If you are developing, designing or manufacturing analytical instruments for laboratory use, you will need to have documentation that records, in detail, how your product was developed, designed, manufactured and tested.
If you are supplying, servicing or calibrating analytical laboratory instruments, your client laboratory will request documents describing the procedures your representatives follow when installing, calibrating or servicing the instruments. These documents will need to be in sufficient detail to enable the process to be consistently reproduced. Your documents will also need to be written in a way that can be easily understood by a trained but uniformed person without having to refer to the originator.
INSTRUMENT QUALIFICATION FOR LABORATORY SERVICE BUSINESSES
We have over ten years of experience developing qualification and maintenance programs for laboratory instruments and can offer consultancy, advice and assistance with:
Developing installation, calibration and maintenance procedures
Compiling written procedures that conform to your client’s needs and expectations, such as:
Instrument Qualification Plan
The Instrument Qualification Plan Identifies the activities required to be performed to provide a high degree of assurance that the installed laboratory instrument will consistently deliver results meeting predetermined quality attributes.
Design Qualification (DQ)
Design Qualification documents how the laboratory instrument was designed, developed, manufactured and tested. The DQ protocol also documents how the instrument conforms to the customer’s user requirement specification (URS) and to the requirements of GLP, GMP and ISO 17025.
Risk Assessment (RA)
Assessing the potential quality, compliance and business consequences of a failure of any functionality of the laboratory instrument and identifying required mitigation activities
Installation Qualification (IQ)
I can help you develop the IQ protocol, that documents the instrument was installed as specified. The IQ protocol should also establish the laboratory instrument’s environmental requirements.
Operational Qualification (OQ)
The OQ protocol documents that the instrument operates in accordance with established operating specifications in its installed environment. The OQ protocol should also establish testing procedures for the installed instrument, and I can assist you with developing appropriate procedures