Whether you are running tests in a laboratory, gathering data in the field or operating medical devices on behalf of patients, you must be able to trust that your equipment is consistently performing as intended and that the data is accurate.
Equipment validation, often referred to as IQ/OQ/PQ, provides a way of assessing quality through how the equipment functions and whether it meets requirements. IQ/OQ/PQ services may be required by association, state or federal guidelines depending upon the industry and the supervising regulatory agencies.
Installation Qualification (IQ)
When new equipment and software is received, IQ must be conducted to validate the equipment is producing accurate results and transmitting the data to the workstation where the software is installed. This initial step confirms that the equipment and software has been installed as outlined by the manufacturer and is working properly.
Operational Qualification (OQ)
OQ can only be performed after a successful IQ. During this phase, the equipment is tested to ensure consistently operating as designed and that it’s meeting user requirements. Each component of the system must be individually tested and documented to validate it’s operating as it should
Keep in mind, requalification must be carried out after any maintenance work or modifications to the equipment, and during routine quality assurance audits.
Performance Qualification (PQ)
This final step involves verifying and documenting that the equipment is consistently producing acceptable results under the normal operating conditions. PQ is testing how the equipment works as a system instead of individually. But before PQ begins, a detailed assessment plan must be created based on the process description.
MadgeTech offers on-site IQ/OQ/PQ services to help customers validate their data logger systems. With the help of our expert technicians, this service is a cost-effective way to ensure proper implementation while saving time and minimizing disruptions to staff and operations.
For more information give us a call at (603) 456-2011 or email us at [email protected]