The FDA announced July 8 that it will “soon” begin conducting a series of “focused” inspections to evaluate industry compliance with and understanding of 21 C.F.R. Part 11, which sets criteria for electronic records, electronic signatures and handwritten signatures executed to electronic records. According to the announcement, the inspections will focus on Part 11 requirements relating to human drugs.

The FDA said it will conduct the inspections in light of the enforcement discretion described in an August 2003 agency guidance entitled “Part 11, Electronic Records; Electronic Signatures — Scope and Application.” In the announcement, the FDA said it “intends to take appropriate action to enforce Part 11 requirements for issues raised during the inspections that do not fall under the enforcement discretion discussed in the guidance.” 

The guidance sets out conditions related to validation, audit trail, record retention, record copying and legacy systems where the agency does not intend to take enforcement action. “Conversely,” the agency said in the announcement, “violations of Part 11 requirements that do not fall within the guidance’s discretion can lead to enforcement action to enforce compliance depending on the importance of the violation.”

Additional information on the announcement will appear in the August issue of Thompson Publishing Group’s FDA Enforcement Manual newsletter.