What is 21 CFR Part 11?
CFR 21 Part 11 is the part of Title 21 of the US Code of Federal Regulations that sets forth the US Food and Drug Administration( FDA) regulation of electronic records and electronic signatures( ERES ).
CFR 21 Part 11 is valid for what type of industry?
In the pharmaceutical, medical maneuver, biopharmaceutical and other manufactures the FDA necessitates reliable archival see of information. It is only applicable to companies that supply medicine to the North American market.
In Brazil, ANVISA has the same requirements. Be aware, because the expectation is that each requirement is written as a customer requirement( ERU ). ANVISA should not expect to see specific requirements in the Brazilian ERU such as: paraphernalium according to CFR2 1 percentage 11.
Within industries which areas should I apply CFR 21 Part 11?
Applies to records in electronic form that are created, revised, maintained, archived, retrieved or transmitted under any record requirements were put forward in FDA regulations.
What are the criteria for applying CFR 21 Part 11?
21 CFR Part 11 defines the criteria under which electronic records and electronic signatures are considered reliable and equivalent to data recorded on paper. Therefore, with the digitization of pharmaceutical manufactures, the FDA wants to ensure that data previously stored on paper, and now recorded in electronic arrangements, is as reliable as data recorded on paper.
Therefore, if a regulated companionship maintains” hard fakes” of all necessary records, these newspaper substantiates can be considered the official document for regulatory purposes, and the computer system is not within the scope of electronic records storage requirements. Nonetheless, be kept in mind that the validation of data transfer from electronic systems to paper has to be validated. In other texts, if you captivate data by electronic means and transfer them through engraving to paper, this movement must be validated. In situations where the transportation is manual, there must be a review of the data transfer by a second person.
In order for the “hard copy” produced from the electronic beginning to be the official document, it must be a complete and reliable copy of the electronic generator 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, follow some definitions described in the North American code.
Electronic signature
Electronic signature symbolizes a computer data compilation of any represent or successions of emblems implemented, chosen or authorized by an individual to be the legally binding equivalent of the individual’s handwritten signature.
Corresponds to our rubric. It is not legally equivalent to our full subscription.
closed system
It necessitates an environment in which access to the system is controlled by people responsible for the content of the electronic records that are in the system.
Digital signature
An electronic signature based on cryptographic methods of originator authentication, calculated using a set of rules and a define of parameters that allow you to verify the subscriber’s identity and data integrity.
It corresponds to our full manual signature.
electronic record
Means any compounding of text, graphics, data, audio, persona or other representation of information in digital form started, modified, maintained, archived, retrieved or distributed by a computer system.
Examples of paraphernalium that need to comply with CFR 21 character 11 because they store critical tone data.
BMS and or FMS- monitoring work for critical environmental constants( temperature, humidity, adversity, etc .). These methods place measurement and control data from production ranges. It is critical data for production and perhaps used in fault investigation,
Production management software and generation of reports relevant to batch release.
Electronic batch release software: these software accumulates data that served as the basis for batch release, hence critical data.
Examples of electronic paraphernalium that does not need to comply with 21 CFR duty 11 because it does not store data.
Equipment that the raw data is transferred to the paper and this is considered as a valid substantiate. Ex: pHmeter, offline thermometers, offline thermohygrometer and printers that are accompanied by a perception system.