The Challenge

Once equipment or a system completes its initial qualification, it enters routine production and must be maintained in a validated state for the rest of its lifecycle. Many regulated industries expect annual requalification — but mechanically repeating every IQ and OQ test from scratch consumes weeks of qualification effort, ties up the equipment, and often produces no new information beyond what routine monitoring already proves. The real question is: which tests genuinely need to be repeated, and which add no value?

The Approach

Arnan developed a structured risk-assessment methodology that systematically evaluates every IQ and OQ test against criteria such as criticality of the function tested, likelihood of change over time, history of failures, coverage by routine monitoring, and direct impact on product quality.

The output is a documented decision for each individual test — repeat as-is, modify and repeat, or omit — with a scientifically justified rationale captured for every line item. The methodology gives QA and Validation a defensible record that holds up under regulatory inspection, while letting operations skip work that produces no real evidence of continued fitness for use.

The Outcome

• A comprehensive risk-assessment document defining which tests must be repeated
• Clear scope reduction with full traceability of every decision
• Regulatorily defensible rationale for omitted or modified tests
• Significant time savings and optimised resource allocation across years
• Equipment maintained in a validated state with no compromise to compliance