If you’ve spent time in pharmaceutical manufacturing or quality over the last year, you’ve probably heard someone say:
“CSV is going away.”
Not quite.
But the FDA’s Computer Software Assurance (CSA) guidance is clearly pushing the industry toward a different way of thinking about computerized system validation.
For decades, the default mindset around validation was simple: validate everything, document everything, and test everything. Read More >
CenPharma is a pharmaceutical consulting firm specializing in compliance, engineering and technical services. We specialize in designing and implementing systems in diverse areas such as method design, method transfer, quality compliance, quality assurance, inspection readiness, process validation, analytical method validation, equipment qualification, facility design, supplier qualification, environmental monitoring, quality management systems, learning management systems, materials management, auditing (hosting and conducting), compliance remediation, quality systems, investigation, root cause analysis, technical writing, change management, data integrity and quality control. Our team consists of experience pharmaceutical industry professionals with expertise in microbiology, engineering, compliance, system design and regulatory affairs.
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