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EngineRoom Software Validation: Calculate with Confidence

September 29, 2021

It's helpful to know the numbers you're crunching during a Six Sigma project are accurate, but in some industries, it's more than about simply peace of mind.

Companies subject to U.S. Food and Drug Administration regulations are required to show that the calculations produced in programs like MoreSteam's EngineRoom software are accurate, precise, and reliable, a process known as validation. This summer, MoreSteam has rolled out all the necessary resources to drastically simplify this process in the form of a validation kit.

This kit, available at no additional cost to EngineRoom users, has all the information to verify that the software's calculations square with those produced by a third party, in this case the National Institute of Standards and Technology. In the kit, you'll find information on MoreSteam's software development processes, datasets that can be plugged into EngineRoom for the validation process, and images of results in EngineRoom for comparison. Having these data and images eliminates the need to manually complete the process.

Certain companies are subject to this requirement because of an FDA regulation that applies to instances "when computer or automated data processing systems are used as part of the production or quality system." EngineRoom's role as a digital data analysis tool for Six Sigma-based process improvement places it squarely within this requirement, which stipulates that companies using such programs have documentation of validation on hand.

With this new kit, the validation process is simple: Import the data sets as instructed and check the results against the results screencaps included in the kit.

Even for users not in industries subject to stringent regulations on food and drug products, the validation kit can come in handy, said Omar Mora, a MoreSteam partner who works with medical device manufacturers in Costa Rica through his firm Blackberry&Cross.

"With this kit, you can rest assured that your calculations will be accurate and your decision making won't be at risk," Mora said.