Understand the factors that are perceived as problems with system validation, but are often rooted elsewhere.
USDM is often called upon for emergency remediation by anxious clients in the midst of validation projects that 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 be avoided by applying fundamental accepted principles of project management, IT governance, and validation methodologies. While not a regulated validated system per se, the very public fate of the healthcare.gov 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 customers 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.