{"id":66893,"date":"2022-02-02T10:35:29","date_gmt":"2022-02-02T10:35:29","guid":{"rendered":"https:\/\/trainanddevelop.ca\/electronic-signatures-fda-part-11-and-how-to-comply\/"},"modified":"2026-04-29T12:11:43","modified_gmt":"2026-04-29T12:11:43","slug":"electronic-signatures-fda-part-11-and-how-to-comply","status":"publish","type":"post","link":"https:\/\/trainanddevelop.ca\/fr\/blog\/electronic-signatures-fda-part-11-and-how-to-comply\/","title":{"rendered":"Electronic Signatures, FDA Part 11, and How to Comply"},"content":{"rendered":"

\"\"<\/p>\n

The FDA 21 CFR Part 11 is a daunting piece of legislation but when viewed as a whole, we can see its goal is quite simple, to legitimize your digital records<\/span> by giving credence to electronic signatures, audit trails, and digital authority checks.<\/p>\n

We\u2019re here to summarize the jargon and arm you with practical options that will leave you FDA 21 compliant. Below we\u2019ve prepared an easy-to-read table on part 11 compliance. If that doesn\u2019t answer all your questions, the rest will.<\/p>\n

This is all based on our research and interpretation of the regulations. However, if there is any doubt when comparing this information to your unique needs, then we would suggest consulting a lawyer.<\/p>\n

Requirements for your FDA Compliance<\/h2>\n

If you are in an industry that deals with FDA regulations, you will be required to prove the authenticity of all your digital records under FDA 21 CFR Part 11. In many cases, an audit will need to be performed to confirm this. Compliance with FDA 21 CFR Part 11 is based upon your organization\u2019s ability to show procedures and controls that ensure:<\/p>\n

<\/i> Authenticity<\/span>
\n <\/i> Integrity<\/span>
\n <\/i> Confidentiality<\/span>
\n <\/i> Irrefutability<\/span><\/p>\n

When reviewing your compliance, you will notice there are some factors that relate to the software you use, and some factors that relate to the processes and personnel decisions you have in place.<\/p>\n

FDA 21 Part 11 Compliance Table<\/h2>\n

In order to comply with FDA CFR Part 11, you need to make sure your software or your operational systems checks can be traced, verified and audited if need be. This means if your software does not automatically track the whole part of the process, then you must provide a workflow, or operational system check<\/em> that records and provides the required data.<\/p>\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n
FDA Electronic Software System Compliance Requirements<\/center><\/th>\n
Your Software Needs to Handle<\/center><\/th>\n
Either Your System or Software Needs to Handle<\/center><\/th>\n
BIS Safety Software will Handle<\/center><\/th>\n<\/tr>\n<\/thead>\n
Computer System Validation<\/td>\n<\/td>\n<\/td>\n<\/td>\n<\/tr>\n
Record Rendering<\/td>\n<\/td>\n<\/td>\n<\/td>\n<\/tr>\n
Document Storage and Record Retention<\/td>\n<\/td>\n<\/td>\n<\/td>\n<\/tr>\n
Audit Trails<\/td>\n<\/td>\n<\/td>\n<\/td>\n<\/tr>\n
Workflows<\/td>\n<\/td>\n<\/td>\n<\/td>\n<\/tr>\n
Authority Checks<\/td>\n<\/td>\n<\/td>\n<\/td>\n<\/tr>\n
Document Control<\/td>\n<\/td>\n<\/td>\n<\/td>\n<\/tr>\n
System Access<\/td>\n<\/td>\n<\/td>\n<\/td>\n<\/tr>\n
Device Checks<\/td>\n<\/td>\n<\/td>\n<\/td>\n<\/tr>\n
Personnel Qualifications<\/td>\n<\/td>\n<\/td>\n<\/td>\n<\/tr>\n
Personnel Accountability<\/td>\n<\/td>\n<\/td>\n<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n

What the table above is depicting is the autonomous FDA part 11 compliance that is built into our health and safety software. Our software<\/a> will:<\/p>\n

<\/i> Export reports and documents in PDF format<\/span>
\n <\/i> Safely store data on a Closed<\/em> cloud<\/span>
\n <\/i> Preserve Audit Trails<\/span>
\n <\/i> Maintain an all-in-one solution, meaning the workflow is always in-sync<\/span>
\n <\/i> Maintain a hierarchy of physical locations and user roles<\/span>
\n <\/i> Stamp eSignatures with a date, time and unique user data<\/span><\/p>\n

Note:<\/strong> If your system is considered Open<\/em>, it may require additional procedures and controls. An Open<\/em> system is one where the user access is not controlled or restricted, or could also refer to a system that utilizes cloud storage that isn\u2019t restricted. For instance, google docs cloud storage could be seen as Open<\/em> depending on the access, whereas BIS system is closed because it requires administration clearance.<\/p>\n

Digital or Electronic Signatures<\/h2>\n

Electronic signatures that are obtained through software systems also need to follow strict record-keeping practices to ensure their accuracy:<\/p>\n

<\/i> eSignatures need to be forever linked to the respective records<\/span>
\n<\/i> They must include a printed name, date and time, and the meaning of the signature<\/span>
\n<\/i> Individuals signing must be confirmed by providing ID, and making sure their signature is unique<\/span>
\n<\/i> Adhere to specific design requirements for biometric (fingerprints) or non-biometric collection methods<\/span>
\n<\/i> Adhere to specific requirements for passwords and passcode-generating devices<\/span>
\n<\/i> And finally, you must inform the FDA prior to using electronic signatures <\/span><\/p>\n

How do you inform the FDA you\u2019re going to use electronic signatures?<\/span> Start by sending the FDA a Letter of Non-Repudiation Agreement.<\/em> Make sure this is consistent with your company\u2019s letterheads and signed with a handwritten signature. Provided your electronic signatures comply with everything above, you should have no problem getting approved.<\/p>\n

FDA 21 CFR Part 11 Explained<\/h2>\n

The Food and Drug Administration (FDA) is responsible for protecting American citizens by ensuring the safety of their food supply, pharmaceutical products, medical supplies, veterinary drugs, cosmetics, and products that emit radiation. (Yes, you read that correctly.)<\/p>\n

To respond to the changes in technology and the way that companies are collecting and sharing information about their customers, 21 CFR Part 11 was created. It refers to the authenticity of the electronic records collected and submitted to the FDA and has become one of their most (in)famous regulations.<\/p>\n

And it\u2019s confusing. Government regulations do not typically make for light bedtime reading. Is this regulation necessary?<\/p>\n

\n
\n

Why Is This So Important?<\/h2>\n

While it may seem like 21 CFR Part 11 was created to make your life more difficult, the intent is actually the opposite.<\/p>\n

The goal is to ensure that your electronic records and electronic signatures can be trusted.<\/p>\n

As digital record keeping becomes more and more commonplace and eliminates the use of physical hard copies for data, it is essential to protect the integrity and accuracy of your information. This regulation will help you with accountability and traceability of information throughout your documentation processes. It helps to protect against falsified records, unauthorized access to information, and ensures that everything is stored safely.<\/p>\n<\/div>\n

\n

\"\"<\/p>\n<\/div>\n<\/div>\n

This regulation deals with any submission of forms or information that is required by the FDA, specifically when they are made electronically. This is the heart of the regulation, so let\u2019s go over it again. All digital records that you are required to submit to the FDA for regulatory purposes are subject to Part 11.<\/span> This would include electronic forms used instead of physical forms, onsite inspections using a mobile device or tablet, and much more.<\/p>\n

FDA 21 CFR Part 11 Exemptions<\/h3>\n

You could be exempt from FDA 21 CFR Part 11 if you have a paper record and choose to scan and submit the record digitally. Or, if you use a software system to collect your information, and the system provides print outs which are used for submissions. Or finally, if you use legacy software that was implemented prior to August 20, 1997, again you may not be subject to Part 11.<\/p>","protected":false},"excerpt":{"rendered":"

FDA 21 CFR Part 11 summarized for the average user; we\u2019ve prepared an easy-to-read table and supply practical automated routes to electronic compliance.<\/p>","protected":false},"author":1,"featured_media":66894,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"om_disable_all_campaigns":false,"footnotes":""},"categories":[1445],"tags":[1491],"class_list":["post-66893","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-blog","tag-digital-forms"],"acf":[],"aioseo_notices":[],"aioseo_head":"\n\t\t\n\t\n\t\n\t\n\t\n\t\n\t\t\n\t\t\n\t\t\n\t\t\n\t\t\n\t\t\n\t\t\n\t\t\n\t\t\n\t\t\n\t\t\n\t\t\n\t\t\n\t\t\n\t\t\n\t\t\n\t\t\n\t\t