A CRO relies solely on paper-based record keeping citing fears of a data breach by a competitor. Is cleanroom data from this CRO submissible to the FDA?

Исследователь смотрит на пробирку с жидкостью

Yes. Despite the high risk for inaccurate transcription of values and fraud, 21 CFR 11 does not prohibit the use of handwritten or paper-based records. The goal of 21 CFR 11 is merely to enable the use of electronic records, not to require them.

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