New Concept Papers
The Role of Process Capability in Monitoring Product Quality: Monitoring Requirements and Self-Audit Continuous Improvement Opportunities
Process capability is not a regulatory requirement, but it is a supporting tool that helps organizations understand how a particular process is behaving and therefore, may be used to support product quality. For example, maximizing this ratio reduces risk to the patient, reduces the risk of drug shortages, and enables companies to provide products more reliably to patients around the world. Improving capability requires prioritization and a comprehensive understanding of the most important sources of variability in the process, excipients, raw materials, components, equipment, and supply chain.
Through understanding of this variability, action plans aimed at controlling and reducing variability can be implemented. This concept paper explores key considerations and challenges associated with implementation of process capability indices within the pharmaceutical industry.
Data Privacy: A Compliance Blind Spot
Clinical computerized systems, such as clinical trial databases, frequently process personal data, and thus require compliance with data privacy regulations. Controls required by data privacy regulations include encryption and restricted access, along with informed consent. Challenges associated with data privacy regulation include minimal clear guidance on requirements, often unclear scope of data privacy, and complexities associated with global footprints.
This concept paper aims to highlight where data privacy regulations could apply, and the requirements for computerized system implementation arising from those regulations. The data privacy principles described in this paper are condensed into tangible and meaningful actions with respect to clinical systems implementation. Case studies are provided to show real world examples of how privacy principles and regulations affect clinical systems.
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