21 CFR Part 11 compliance has to be adopted not just to avoid the wrath of the regulator, but also to ensure that data captured electronically is accurate and clean. With the widespread adoption of electronic systems to capture and record data has also come the risk of manipulation and loss.
This is the biggest risk for FDA regulated companies that rely heavily on accuracy of data in all processes – from clinical trials to production to customer complaint management. The important of Part 11 compliance can therefore not be stressed strongly enough – it’s not just the risk of warning letters that come with non-compliance, but consumer safety and the reputation of a company as well.
How Can FDA Compliance Training Help?
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