The 9 Most Common Validation Problems

Frank Houston, EduQuest

What validation problems are you likely to see over and over? When tackling complex validation challenges, you’ll save time, money and headaches when you know the most common problems and where to find them. The following analysis is based on validation work EduQuest performed for a large FDA-regulated company over the past year. The goal was to bring the company’s software validation evidence up to the level of the U.S. FDA’s current expectations as well as those of the client’s own independent auditor. Our efforts yielded 1,720 observations.

As part of a “lessons learned” review, we categorized the observations and identified which documents contained them. The results – in our experience – are typical of the problems most companies face.

Thermal Validation: Measure Right for your Range

The AskAboutValidation Team

Economic pressures demand that operational inefficiencies be addressed and the highly regulated pharmaceutical industry is no exception. In past years, the need to ensure accuracy of measurement and documentation of data superseded any cost/time cutting methods. Inherent sources of inaccuracy had to be offset as best as possible, despite long, time-consuming methods meant to maintain accuracy and verify results. Thermal validation is a perfect example of this, with pre- and post calibration being de rigueur in mapping projects.

However, as improved technologies emerge, calibration of measurement devices is one area that can be made more efficient.

Typical calibration protocols specify pre- and post-calibrations. But, much of the associated expenditures in time and labor in thermal validation can be greatly reduced if the right tool is used. A more efficient approach to temperature mapping is to look at the temperature range to be mapped and use the most suitable instrument for that range, which allows pre- and post-calibration steps to be entirely eliminated.


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