Qualification & Validation with IQ, OQ and PQ
Raeyco provides validation services that will stand up to any audit – we guarantee it!
If you are a Biotech or Pharmaceutical company, you are required to hold yourself to the highest standards resulting in product quality, safety and traceability. Health Canada and the US FDA will likely subject your Laboratory to regulatory requirements for equipment qualification and computer system validation to ensure your processes are met. We can help your Lab achieve this and we will provide you with onsite or phone support 24/7 if ever you are audited and require information from us.
We provide various levels of support:
Laboratory Validation is a process that is employed to ensure that laboratory test data and results are consistent, accurate and precise. The validation process for test methods, as well as the instrumentation that is used to perform the analysis, have IQ, OQ and PQ protocols.
Laboratory equipment should be qualified with IQ, OQ and PQ protocols to demonstrate suitability for the intended use. Laboratory systems including equipment are amongst key targets of Health Canada or FDA inspections. They are considered high risk systems because they can have a high impact on product quality.
Calibration and Verification
Calibration, as a concept, means that something is out of adjustment and by this action, it is brought back to adjustment and verification is to monitor performance.
Call us for Qualification & Validation services today .