Part 11 “Add-on” Coverage to FDA Surveillance Inspections Shedding Light on Industry Gaps

FDA is getting a better handle on where industry is having problems applying Part 11 as the results from its “add-on” coverage of computer systems during routine surveillance inspections begin to emerge.

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The agency’s effort to better comprehend industry’s understanding and implementation of Part 11 and its supporting “scope and application” guidance was announced by the Center for Drug Evaluation and Research (CDER) compliance office last summer (IPQ “In the News” August 7, 2010).

The decision was made during the fall to make the assessment as part of already-scheduled surveillance inspections.  The inspections incorporating the extra Part 11 focus began in December.  In scope are domestic and international manufacturing and clinical operations.

FDA intends to use the inspection findings to help it assess whether/how its related regulations and guidance need to be adjusted.

At the DIA Annual Meeting in mid-June in Chicago, CDER Office of Compliance (OC) Project Management Officer George Smith explained that the inspections are “going to continue based on the scope and application guidance, with no foreseeable end date. We may keep this going for a while.  It will depend on what we see and how we want to respond to it.”

The OC official added that the agency will take “appropriate action” to enforce the requirements if the findings are significant.  “We are not just looking at these and not doing anything about them,” he stressed.  “If they are significant, they could be in the EIR (establishment inspection report), they could be in the 483, they could even be in a warning letter.”

[Smith’s update on the Part 11 assessment effort and related inspection findings and his explanation of common industry misperceptions about Part 11 are provided for subscribers here.  Nonsubscribers can purchase the full story for $195 by contacting Jonathan Trethowan (  For subscription/license information, click here.]