FDA takes risk-based stance on Part 11 rule
Staff -- Manufacturing Business Technology, 12/1/2003 12:00:00 AM
Manufacturers in highly regulated industries have gained a little breathing room from the U.S. Food and Drug Administration (FDA) on the 21 CFR Part 11 rule, which governs electronic recordkeeping.
The regulations require makers of regulated products to follow specific controls such as audit trails when using electronic records and signatures. The regulations applied to users' legacy systems, as well as new ones they installed. While the FDA gave users several years to get up to speed on the regulations, during the past several years, it has begun enforcing them.
The new guidelines contain several provisions intended to clarify the regulations, and give users the ability to implement them in a "businesslike, quality-assurance type of environment," says John Blanchard, a principal analyst with IT advisory firm ARC Advisory Group, Dedham, Mass.
"Part 11 is alive and well with minor, but significant, changes," Blanchard recently wrote. "The first significant change is that the FDA will exercise enforcement discretion on most systems that were in operation before August 20, 1997—essentially, a conditional grandfather clause that the industry expected."
Blanchard notes, however, that grandfathering is conditional on the company having followed existing regulations for validation of paper and electronic records.
The second significant change is that the guidelines reinforce a risk-based approach so that Part 11 now applies only to systems involved in what are termed "high-risk" processes. "A system used for training typically is low risk, while systems that control batch process manufacturing would be considered high risk," Blanchard says.
The bottom line, he adds, is that the FDA has not changed direction on Part 11, "but it has allowed manufacturers to be proactive rather than reactive" in implementing the regulations.
Kathleen Waters, a principal automation engineer with Genentech, a biopharmaceutical manufacturer based in South San Francisco, agrees. Waters says she likes the clarification that the FDA has provided in several areas.
"For example, if you have a system that creates a paper record that's signed and stored—but generates an electronic version that's used for business purposes—then the electronic record falls under Part 11," she says.
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