. Protocols for PQ need to be supplied by the customer and agreed by both parties before the service.
Multi-vendor compliance services
MS Vision compliance services are unique due to our in-depth know-how and support of multiple brand instruments.
We offer qualification services for
- Waters Single- and Triple Quad systems (ZQD, SQD(2), QDa, Quattro and Xevo series)
- Waters TOF- and QTOF-systems (QTOF, Xevo and Synapt series)
- Sciex Triple Quad and QTrap systems (4000 and Blueline [45/55/6500])
- Sciex QTOF-systems (5600, 6600)
- ThermoFisher Triple Quad, Ion trap and Orbitrap systems
