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FDA 21 CFR Part 11

Who is required to comply?
All pharmaceutical manufacturing companies and those doing business with said companies.


What is it?

The Food and Drug Administration enforced the Act beginning in 2000. The Act mandates that electronic records maintain a high level of safety and integrity in case of corruption or deletion.


What are the requirements?

The FDA 21 CFR Part 11 enforces that all electronic records have an audit trail that is time-stamped and provide a unique fingerprint. If changes are made to content, the security features in place must identify who modified the content and at what time. Electronic records must be retained in case of future litigation or reference.


What is the cost of non-compliance?

Heavy fines and loss of corporate reputation.


What is the significance of FDA compliance?

The FDA CFR 21 Part 11 Act provides measures and controls over corporate corruption or misrepresentation of information.