21 CFR Part 11 Complete Companion:


Part 11

Medical device companies 21 CFR part 11 electronic signature that wish to vend their bias in the US and EU must apply a quality operation system that meets the conditions of 21 CFR Part 820.

We believe in “ right- sizing ” your quality operation system( QMS), allowing it to gauge with your company as you work through product development to establish supplier controls and a CAPA process, etc. But what are you going to do with all of that paper being generated as a result?

Medical Device Companies

numerous medical device companies can see the value of investing in a medical device specific elm’s that helps to bring your product to request briskly, and can make FDA examinations and ISO checkups go smoother; still, the added caveat is that these systems are subject to confirmation.

Specifically, 21 CFR Part 11 electronic signature, the FDA’s regulations for electronic attestation and electronic autographs. This regulation is extensively misunderstood and this confusion indeed causes some medical device companies to repel moving to electronic systems when they know it’s the right move.

Section of 21 CFR Part 11

In this comprehensive companion, we’ll take you through each section of 21 CFR Part 11, explaining what the conditions actually mean and expounding the most important points for you to know as a medical device company.

In conclusion, we’ll also punctuate many crucial features of Green light Guru’s elm’s platform and how those have proven to be necessary in helping medical device companies get to request briskly while remaining biddable with 21 CFR Part 11.

What’s 21 CFR Part 11?

In March of 1997, the United States FDA issued regulations that established the criteria for the acceptance by the FDA of electronic records, electronic autographs and handwritten autographs executed to electronic documents.

While our focus is on medical device companies and the compliance of their quality systems with this regulation, the rules also apply to companies in pharma, biotech, biologics inventors, and other FDA- regulated diligence. These laws are codified as Part 11 of Title 21 in the law of Federal Regulations, or 21 CFR Part 11, or Part 11 for longhand.

21 CFR Part 11 is divided into three sub-parts

The General vittles section discusses the compass of the regulations, when and how it should be enforced, and defines some of the crucial terms used in the regulations.

Electronic Records section

The Electronic Records section sets forth the conditions for administration of unrestricted and open electronic record- keeping systems, also discusses hand instantiations and conditions for establishing a link between autographs and records.

Eventually, the Electronic Autographs section is resolved into three corridor general conditions for electronic autographs, electronic hand factors and controls, and controls for identification canons watchwords.

Electronic Autographs section

Since its original publication, 21 CFR Part 11 has generated a significant quantum of confusion among medical device makers and other assiduity professionals that may use electronic records.

The FDA published a guidance document in August 2003 to clarify the compass and counteraccusations of colourful corridors of the regulations. This document also served to further interpret the conditions for software confirmation, inspection trails, managing heritage systems, keeping clones of records and record retention.

21 CFR Part 11 conditions

This document provides helpful information about what companies need to do in order to misbehave with its 21 CFR Part 11 conditions. With that said, it’s important to flash back that these kinds of guidance documents themselves aren’t the law and medical device companies should always relate directly to 21 CFR Part 11 when assessing their compliance status with FDA regulations.

Ten Chapters of 21 CFR Part 11

In this section, we’ll take an in- depth look into each section of 21 CFR Part 11 and pick out the most important points that medical device companies need to be apprehensive of.

Subpart a- General vittles

Sec.11.1 compass- This is the first section of 21 CFR Part 11 and its purpose is to establish what this regulation does and when it should be applied.

The regulations in 21 CFR Part 11 set forth the criteria under which the FDA considers electronic records and autographs to be secure, dependable, and generally original to paper- grounded records.

21 CFR Part 11 applies to records in electronic form that are created, modified, maintained, archived, recaptured, and/ or transmitted under any records demand set forth by the FDA.

21 CFR Part 11 operation

While there are some exemplifications listed of agency- needed records that aren’t subject to 21 CFR Part 11, quality operation records aren’t listed among the rejections then.

As soon as a medical device company uploads any part of their quality operation system to a computer, they’re subject to the conditions of 21 CFR Part 11.( And this is a little given fact that numerous paper- grounded companies aren’t apprehensive about.)


This section explicitly states that medical device companies can use paperless record- keeping systems if they’re in compliance with this regulation. For medical device companies who wish to transmit electronic records to the FDA.

They may do so if they misbehave with this regulation and if the attestation they wish to submit is linked in programNo. 92S- 0251 as a type of submission that the agency accepts in electronic form.


The FDA provides delineations for some of the language that will be used later in Part 11. One illustration would be the difference in delineations between unrestricted systems and open systems.

An unrestricted system is a record- keeping system where system access is controlled by persons who are responsible for the content of electronic records on the system. In an open system, access isn’t controlled by persons who are responsible for the contents of the electronic records on the system.

This language shouldn’t be confused with” open source” or other uses of” open/ unrestricted” as a descriptor. In this environment, an unrestricted system is one where the company keeps the records only on its own tackle and is accessible through its own internal network.

Leave a Reply

Your email address will not be published. Required fields are marked *