IQ/OQ/PQ of Analytical Instruments
Installation, Operation and Performance Qualification (IQ/OQ/PQ) of Analytical Instruments
Our IQ OQ PQ qualification and validation programs help your company assess, develop and implement regulatory compliance at the level you need, including the FDA’s Rule 21 CFR Part 11 and the EPA’s CROMER.
As your partner, we can determine the level of compliance and validation appropriate for your company. We then customize our services to compliment your in-house compliance and qualification / validation programs, allowing you to optimize resources.
Our qualification / validation offers:
IQ - Installation Qualification
Complete maintenance history, system history and inventory of components and documentation.
Verification of components' installation including electrical, plumbing, and communication connections.
OQ - Operation Qualification
Verification of components' functionality, operation, and conformity to manufacturer's specifications.
PQ - Performance Qualification
Performance verification of laboratory equipment for routine R&D, QA/QC, EPA, FDA, and client-compliance operation.
Some of the instruments that we qualificate are:
HPLC systems
- Isocratic pumps
- Gradient pumps
- Column ovens
- UV-Vis detectors
- Diode Array detectors
- Fluorescence detectors
- Refractive index detectors
- Electrochemicals detectors
- Conductivity detectors
- Autosamplers
Gas Chromatographs
- Ovens
- Injectors
- Manometers
- Flowmeters
- FID, NPD, FPD, ECD, TCD detectors
- Headspace samplers
Ion Chromatography systems
- Spectrophotometers
- Atomic Absorption Spectrophotometers
