Save or Scrap Part 11? Gregor Weighs the Options

Earlier this summer, we wrote about a talk by FDA CDER’s George Smith, the lead for the Agency’s 21 CFR Part 11 working group, regarding the “add on” surveillance of computer systems that FDA is now performing during the course of its regular site inspections. The point is to gather information about how Part 11 is being used within the industry.

Smith was noncommittal about whether the Agency might revise or even scrap the existing Part 11 regulation. He offered the following possibilities:

  • Keeping the status quo, plus publishing additional guidance focused on issues of concern
  • Amending the existing Part 11 regulation and/or preamble
  • Proposing new wording/language to existing CPGs (compliance policy guides for inspectors) and CPMGs that contain outdated interpretations of Part 11
  • Revoking the current Part 11 scope and applications guidance
  • Amending the current Part 11 scope and applications guidance

We asked industry consultant Michael Gregor, president of Compliance Gurus, to comment on the above options:

Status quo: “I would not recommend keeping the status quo, as it is clear that the industry has struggled over the years to interpret and apply Part 11,” Gregor says. “Furthermore, I think additional guidance will only further confuse industry.”

Amending the existing: “I agree. I think the new Part 11 should clearly detail what type of systems require Part 11 validation. Furthermore, a new Part 11 would need to detail the different record types subject to predicate rules, as this would help industry identify what records are required to be maintained.”

New wording/language to CPGs and CPMGs: “I think inspectors need to be better equipped with more detailed CPGs and CPGMs so there is no room for interpretation for FDA investigators,” says Gregor. “If the FDA could revamp its procedures, perhaps industry could receive more consistent interpretations of Part 11.”

Revoking: “I would not be opposed to this. The current guidance document has not helped the industry much. If it were to be eliminated, I honestly believe industry would not miss it. However, I do believe it would need to be replaced with a more detailed guidance document.”

Amending: “Amending the current Part 11 Guidance would not be a bad idea," Gregor says. "The current guidance does have some good content; however, it needs to be rewritten and amended to be more detailed so industry has something they could sink their teeth into."


--Paul Thomas

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