Rethinking Part 11: FDA Plays It Coy

Last December, after some delay, FDA began a project to better understand the industry’s adherence (or lack thereof) to 21 CFR Part 11 requirements. As such, the Agency is undertaking “add on” surveillance of manufacturers’ computer systems during the course of its regular inspections. At DIA 2011 in Chicago last week, FDA CDER’s George Smith, who heads up the Agency’s Part 11 working group, shared information on the status of these activities.

Smith acknowledged that the industry has struggled with Part 11, mainly in that the regulation (even after the 2003 Scope and Application document) has been broadly interpreted. Since its inception, he added, many manufacturers have incorrectly assumed that Part 11 applied to all electronic records, not just those that apply to FDA predicate rules. (Volumes of articles have been written to help the industry understand Part 11. Read our latest from consultant John Avellanet.)

Imperfect though it has been, Smith assured the audience that Part 11 is here to stay. “The Scope and Application guidance is still in effect and will remain in effect for the foreseeable future,” he said. “I’ve heard people say FDA is not inspecting for Part 11 compliance any more, and that is definitely not true.”


The work that began last December involves add-on “Surveillance Inspections”—that is, inspectors in the field gathering information about how Part 11 is being used within the industry. These inspections are being done within the course of regular, risk-based inspections. (“Remember, there is no such thing as a ‘Part 11 inspection’,” Smith said.)

What this effort is not, he noted:
• an “initiative”
• a survey or study
• additional scheduled inspections
• a report shared publicly (nothing formal will be provided)
• a standard approach for future Part 11 inspections

And the non-initiative has no end date. “We may keep this going for a while,” he said.

Next Steps?

What are the next steps? Smith wouldn’t say, but 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• Proposing new wording/language to existing CPGs (compliance policy guides for inspectors) and CPMGs that contain outdated interpretations of Part 11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

After Smith’s presentation, several industry consultants then weighed in. One of their key themes: the Scope and Application document should be withdrawn, replaced by something better.

--Paul Thomas