Originally Published MDDI October 2003NEWSTRENDS Erik Swain

Erik Swain

October 1, 2003

3 Min Read
FDA Limits Part 11 Scope

Originally Published MDDI October 2003


Erik Swain

FDA on September 5, 2003, finalized a guidance that narrows the scope and application of 21 CFR Part 11, which governs electronic records and signatures. The agency hopes it will address industry concerns about the cost of compliance and disincentives for using electronic records. But how industry will respond remains to be seen.

The guidance does not do away with the regulation, but it does confirm that the related draft guidances suspended in February will not be reissued, and it states that modifications to the regulation itself are imminent. The revoked draft guidances covered validation, time stamps, maintenance of electronic records, electronic copies of electronic records, a glossary of terms, and a compliance policy guide. The guidance also lifts Part 11 requirements from systems operational before August 20, 1997, in most cases.

The guidance clarifies that Part 11 applies only to electronic records used in place of paper, and not to electronic files merely used to generate official paper copies. Records that are relied upon for the performance of regulated activities and that are kept electronically in addition to on paper are also subject to the rule. Electronic signatures intended to be the equivalent of other official signings are also governed. 

The agency states that decisions about whether to validate computer systems, and to what extent, should depend on what impact the systems have on the ability to meet predicate rules. Similarly, it says the decision on whether to apply audit trails should be based on the need to comply with predicate rule requirements. 

“We believe that. . . broad interpretations could lead to unnecessary controls and costs and could discourage innovation and technological advances without providing added benefit to the public health,” the agency stated.

FDA did include a list of some specifics it intends to enforce, such as uses of operational system checks, controls over systems documentation, and the limiting of system access to authorized individuals. 

The new document is consistent with the agency's public statements this year. Valarie King-Bailey, chief marketing officer for Qumas (Cork, Ireland), said that in public appearances at conferences, FDA officials have been letting industry know that “for anything submitted to FDA, Part 11 is still required, and for anything governed by predicate rules, Part 11 is still required—if you choose to use electronic records. They want firms to use a common-sense approach. Provided you stick to your interpretation, and it's not far off, you'll be fine.”

Barbara Immel, president and chief executive officer of Immel Resources LLC (Petaluma, CA), questioned whether the move “sets a poor precedent. They have issued a guidance, which is not legally binding, suspending parts of a regulation, which has the force of law. They now say that computers used to generate paper records no longer have to comply with Part 11. But we all know that if both an electronic copy and a hard copy of a record exist, employees will always use the electronic version, whether or not there are sufficient controls to prevent unauthorized access or changes, people introducing errors, people writing over data, and so on.” The revisions may “take away a lot of the little things that were a concern for all the consulting companies that came in and created more work than necessary,” said Ran J. Flam, president and CEO of Sparta Systems Inc. (Holmdel, NJ). “But things like audit trails are never going to go away.” 

So, what may ultimately emerge is a Part 11 that is shorter on specifics.“It seems that the message is going to be ‘you take the risk, you tell us what needs compliance and what doesn't,'” said Joseph Vinhais, vice president of FDA regulations for Camstar Systems Inc. (Campbell, CA).—ES

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