The 3 Q’s in Computer System Validation

When it comes to the FDA regulated businesses, the industries always follow the Computer System Validation approach. Managing the computer system validation process is often a comprehensive process with many steps to completion. Even one failure in the process can lead to devastating consequences for patients, as well as the company who can face warning letters from the regulatory bodies. This is why reliable validation is so crucial when it comes to the pharmaceutical, clinical, and medical device industry. IQ-OQ-PQ represents a way to ensure a reliable outcome of the validation process. In validation aspects, IQ-OQ-PQ is often referred to as the Qualification Process. To know why they are important and what they actually mean, keep reading.

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