Checks may also include the memory of the workstation on which the software is being installed, the operating system, software libraries, and that all required files to run the application are accounted for. The OQ, or Operational Qualification, is next up. It is traditionally started out once the IQ has been run through, acting as a pre-requisite for technical acceptance of the software, equipment, or facility.
In this capacity, the OQ tests that the functionality of a product is as desired. It acts as a review of start-up, operational, maintenance, safety, and cleaning procedures where applicable. This holds true for both software and hardware and includes everything from the smallest of details on displays to the exact range of temperature fluctuations, etc.
The final step in the qualification process, the PQ, or Performance Qualification, is meant to ensure the product stacks up against real-world conditions, albeit in simulated scenarios. Whereas the OQ verified functionality, the PQ is results-oriented.
Tests tend to have expected results attached to them, meaning they have to be consistently reproducible. The detailed test plan itself is created from the product development lifecycle. Both the Functional Requirements Specification FRS; document detailing the requirements that are expected to be performed and Detailed Design Specification DDS; document detailing how those operations are performed factor in.
System and unit testing testing done at the modular level are also taken into consideration. The goal here, aside from making sure everything works, is to make sure the system is able to be validated.
After all, the validation document serves as proof that the system works as expected when it is being installed at a customer site. That documentation is something the customer holds onto, if ever an issue or audit arises sometime down the line.
The whole is greater than the sum of its parts, though. Take, for instance, GlobalVision, which develops automated quality control software and various hardware accompaniments like scanners for packaging components and product collateral.
GlobalVision offers validation execution services with industries like pharma in mind. Pharma is renowned for its stringent requirements revolving around standard documentation and GlobalVision has decades of experience within that space, among others, and caters to the top 10 pharma companies in the world.
Operational qualification OQ is performed after meeting each protocol of IQ. In action, this means identifying and inspecting equipment features that can impact final product quality. During OQ, all items in the test plan are tested and their performance is thoroughly documented. Since this is a prerequisite for acceptance of equipment and the facility, it can only be conducted once the IQ is run. Every unit of hardware and software must be shown to be operating within the specified limits.
These often include but, again, are in no way limited to the following:. The final step of qualifying equipment is PQ. In this phase, the qualification and validation team verifies and documents that the user requirements are verified as being met.
These user requirements should include the normal operating range required as defined and signed off on by QA and verified in the DQ. Once you've qualified the equipment, you can develop each process required for each product. Then, once each process is fully developed, it can be validated. Instead of testing components and instruments one by one, PQ tests them all as a partial or overall process. Before they start qualifying, however, the team must create a detailed test plan based on the process description.
This is one area where a third-party specialist can and often should be brought in to ensure thoroughness and accuracy. CKmtl: it's probably not that the 'PQ still works' so much as that the postal code is correct. I happened to mention this question to my aunt. She took it upon herself to look through her federal tax records, which include an address label generated by the federal gov't. On those, the last year that the provincial postal abbreviation was PQ is From onward, it's QC.
The rest are all letters. Sepomex and the Federal gov't will have to put their foot down someday and decide, is all. I believe, however, that my original reason still stands. I was talking about the official ones.
I vaguely recall someone corroborate this?
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