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IQ OQ PQ Validation in San Francisco and San Diego

At Biotechnical Services, Inc., we provide all aspects of IQ OQ PQ validation in San Francisco. The validation acronyms mean Installation Qualification, Operational Qualification, and Performance Qualification. These three validation processes are independent and check critical elements in equipment software, piping, and mechanical systems. When you contact us for IQ OQ PQ validation in San Francisco and San Diego, we ensure that your systems are installed correctly, meet the specifications and design requirements, and operate according to the design when under a load. These validation procedures are mostly used in medical devices, life sciences, and pharmaceutical industries. A small error can lead to serious and deadly consequences when qualifying or commissioning a new process. For that reason, at Biotechnical Services, Inc., we provide a comprehensive and precise IQ OQ PQ validation in San Francisco and San Diego to ensure the safety of your system’s processes. Our lab equipment validation processes is scientifically accurate and provide reliable performance for your system.

What is Installation Qualification (IQ)?

Installation Qualification is documented evidence that proves that critical equipment has been properly delivered, correctly installed, and correctly configured according to the approved standards of the manufacturer. When performing an installation qualification task, equipment installation is verified using a checklist prepared by the manufacturer. The checklist ensures that the components being installed meet the specified procedure. The installation qualification process is done by Validation or Commissioning and Qualification technicians or engineers. The process entails verifying the technical specification of the equipment and the operational requirements match with the elements of the desired facility. When the equipment is delivered, a cross-checking of the packaging list is carried out against the contents of the equipment components. After delivery, confirmation is done to ensure that the equipment is installed correctly. All the wiring and piping components to other units are verified when the equipment has been installed. The environment, such as the laboratory, has to meet the manufacturer’s installation guidelines. When everything is set, the equipment software is installed, and the firmware version is recorded together with the equipment calibration dates. The entire installation qualification process is recorded in a pre-approved checklist and signed by the validation officers. When you hire us at Biotechnical Services, Inc., you are sure you are getting trusted installation qualifications. We offer timely and professional IQ OQ PQ validation in San Francisco and San Diego.

What is Operational Qualification (OQ)?

Operational Qualification is documented evidence proving that the system operates according to the manufacturer’s design. It is a procedure to confirm that the equipment operates or runs as expected. When carrying out its Commissioning and Qualification, the engineers usually work together with the instrumentation and mechanical engineers, automation, chemical, process, and maintenance personnel. These professionals test the equipment to confirm its performance and meet its design specifications. Features to be tested during Operational Qualification include:

  • Overheating and low-temperature alarms
  • Temperature control systems
  • Fan, motor speed, and RPMs
  • Operational signals
  • Pressure control systems
  • Display units and machine interface units

What is Performance Qualification (PQ)?

Performance Qualification is a documented process that proves that the system or equipment meets user requirements. Performance qualification is usually the last step in equipment qualification. Unlike operation qualification, performance qualification is conducted when the equipment or system is under a load or a medium. The test is done with real-world conditions. The phase is vital as it proves the individual components of the equipment work as expected. When conducting a performance qualification, these faults might be detected:

  • Combination of individual faults
  • Pressure differentials
  • Process media backflow
  • Excessive heat
  • Excessive noise or vibration

If you need to detect these problems and fix them, consider hiring us at Biotechnical Services, Inc. We have a specialized team of competent professionals who provide extensive performance qualifications for your system. We employ the latest technology when carrying out our validation processes. Our modern validation system ensures that we offer the best IQ OQ PQ validation in San Francisco and San Diego.

What is The V-Model in Direct Impact Systems?

The V-model is a method for comparing and visualizing the relationships between detailed design, functional design, and user requirements for operation qualification, installation qualification, and performance qualifications. By employing this modern method, Biotechnical Services, Inc. ensures that you get the best IQ OQ PQ validation in San Francisco and San Diego.

Since the validation process is complex, you should consider working with the experts. At Biotechnical Services, Inc., we ensure that you get seamless validations for your systems. Having worked in the validation field for over 30 years with excellent reviews from our past clients, we have proved to be the leading contractors for IQ OQ PQ validation in San Francisco and San Diego.