Validating Patient- and Product-Critical Workflows

This white paper outlines a validation framework for workflows in Life Sciences where clinical, customer, or treatment inputs dictate product configuration, manufacturing, fulfillment, or availability. It emphasizes the importance of treating these workflows as regulated value chains, highlighting that failures can lead to significant issues such as product quality concerns or patient impacts. The document details a validation strategy that includes mapping workflows, identifying critical data elements, and defining business rules. It also discusses common failure modes and the necessity of testing various scenarios to ensure compliance and operational integrity. Furthermore, it presents a managed delivery model that combines validation with software engineering to enhance process discipline, particularly for medical device and diagnostics firms. The paper concludes by stressing the need for continuous validation and the establishment of a regression baseline to maintain control over changing workflows.