Is Structured Product Labeling (SPL) Covered under Part 11 Rules for Electronic Records?

Q: I’ve started to get involved in Structured Product Labeling (SPL) and other electronic methods for submitting documentation to the FDA. I tried asking this question to the Project Manager of SPL, but I didn’t get a confident answer. So I I’d like to get your insight.

As I understand 21 CFR Part 11, the whole life-cycle of SPL would be regulated under Part 11 because this is an electronic record created and then transmitted to the FDA. Am I correct to say that the creation of SPLs and their submission to FDA falls within the regulatory requirements of Part 11?

A: Yes, you’re correct.

The system used to create the electronic records for your submission would be an electronic record-keeping system, and the SPL records created would be electronic records. So Part 11 would definitely apply.

Even though the electronic records may be copies of other records, you are creating or modifying an electronic record and transmitting electronic records that FDA will use to make a decision regarding whether your drug should be allowed on the market and how that drug should be labeled.

[pullquote align=”right” cite=”” link=”” color=”” class=”” size=””]Part 11 was written to deal with the creation and submission of electronic records for drug submission and approvals.[/pullquote]

21 CFR Part 11 originally was written to deal with the creation and submission of electronic records for use in the drug submission and approval process, so the regulation definitely covers Structured Product Labeling and the creation of such labels.

Answered by Denise Dion, Vice President of Regulatory & Quality Services at EduQuest (18 years as an expert FDA investigator and as the co-editor of FDA’s Investigations Operations Manual). Denise also is an instructor for EduQuest’s FDA Auditing of Computerized Systems and Part 11/Annex 11 training class.


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