We recently discussed how Oracle’s safety system has the ability to produce ad hoc descriptive statistical reports on quality data. This brings us to the last rule we’ll discuss in our “Argus Safety for CAPAs” blog series.
This guide analyzes how artificial intelligence – including machine learning – can be used by pharmaceutical and medical device companies to improve the clinical data review and cleansing process.
System must comply with 21 CFR Part 11
How does Argus Safety support this rule?
Oracle’s Argus Safety is compliant with both the electronic record and electronic signature components of 21 CFR Part 11. However, it’s important to note that the system does not support biometric signatures, which are also governed by 21 CFR Part 11.