The FDA's regulation for the use of electronic records and signatures

If your organization is required to keep records or make reports to the United States Food and Drug Administration (FDA), you need to understand the Code of Federal Regulations, Title 21, Part 11 (21CFR11). This regulation provides the criteria by which the FDA will accept electronic records and signatures as equivalent to paper records and traditional handwritten signatures. 21CFR11 establishes clear requirements for ensuring that electronic records and signatures are trustworthy and reliable.

The FDA purposefully allows organizations the flexibility to use a variety of technology and methods to meet the regulation; each organization must choose the most appropriate technology and methods to meet the regulation's requirements.

Benefits of electronic records and signatures

There are a number of important benefits that organizations can realize by using electronic records and signatures:

To what types of records does 21CFR11 apply?

The regulation applies to records required by a predicate rule. A predicate rule is an FDA regulation such as Good Laboratory Practice (GLP) or Current Good Manufacturing Practice (CGMP). Predicate rules mandate and define:

21CFR11 does not require organizations to use electronic records or signatures. Rather, if an organization voluntarily chooses to use electronic records or signatures to meet specific predicate rule requirements, 21CFR11 defines the requirements that must be met.

21CFR11 requirements

21CFR11 has a number of requirements. If a closed system (an environment in which system access is controlled by persons who are responsible for the content of electronic records that are on the system) is used to create, modify, maintain or trans

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Open systems

Open systems (an environment in which system access is not controlled by persons who are responsible for the content of electronic records that are on the system) require the same procedures and controls as for closed systems, plus document encryption and digital signatures as necessary and appropriate.

Signed electronic records

21CFR11 also requires that signed electronic records must include:

Electronic signatures

Requirements for electronic signatures include:

Upcoming changes

It is likely that the requirements of 21CFR11 will change in the next couple of years. In August 2003, the FDA released a guidance document stating that it "…will narrowly interpret the scope of part 11 and …anticipate[s] initiating rulemaking to revise provisions of that regulation." The FDA also stated that "…part 11 remains in effect during this re-examination period."

Implications for security managers

Organizations preparing to comply with 21CFR11 must consider a number of factors, including:

Conclusion

Increasingly, FDA-regulated organizations are using electronic records and signatures. They are doing so to save time and money or because their business partners are requiring it. Such organizations must have a strong understanding of 21CFR11 or run the risk of non-compliance.

About the author
Steven Weil CISSP, CISA, CBCP is senior security consultant with Seitel Leeds & Associates, a full service consulting firm based in Seattle, Wash. He can be reached at sweil@sla.com.