Computer System Validation (CSV) enables companies to validate, test, and formally document that a regulated computer-based system does exactly what it is supposed to do. This ensures that the process in which drugs and medical devices are manufactured is safe, accurate, robust and traceable. CSV aims to prevent errors, improve the efficiency of processes, reduce compliance risks and facilitate inspections by regulatory organs. This is the process that replaces handwritten signatures and paper records in environments that are highly regulated and affect public health and safety like pharmaceutical, medical device and veterinary industries.
Market Dynamics:
Increasing global demand for pharmaceutical products and a greater emphasis on patient safety, and an increase in digital health devices and software-based systems within GxP environments are the factors expected to augment growth of the global computer system validation (CSV) market over the forecast period.
However, varying regulatory standards across organizations and high cost are expected to hinder growth of the global computer system validation (CSV) market during the forecast period.
Key features of the study:
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