Validation and Qualification
Lab equipment validation involves a set of independent procedures that are used to check if a product meets the specifications and requirements of its intended purposes.
Why Raeyco?
In highly-regulated industries, small inconsistencies can compound into serious issues without the proper qualification and validation protocols in place.
As a component of quality assurance, equipment validation is absolutely critical to GMP organizations. One of the key sets of protocols within equipment validation is Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ).
For many companies, validation is the most time consuming and document-intensive part of compliance. Our proven process and reporting template drastically reduces validation time. We offer a full array of validation solutions and services based on regulatory guidance to help you maintain compliance. From temperature and pressure mapping, to protocols specific for your business needs, we offer a consistent digital solution that will stand up to any audit. All reporting is provided through our proprietary software system, Labforce.
What does IQOQPQ mean?
IQ: Instrumentation Qualification. The instrument and all its components and documentation are installed and configured according to the manufacturer’s specifications or installation checklist. Re-qualification should also be performed as part of routine quality assurance processes
OQ: Operational Qualification. All the major parts of the instrument are tested to ensure they all perform correctly. This determines that equipment performance is consistent with the user requirement specification within the manufacturer-specified operating ranges.
PQ: Performance Qualification. The documented collection of activities necessary to demonstrate that an instrument consistently performs according to the specifications defined by the user and is appropriate for intended use. It requires performance checks to be made through a series of tests.
Validation and Regulatory Compliance
- Expertise in regulations for Canada (Health Canada), the United States (FDA), and the International Organization for Standardization (ISO)
- Commissioning/Decommissioning and validation documents
- Conformity and GMP audits
- Protocol development and paperless reporting via Labforce software
Frequently Asked Questions
Why trust Raeyco to perform validation and qualification services over other companies?
At Raeyco, we are experts when it comes to validation and qualification services. Our paperless process helps reduce time and costs. Using our proprietary software enables us to customize your protocols and reports as needed.
How do we sign up to get validation and qualification performed by Raeyco?
Contact our sales or customer care team for a quote.
Where in Canada does Raeyco provide validation and qualification services? Will Raeyco travel outside of Canada to perform validation and qualification?
Raeyco provides validation services in BC, Alberta, Saskatchewan, Manitoba, Ontario, Quebec, the Atlantic provinces, the Yukon, the Northwest Territories, and Nunavut. Raeyco also provides calibration services in the USA.
How soon can I get Raeyco to come perform validation and qualification services, and how long will it take?
We would need to do an initial discovery call to determine user requirements and conditions of the validation, and then prepare the protocols. Once we assemble the necessary tools and standards, we can schedule your service! The process can take anywhere from 1-3 days.
What documentation does Raeyco provide as proof that standards have been met?
You will receive the raw data and a full validation report.
What guarantees does Raeyco offer that its validation and qualification services will stand up to an audit?
Your validation report will include all the details to ensure full compliance.
How often does my equipment need to be re-validated and re-qualified?
This is up to you! Many customers validate their equipment annually.
What types of equipment should receive regular validation and qualification?
Any equipment where maintaining compliance is a priority! We validate autoclaves, all types of chambers, spectrophotometers, freezers, fridges, GC’s – there is nothing we can’t do!
How does Raeyco help streamline the validation and qualification process?
By using our customizable protocol templates and validation reports, available on our proprietary Labforce software, we are able to expedite the process and save you time and money!
What is the difference between IQ, OQ and PQ?
IQ: Instrumentation Qualification. The instrument and all its components and documentation are installed and configured according to the manufacturer’s specifications or installation checklist. Re-qualification should also be performed as part of routine quality assurance processes
OQ: Operational Qualification. All the major parts of the instrument are tested to ensure they all perform correctly. This determines that equipment performance is consistent with the user requirement specification within the manufacturer-specified operating ranges.
PQ: Performance Qualification. The documented collection of activities necessary to demonstrate that an instrument consistently performs according to the specifications defined by the user and is appropriate for intended use. It requires performance checks to be made through a series of tests.