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Independent Verification


Independent Verification is the evidence-based process of objectively evaluating and confirming, by an independent qualified person or persons, that a given operational process or system, or any associated element or sub-element of such a process or system is conducted in accordance with associated regulatory expectations (regulations and/or guideline and guidance documents, as applicable) and that they conform to established criteria.

Independent Verification confirms that a client’s given operational process or system is thoroughly evaluated and provides evidence-based confirmation that the established processes and systems are acceptable to control product quality. RegDev uses an evidence-based Independent Verification approach. This allows for objective evaluation and confirmation of data accuracy and information supporting the quality of each process, system, or product being verified.

Independent Verification — Service Details


A comprehensive inspection of a pharmaceutical production company or vendor to ensure compliance with set quality standards.

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Establishes processes and deliverables that meet specific requirements to enable regulatory review.

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Determines if there are any areas that need to be corrected before an official PAI is run.

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