Instrument Qualification consists of four phases:
- Design Qualification (DQ): pre-purchase checks that the item is suitable for its intended purpose.
- Installation Qualification (IQ): on-receipt checks that the equipment has been delivered and installed in good working order and is suitable for use in the intended measuring environment.
- Operational Qualification (OQ): proof that the equipment functions to its operational specification in the designated measuring environment.
- Performance Qualification (PQ): ongoing checks that the equipment is meeting user requirements throughout its entire working life.
Reagecon offers full assistance in meeting DQ requirements and offers a fully-documented IQ & OQ service for a broad range of equipment. We also offer a Re-Qualification Service – the periodic repeat of the OQ tests that must be performed throughout the equipment’s operational life:
- Detailed protocols including traceable certificates for all of Reagecon’s instruments and standards.
- Proof that your equipment is suitable for your intended use – where possible, we will tailor PQ to meet your specific requirements.
- Expertise in the analytical discipline and in Qualification – this ensures compliance with the latest regulations, e.g. USP chapter 1058.
- An efficient and effective service.