Regulations

Part 11 of Title 21 of the Code of Federal Regulations (21 CFR Part 11)

In 1997, the United States Food and Drug Administration (FDA) issued 21 CFR Part 11 to provide regulations for electronic records and signatures. This final ruling states that:

“[Electronic records and signatures] be trustworthy, reliable, and generally equivalent to paper records and handwritten signatures executed on paper.”

Then in 2003, the FDA released the Guidance for Industry: Part 11, Electronic Records; Electronic Signatures – Scope and Application. This guidance clarifies how Part 11 should be enforced, and the intended scope.

In 2015, the FDA released a Statistical Software Clarifying Statement. This document states that they do not require the use of any specific software for statistical analyses. But, the FDA requests that software package(s) be documented upon submission. This documentation must include version and build identification.

Conclusion

21 CFR Part 11 is not relevant or mandatory in the context of statistical analysis software itself.

However, when using R as part of a validated system, elements of 21 CFR Part 11 do apply.