Do you know about 21 CFR part 11?
This is the part of FDA regulation that sets the rule for using electronic records and electronic signature in the life science industry. It ensures data integrity, security and traceability. It’s compliance is crucial for:
Submiting electronic data to FDA
Using e-signatue in the place of handwritten ones
ensuring all digital system meet validation and security standard
It bridges the gap between technology and regulatry compliance, helping speed up approvals while protecting patient safety.
Yes this will give the patient a confidence that the data she /he given to the doctor is safe and secured and not shared with anyone about their medical treatment.
In an industry where accuracy, accountability, and safety are non-negotiable, 21 CFR Part 11 ensures that innovation doesn’t outpace compliance. By upholding high standards for electronic systems, it helps build trust not only with the FDA, but with patients and healthcare providers alike.