What IQ/OQ/PQ Services Are- and Why You Need Them
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 performing well and that the data you are receiving is accurate.
Equipment validation – often referred to as Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ) – provides you with a way of assessing how well your equipment is functioning. IQ/OQ/PQ may also be required by association, state, or federal guidelines depending upon your industry and the regulatory agencies that oversee your work.
Installation Qualification (IQ) IQ happens when you purchase or upgrade your equipment and software. IQ starts when you receive the product and ends with the knowledge that correct information can pass between the equipment and the workstation where the software has been installed. For example, if you purchased a wireless temperature monitoring system, you'd verify that you received everything in good condition, had full supporting documentation, installed the temperature recorder, and that the data logging software was sending information that was being received by your workstation.
Operational Qualification (OQ) OQ can only occur after a successful installation. During this phase, you'd ensure that your data loggers are recording and sending accurate information to your workstation. You would also ensure that proper procedures are established and followed for the main functions of the new system and that handling and maintenance information was available. OQ would be completed when you verify that the data logger system is operational.
Performance Qualification (PQ) PQ takes place as your new system is used. You may be given recommendations to enhance the long-term accuracy of your data logger system, along with information about periodic maintenance needs. The system will likely require periodic calibration as well. PQ ensures that your data logging software and equipment perform acceptably – or even exceptionally well – over time.
Why IQ/OQ/PQ Matters To You These structured forms of verification and validation can be essential for many reasons. If your company reports to any regulatory agencies, the process leaves you with necessary documentation to prove to auditors, investigators, and the like that you take their regulations seriously and that the information and services you provide conform to industry standards. Within your own organization, it gives insight into processes and procedures as well as employee performance, which can lead to improvements in efficiency and innovation. It also gives you an effective means of evaluating the equipment and software provided by your vendor, which will be invaluable when the time comes for investing in new systems or upgrading your existing ones.
MadgeTech offers Secure Data Logging Software including IQ/OQ/PQ protocols to aid in compliance with 21 CFR Part 11. On-site IQ/OQ/PQ services are also available for protocol generation, training and validation assistance. With the help of expert MadgeTech employees, your company will save time and money and minimize staff disruption while implementing IQ/OQ/PQ protocols for your MadgeTech data logger system. After working with MadgeTech, you'll receive a comprehensive final report that documents all of the testing performed, the results that were obtained, and recommendations for testing, future performance qualification, and ongoing maintenance that is customized to your site.
