What is CFR 21 Part 11?

CFR 21 Part 11 is that the Title 21 portion of the US Code of Federal Regulations that establishes US Food and Drug Administration (FDA) regulation of electronic records and electronic signatures (ERES).

CFR 21 Part 11 is applicable during which type of industry?

In the pharmaceutical, medical device, biopharmaceutical and other industries the FDA requires reliable archival control of data . it’s only applicable to companies that supply drugs to the North American market.

In Brazil, ANVISA has the identical requirements. Stay tuned, because the expectation is that every requirement is written as a user requirement (ERU). ANVISA doesn’t expect to see in Brazilian ERU requirements such as: equipment according to CFR21 part 11.

Within industries which areas should I apply CFR 21 Part 11?

Applies to records in electronic form that are created, modified, maintained, archived, retrieved, or transmitted, under any record requirements set forth in FDA regulations.

What are the standards for applying CFR 21 Part 11?

CFR 21 Part 11 defines the standards under which electronic records and electronic signatures are considered reliable and equivalent to paper recorded data. Therefore, with the digitization of pharmaceutical industries, the FDA wants to make sure that data previously stored on paper, and now recorded in electronic systems, is as reliable because the data recorded on paper.

Therefore, if a regulated company maintains “hard copies” of all necessary records, these paper documents could also be considered the official document for regulatory purposes, and therefore the computer system is not within the scope of electronic record storage requirements. However, stay tuned because the validation of knowledge transfer from electronic systems to paper has to be validated. In other words, if you capture data electronically and transfer it through print to paper, this transfer must be validated. In cases where the transfer is manual, there must be a review of the info transfer by a second person.

In order for the “hard copy” produced from the electronic source to be the official document, it must be an entire and reliable copy of the electronic source and companies must be careful to state in their procedures and quality documents that the “hard copy” ” or with manual data from the records is the official document.
For better understanding follows some definitions described within the North American code.

Electronic signature

Electronic signature means a computer data compilation of any symbol or series of symbols executed, adopted or authorized by a private to be the legally binding equivalent of the individual’s handwritten signature.
Corresponds to our rubric. It doesn’t legally equate to our signature in full.

closed system

It means an environment during which access to the system is controlled by persons responsible for the content of electronic records that are in the system.

Digital signature

An electronic signature supported cryptographic methods of originator authentication, calculated employing a set of rules and a set of parameters that allow verifying the subscriber’s identity and data integrity.
It corresponds to our manual signature fully .

electronic registration

Means any combination of text, graphics, data, audio, image or other representation of data in digital form created, modified, maintained, archived, retrieved or distributed by a computing system .
Examples of equipment that need to be CFR 21 part 11 compliant because they store critical quality data.

BMS and/or FMS – monitoring system for critical environmental parameters (temperature, humidity, pressure, etc.). These systems store measurement and control data from the assembly areas. it’s production-critical data and possibly used in fault investigation,
Production management software with generation of reports relevant to batch release.

Electronic batch release software: these software stores data that served because the basis for batch release, therefore critical data.