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USDM is often called upon for emergency remediation by anxious clients in the midst of validation projects which are in crisis, or with significant retrospective audit findings by regulatory or internal audit authorities. As quality and validation professionals, USDM consultants are struck by the similarities between such situations, which can often have been avoided with the application of fundamental accepted principles of project management, IT governance and validation methodologies. While not per se a regulated validated system, the recent very public example of the fate of the website shows how well intentioned but ill-informed, poorly managed or ad hoc processes can sink an otherwise very straightforward IT project, with horrific consequences for all stakeholders.

This white paper will help USDM clients understand the factors that commonly lead to what are perceived as problems with system validation, but in fact are often rooted in areas that are not nearly as visible or obvious as the failed validation test results.

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