Computer Systems Validation (CSV) is central to the life sciences industry. Apart from being a regulatory requirement as set out by various regulatory authorities and practices such as the FDA, EMA, GCP, GLP, GMP and all the Predicate Rules; CSV is also very important to implement because not doing so will result in costly consequences.
These can range from:
More than anything else, implementation of CSV is also important because it ensures that the data is accurate and the information, secure. Implementing Computer Systems Validation is also an important step in making sure that the organization restricts or prevents any loss of revenue from its main activities or from the CSV exercise itself. It also helps to thoroughly identify and close any gaps in the computer systems.
Getting CSV is very important
With all these uses of a CSV; it is imperative for life sciences organizations to understand how they can implement a CSV that is effective and compliant with domestic and international regulations. The CSV should ensure that the organization gets the most out of it while meeting regulatory requirements.
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