A recent survey of the biopharmaceutical industry conducted by GartnerG2 indicates that the FDA could do a much better job of communicating the specific steps necessary to become compliant with the 21 CFR Part 11 regulation for electronic records submitted as part of drug applications.

The survey’s preliminary findings “reinforce the need for clear guidance from the FDA,” Gartner healthcare analyst Jonathan Edwards told BioInform. “There’s a lot of confusion about the regulation.”

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