Title 21 CFR Part 11 Section 11.10 Is the regulatory code for Electronic Records, specifically as it relates to the Controls for Closed Systems. According to the code, anyone who uses a closed system to create, maintain, modify, or share electronic records should use controls and procedures that are capable of ensuring the integrity, authenticity, and confidentiality of those records. This allows that the signer will not attempt to refute the records and that they can be confirmed as valid, compliant, and legal.

What Section 11.10 Means

The basic premise of this code is that organizations using electronic records must have procedures in place and documentation of those procedures to ensure that everything is authentic, confidential, and irrefutable and that the integrity of the document or process is maintained throughout. For 18 years, eLeaP has provided a validated platform for organizations in the life sciences industry.  Try a free sandbox account for 30 days and see how so many have benefited from our expertise.

This requires special rendering of electronic records and using storage tools that are compliant with CFR Part 11, as well as providing an audit trail that allows auditors to see the records in a format that humans can understand. Other important areas include:

• Document Storage and Record Retention: You need to have proper methods in place for storing documents and keeping them readily available until you need them again while still keeping them secure.
• System Access: You must ensure that only the right people have access to your systems as necessary for their job roles and maintain the utmost security.
• Workflows: It will be critical to ensure that all electronic workflows function correctly and provide people with safe access that is compliant with the guideline.
• Authority Checks: This is how you will control or limit user access on a record level and a system level, allowing you to verify that users are authorized to be performing the functions they are attempting to access or that they have already completed.
• Device Checks: It will also be imperative to verify that all equipment being used for purposes within the guidelines of the regulations is properly functioning and secured at all times.
• Personnel Accountability and Qualification: An organization is responsible for ensuring that trained and qualified personnel are the only ones allowed to perform certain functions and that individuals are held accountable for their actions regarding electronic signatures and records.
• Document Controls: How your organization controls documents and their history of changes over time will be an important part of compliance, as well. You need to maintain and preserve the full history of every document to remain compliant.

The Full Text of Part 11 Section 11.10

From the FDA CFR, here’s what the regulation states in regard to the control and management of electronic records and signatures:

11.10

Persons who use closed systems to create, modify, maintain, or transmit electronic records shall employ procedures and controls designed to ensure the authenticity, integrity, and, when appropriate, the confidentiality of electronic records, and to ensure that the signer cannot readily repudiate the signed record as not genuine.

11.10b

The ability to generate accurate and complete copies of records in both human readable and electronic form suitable for inspection, review, and copying by the agency.

11.10c

Protection of records to enable their accurate and ready retrieval throughout the records retention period.

11.10d

Limiting system access to authorized individuals.

11.10e

Use of secure, computer-generated, time-stamped audit trails to independently record the date and time of operator entries and actions that create, modify, or delete electronic records. Record changes shall not obscure previously recorded information. Such audit trail documentation shall be retained for a period at least as long as that required for the subject electronic records and shall be available for agency review and copying.

11.10g

Use of authority checks to ensure that only authorized individuals can use the system, electronically sign a record, access the operation or computer system input or output device, alter a record, or perform the operation at hand.

11.100c

Persons using electronic signatures shall, prior to or at the time of such use, certify to the agency that the electronic signatures in their system, used on or after August 20, 1997, are intended to be the legally binding equivalent of traditional handwritten signatures.

(1) The certification shall be submitted in paper form and signed with a traditional handwritten signature, to the Office of Regional Operations (HFC-100), 5600 Fishers Lane, Rockville, MD 20857.

(2) Persons using electronic signatures shall, upon agency request, provide additional certification or testimony that a specific electronic signature is the legally binding equivalent of the signer’s handwritten signature.

Sections 11.2, 11.3, and 11.5 go on to further designate requirements for electronic signatures and electronic record storage in detail.

Open Systems

21 CFR Part 11 Section 11.10 is just for closed systems. There are separate compliance codes for open systems under Section 11.30. Open systems will be held to the same standards, so in addition to everything required for a closed system, there will be additional confirmation and security steps that need to take place. This is where the latitude comes in, often, as companies struggle to find the best way to get their systems in compliance based on their operations. It is often a joint effort between your life sciences organization and the software providers that you use.

The Bottom Line

In summation, CFR Part 21, Section 11.10, is responsible for outlining the use and storage of electronic signatures and records, including loss management procedures and preventive scans, to ensure only authorized access is granted through the system. This must also include proper compliance training for employees that are using electronic records and engaging in electronic signatures so that everyone is doing their part.

At eLeaP, we have the best solutions for your LMS needs, including fully compliant solutions that meet all CFR requirements and guidelines so that we can best serve your life sciences organization, no matter what you need. Contact us today to see how we can help you.

The FDA (Food and Drug Administration) is responsible for regulating Title 21, which involves CFR Part 11 and the laws surrounding data security for life sciences and medical device brands. The basics of these laws are pretty straightforward, but while a lot of organizations assume they’re in compliance, they could be missing the mark and not even realize it.

CFR stands for Code of Federal Regulation, which means Part 11 is a guideline, not a hard-and-fast checklist of requirements for compliance. Here’s what the regulation outlines, verbatim from the code itself:

• 10

Persons who use closed systems to create, modify, maintain, or transmit electronic records shall employ procedures and controls designed to ensure the authenticity, integrity, and, when appropriate, the confidentiality of electronic records, and to ensure that the signer cannot readily repudiate the signed record as not genuine.

• 10b

The ability to generate accurate and complete copies of records in both human readable and electronic form suitable for inspection, review, and copying by the agency.

• 10c

Protection of records to enable their accurate and ready retrieval throughout the records retention period.

• 10d

Limiting system access to authorized individuals.

• 10e

Use of secure, computer-generated, time-stamped audit trails to independently record the date and time of operator entries and actions that create, modify, or delete electronic records. Record changes shall not obscure previously recorded information. Such audit trail documentation shall be retained for a period at least as long as that required for the subject electronic records and shall be available for agency review and copying.

• 10g

Use of authority checks to ensure that only authorized individuals can use the system, electronically sign a record, access the operation or computer system input or output device, alter a record, or perform the operation at hand.

Essentially, compliance with Part 11 means that all of your electronic records and signatures meet the requirements set forth and can be regarded as having the same level of validity and authenticity as a hardcopy document or signature.

There’s also a lot more to it.

#1: It’s Not Automatic

You are in charge of the responsibility to comply with CFR Part 11. You’re also in charge of validating that compliance in software and hardware platforms that you use. If you are using cloud-based solutions, it will take a lot of the compliance risk off your hands and allow you to lay the responsibility mostly on the tools that you are using. You can also choose to partner with companies like ours that have validation tools to ensure that all of your software and electronic records meet FDA CFR Part 11 compliance.

#2: It’s a Software and Hardware Issue

The hardware that you are using for electronic records access and updating is just as important to check for CFR Part 11 compliance as the software tools that you use. This is often why some people elect to use cloud solutions that will provide all of the data security compliance without the heavy hardware or bulky server requirements. It’s a two-fold process and it’s one that you need to follow through with in every regard to maximize your own regulatory compliance. Essentially, companies must design and implement policies and procedures that provide full protection for electronic records as outlined in Part 11.

#3: There are Three Controls for Compliant Systems

As mentioned, no single system will guarantee compliance with this complex code. The technical aspect of things is covered by the LMS developer, so they should be capable of meeting the requirements in that regard. However, the administrative processes and procedures come from the organization. If they fail to hold individuals accountable or they have not created proper procedures and policies, the system won’t be in compliance even if the LMS creator has done their part. At eLeap, we know that in addition to our software, there are several ways we can help you move toward compliance with this system, no matter what type of organization you have.

#4: Electronically Stored Training Records

All of your training records that are stored electronically are subject to FDA CFR Part 11 compliance. They must also comply with Good Laboratory Practices, Good Manufacturing Practices, and Good Clinical Practices. Training records that need to be kept in compliance include course versions, course completion records, and exam records. This ensures version accuracy in training software and provides accurate tracking for training and knowledge retention. Although the majority of the responsibility for compliance falls on the life sciences company, the systems being used must also be deemed “fit for use”.

#5: Digital Signatures and Electronic Signatures are Different

Many people don’t realize that in terms of regulatory compliance, digital signatures are different than electronic signatures. A digital signature may include a passcode, biometrics, or an additional security key that provides that added layer of authentication. These are not the topic of discussion when it comes to Title 21 CFR Part 11—they’re already protected, validated, and properly encrypted.

Electronic signatures, on the other hand, are not. These are the very literal digital translation of a wet signature, with no other security or authentication attached to it. These need to be validated to ensure that compliance is met with Part 11, and they should fall within the best practices that were mentioned above. Those include:

• Unique logins for electronic records access
• System lockouts after too many incorrect passwords
• Inactive account lockout
• And more

Learning is Half the Battle

Life sciences companies would do well to establish a standard operating procedure (SOP) for dealing with CFR Part 11 compliance, as the law itself is quite vague and often left to much interpretation. Understanding this regulation and how it impacts business operations is critical for companies that want to make the most of their electronic records and documentation. When people have the right information, they can make more informed decisions about their next steps.

The team at eLeap can provide validation assistance and the tools that you need to ensure that your electronic records and signatures are in compliance with FDA CFR Part 11, including a robust LMS that can even help train your team on best practices for compliance in this area and more.

The Learning Management System has largely replaced one-on-one or one-on-multiple instruction in a traditional classroom-style setting. More commonly known to most as an LMS, this tool is one of many in your organization that needs to meet the requirements and compliance guidelines of Title 21 CFR Part 11, along with all of the other digital software that you are using. The process of transmitting and sharing digital data has sparked compliance debates for years, but the implications of CFR Part 11 make it easier for life sciences organizations to get on board and check themselves off the list.

All of the electronic records stored in your LMS fall under the guidance of this code. Those records will typically also need to comply with Good Clinical Practices, Good Manufacturing Practices, and Good Laboratory Practices, ensuring that they provide secure documentation and proper recordkeeping for life sciences companies.

In order to check your LMS for all Title 21 CFR Part 11 software requirements, here is a checklist that can help.

#1: Do I Have an Open or Closed System?

In setting forth the guidelines for compliance with Title 21 CFR Part 11, decision-makers must understand whether they have an open or closed system. There are rules that differentiate based on the type of system that you have, which is why this is important. A closed system is one in which the people who are responsible for managing the records also handle the network.

With an open system, the people who are responsible for the records do not control access to the general system. Thus, they will have to monitor their own software and records within the system rather than being responsible for the system itself. For example, a public cloud would be considered open, while a private cloud, like your business Learning Management System (LMS), would be considered closed.

The difference matters because the FDA differentiates how you can protect the information, restrict access, and avoid data theft or damage. With closed systems, it’s easier to manipulate these elements and guarantee that the data is secure and everything is in compliance. In fact, Part 11 directly states that:

“Persons who use closed systems to create, modify, maintain, or transmit electronic records shall employ procedures and controls designed to ensure the authenticity, integrity, and, when appropriate, the confidentiality of electronic records, and to ensure that the signer cannot readily repudiate the signed record as not genuine.”

#2: What Information Needs to be Captured?

Within the guidelines of CFR Part 11, electronic signatures require not only the name and date but also the meaning of the signature or why a signature was required in the first place. The code specifies that each electronic signature needs to include:

• The signer’s printed name
• The time and date of signing
• The purpose of the signature (review, approval, agreement, etc.)

As with the entirety of the Title 21 CFR Part 11 software requirements, all of this information must be presented in a human-readable form and an electronic record.

#3: Authentication of E-Signatures

As part of compliance with part 11, you must ensure that authentication is in place to confirm access to authorized users only. In addition to the printed signature and timestamp, the following ID combinations are suggested by Title 21:

• Signatures not based on biometrics will employ at least two distinct components for identification, such as a username and password.
• When multiple signatures in a document take place, the first will need all components, with all subsequent signatures only needing a single component that can only be executed by the signer.
• Electronic signatures must be used only by the genuine owners
• All signatures must be executed and administered in a way that ensures attempting to use another’s credentials will require the collaboration of two individuals or more

To confirm that these signatures are as valid and binding as traditional wet signatures, all organizations will be required to send e-signature disclosure letters to anyone utilizing them to confirm that they are equivalent to a legally binding handwritten signature.

#4: Do You Have Remote Access?

In order to establish proper safety and security protocols, the FDA requires that all systems have remote access by administrators so that you can instantly limit or completely interrupt access to your system when suspicion is raised, or unauthorized access is found.

The existing electronic authorizations must be revoked or deauthorized immediately and temporary or permanent replacements should be issued under the appropriate controls. This should happen as soon as possible to ensure security and compliance of the system, as well as the users who access it.

#5: System Scans and Proactive Measures

In addition to setting up a compliant system, it will also be crucial that your system proactively work to safeguard itself from unauthorized access or forged signatures. As a subsection of CFR Part 11, the use of these safeguards is required to detect and report unauthorized use to the appropriate parties.

It’s a tall order, but it can save a lot of trouble down the line.

Keeping Up with the Changes

Regulatory compliance with CFR Part 11 is what helps life sciences companies ensure that they are meeting FDA guidelines not just for day-to-day operations, but for the storage and long-term use of electronic records and data as a means to run the business. It’s a demanding list of requirements, but it doesn’t insist on as much as some would expect, such as the use of biometrics or digital encryption methods, as much as it focuses on making sure organizations find the best way to keep their records secure.

As a small or midsize business, you should choose an LMS and other tools that have been vetted for compliance with CFR Part 11, including software requirements and more. When you partner with eLeaP, you can trust that you’re getting a compliant tool that goes above and beyond to ensure that all electronic records and signatures are secure, accurate, and representable as valid, authentic documents.

Having an FDA 21 CFR Part 11 compliant learning management system can be the difference between strong performance and success versus negative FDA audit findings. If you are in the life sciences industry which comprises organizations such as drug makers, medical device manufacturers, biotech companies, biologics developers, CROs, and other FDA-regulated organizations, you must validated systems. Connect with an expert. Companies in pharmaceuticals, biotechnology, biomedical technologies, life systems technologies, nutraceuticals, cosmeceuticals, food processing, environmental, biomedical devices are required to strictly adhere to the 21 CFR Part 11 standard when it comes to record keeping especially electronic signatures.

eLeaP is a validated learning management system which compliance with Part 11. Here are some terms and definitions you need to understanding when it comes to Part 11 compliance.

21 CFR Part 11 is not new, and it has always been problematic for life sciences companies. To comply with those rules and regulations, you must be able to show incontrovertible proof that you are and have been following the mandates. There’s good news – the allowance of digital signatures and electronic records makes things at least somewhat easier. Of course, as with most federal regulations, the devil is in the details. That’s why we decided to look into what makes it into your 21 CFR Part 11 compliance checklist.

The bad news is that, even with a modern learning management system and other technology in place, it can still be challenging to ensure you’re doing things the right way. Our 21 CFR Part 11 compliance checklist will help. Note that this checklist is usable with multiple different types of systems, including choosing/implementing a learning management system. You can download the whitepaper “How to Prepare for a 21 CFR Part 11 FDA Inspection“.

Validation

• Has the system been validated?
• Can you determine invalid records in the system?
• Can you easily retrieve records for the duration of their retention?
• Is access to the system limited to only specific individuals?
• Is there a way to ensure that only authorized users can access the system, sign records, or make other changes?
• Does the system only allow data inputs from authorized devices?
• Is there documented training for system users?
• Do you have a written policy dealing with user accountability and responsibility?
• Is there a controlled solution for accessing system resources?
• Is the system’s data fully encrypted?
• Do you enforce the use of digital signatures?

Audit Trails

• Does the LMS automatically generate a secure, time-stamped audit trail? Does that trail include the date and time of entries, as well as actions users take, including deleting or modifying data?
• Do changed records still include previous information in a legible format?
• Is the audit trail fully available and accessible for the duration of the record’s storage time?
• Can the audit trail be reviewed easily? Can it be sent to the FDA as a copy?
• Does each audit trail include important information, such as:
• User ID
• Event sequence
• Original and new values/data
• Changelog
• Revision and change controls
• Does each signed electronic record include the signer’s name, date and time of the signing, and the reason for the signing?
• Is there a system in place to ensure that electronic signatures cannot be copied or otherwise falsified?
• Do you have a formal change control procedure in place?
• Does each individual have their own electronic signature?
• Do you have a policy in place regarding the re-use, re-issuance, or reassignment of electronic signatures?
• Do you require identity verification before assigning a signature to an individual?
• Do you have at least two types of ID verification components in each signature?
• Do you require the user to re-submit their password during a session?
• Do you have an automatic time out procedure in place?

Electronic Records/Copies

• Does your system accurately reproduce copies of electronic records?
• Can the system easily create copies of records for review or use by the FDA?
• Does the system export records in an established/widely used format, such as PDF or XML?

Retaining Records

• Do you have specific controls set to ensure that each combined identification code and password remains unique?
• Do you have a policy that requires a periodic review of identification codes and passwords?
• What is your procedure relating to passwords/ID codes if an employee leaves the company?
• Can you disable a code/password if it is compromised?
• Do you have a procedure for reporting unauthorized use attempts?

The information above is a rough guide to ensuring compliance with 21 CFR Part 11. However, if these are uncharted waters, it’s highly recommended that you work with an experienced partner. At eLeaP, we have years of experience developing Part 11 compliant LMS software and help ensure that your data is safe and secure in the cloud.

How Does an LMS Fit In?

The 21 CFR Part 11 compliance checklist above applies to all digital systems your organization uses where data might be compromised or that might allow an attacker/malicious software to access other parts of the system. Your LMS contains a wide range of sensitive information about your employees, certification information, career data, and much more. It is also connected directly to your HR software and likely dovetails with other software used daily within your business, whether you’re in pharmaceutical development, medical R&D, or hospital management. Given that, it’s critical that you have the right LMS in place and that it complies with the FDA’s requirements.

How Does an LMS Help?

Now that we’ve explored the 21 CFR Part 11 compliance checklist, we need to address a few questions, particularly as they relate to your company’s LMS. At eLeaP, we take data protection and authorized access very seriously. We’ve built our LMS from the ground up to ensure that it is completely in line with the FDA’s requirements and mandates. You don’t want to wait to receive a Form 483.

Our system is cloud-based and completely secured using best-of-breed encryption. We also require that electronic signatures correspond with user data, including mandating that an e-signature is provided before awarding a completion status. Our system can be configured to require password authentication at periodic points, and we’ll log accounts out after periods of inactivity to safeguard against unauthorized access. Other features and benefits of our LMS include:

• Guaranteed tracking of records and activities
• Full access to detailed audit trails
• The ability to generate custom reports as needed
• Continually updated electronic training records stored securely
• Three-step electronic signature process, including user ID, password, and reason for change/modification

All of our features have been extensively tested to ensure operability and compliance with the FDA’s rules, as well. Ready to find out just how well our LMS can support your learners? Contact us today to schedule a custom consultation.

If you represent a life science organization – whether that’s medical device manufacturing, pharmaceutical research, or hospital management – you must comply with pretty stringent FDA guidelines and regulations. While there are many hoops to jump through, few are as confusing or have created as much controversy as 21 CFR Part 11. Not entirely sure what 21 CFR Part 11 is, how it applies to your organization, or what you need to do to comply with those rules? It can be confusing, but we’ll shed some much-needed light on it in this post.

What is 21 CFR Part 11, Anyway?

21 CFR Part 11 is part of the larger 21 CFR (Code of Federal Regulations). This specific section of the code applies to electronic (digital) records and signatures. Specifically, it’s all about things like:

• How you store digital data in your system
• How users access digital data in your system
• What checks and safeguards you have in place to protect data
• What rules you have for digital signatures

Ultimately, this part of the federal code has several primary purposes. They are:

1. To ensure that digital records are managed safely
2. That consumer and business/organization data is protected from bad actors
3. That there is a system to enforce accountability and traceability in place
4. That there are rules in place regarding digital signatures
5. That digital records and signatures are as legally binding and trustworthy as their physical counterparts
6. That life science organizations are following the same rules when it comes to FDA regulations

Does 21 CFR Part 11 Really Apply to My Organization?

Yes, most likely. It’s incredibly rare for a business not to fall under this heading. If your organization stores digital records of any type for any reason, and the organization is subject to FDA oversight, then you must comply with the rules set out in 21 CFR Part 11. What does that mean for you, though? See if your organization must comply with Part 11.

The Requirements You Need to Follow

To comply with 21 CFR Part 11, you need to follow a few basic rules. Like all federal regulations, they’re written in legalese, so it can be hard to understand what the FDA’s asking of your organization. However, when you strip away legal terms and put those requirements in plain language, it becomes easy to see that they’re actually about making your life easier and don’t necessarily constitute a major headache when it comes to enacting them.

1. System Validation

First, you must validate all systems in use to “ensure accuracy, reliability, and consistent intended performance.” In plain language, that means you need to define how all of your systems should work together and then make sure that they work as intended. The right validated LMS can dovetail with your existing systems and, if tested fully by the developer, will not require additional validation.

2. Record Generation

Your system is required to have a search and index function to help make finding specific records easier and faster. The right LMS will provide that ability but also offer additional information, such as versions, final documents, who authored document changes, and other critical information.

3. Audit Trails

Accountability is of great importance to 21 CFR Part 11. The FDA states, “Use of secure, computer-generated, time-stamped audit trails to independently record the date and time of operator entries that create, modify, or delete electronic records.” Your system must track, record, and maintain audit trails that show who did what, when, and why. The right LMS will have this capability baked in by the developer.

4. Operational Controls

The right LMS will provide you with operational controls that help determine how documents are reviewed, who can review them, and that certain conditions are met before the documents are signed off on – such as administration verifying that a learner has completed lead-up material before they sign off on completion of the final part of a certification course.

5. Security Controls

You must have gated security in all systems. This might be something as simple as a unique username and password for each user. However, it can also include two-factor authentication, biometrics, and more. The right LMS will support any combination of security controls your organization requires for protection.

6. Digital Signatures

The FDA explains, “A digital signature is an electronic signature based upon cryptographic methods of originator authentication, computed by using a set of rules and a set of parameters such that the identity of the signer and the integrity of the data can be verified”. Digital signatures can be used in place of physical signatures, and the right LMS provides direct visibility and control over all digital signatures in the system.

7. Training

The FDA requires that all users have training in how the system works. The right LMS is uniquely suited for this, as it can provide a “how to use the system” training customized to different learner’s requirements and needs.

Is eLeaP Right for Your Organization?

Answering the question of what is 21 CFR Part 11 is not all that difficult. However, determining the code’s impact on your organization and your choice of digital systems is more daunting. A single misstep could mean facing penalties after an FDA inspection.

Finding the right learning management system can be challenging, particularly for organizations that fall under FDA oversight. 21 CFR Part 11 sets stringent requirements that must be met when it comes to all electronic records and signatures in the organization, and that includes learning management efforts. At eLeaP, we have exhaustively developed and tested our LMS to ensure that it is fit for your intended purpose and meets or exceeds all FDA requirements. Contact us today to schedule your custom consultation.

Technology has dramatically changed our world in the last few decades. Today, we depend on our mobile devices for access to everything from news to work-related documents. Communication spans the ether, and data is more valuable than cash. That is why organizations in the US 21 CFR Part 11 regime are required to have systems that support this highly technical and critical work.

While it’s a brave new world for life science companies, it’s also one that lends itself to information theft and cyber-attacks. The dramatic increase in security breaches in companies of all sizes is evidence that no business is out of bounds for attackers and hackers. For life science companies, this poses some unique challenges, which the FDA attempted to address in the US 21 CFR Part 11 – the US Code of Federal Regulations section that deals specifically with electronic records and electronic signatures.

Unsure how these regulations affect your company’s L&D efforts? Don’t worry; we’ll walk you through what you need to know. There’s a lot to cover, but we’ll hit the high points.

Does US 21 CFR Part 11 Apply in Your Case?

There are a few basic questions you can answer here to help plot a course forward.

• Does your company fall under FDA oversight?

If so, US 21 CFR Part 11 affects you.

• Does your company use a computerized learning management system or intend to do so?

If so, the US 21 CFR Part 11 applies to you. Still unsure, check to see if your organization is covered under 21 CFR Part 11.

What Does US 21 CFR Part 11 Do?

While the entirety of 21 CFR covers thousands of pages, Part 11 is pretty specific. It deals with electronic records and electronic signatures within the computerized systems your company uses. Because learning management systems fall under this heading, your LMS must comply with 21 CFR Part 11.

The basic thrust of Part 11 is that:

• Electronic records (data) should be protected.
• User access to electronic systems and the data contained in them should be restricted.
• All changes and access to information should be linked to electronic signatures that are as trustworthy and authoritative as handwritten signatures.

On the surface, it seems like 21 CFR Part 11 is placing additional burdens on life science companies. However, the truth is that these new rules empower you to begin moving to a paperless future by laying the groundwork for how electronic records must be stored, protected, and accessed. Without this rule, your business would be limited to dealing with physical records and hardcopy signatures.

How Does an LMS Meet Those Challenges?

It’s important to state in the beginning that some LMSs won’t be up to the challenge set by US 21 CFR Part 11. This applies to both in-house developed systems and older systems developed by outside parties. In order to comply with the FDA’s requirements, an LMS must have some pretty specific features and capabilities, including the following:

• Audit Trails: One of the major focuses for the FDA is accountability/traceability. Audit trails are the solution to this. Your LMS must track, record, and report absolutely everything.

Moreover, it needs to provide access to that information in a range of formats, including within the system itself (via the dashboard, for instance), through printable reports, and also through digital reports that can be copied and shared (such as a PDF shared with FDA inspectors). What should your LMS record and report? Here’s a brief overview:

• User progress
• User changes
• User course progression and exemptions
• Unauthorized access attempts
• All changes to data (sequential, with full connection to who made the change, when, and why)
• Sets of triggered events (moving to module B after completing module A, for instance)
• Attempted access from unauthorized IP addresses/devices
• Electronic Signatures: Electronic signatures are considered legally binding and the same as a handwritten signature. They are tied to a username and password specific to each individual user within the LMS and should include multiple components, including the date/time, action taken, and the username taking the action or making the change. Electronic signatures must be inextricably linked to all relevant user actions and should be clearly visible, even if someone else makes changes to the same data at a later point. This information should be part of the audit trail.
• Data Security and Password Best Practices: Your LMS should make it easy to protect the information it contains. It should provide you with the means to set user roles and permissions, restrict access to sensitive information to those who need access and no one else, to set which devices and IP addresses can access the system, and more. User passwords and usernames must be unique and should be changed regularly. The LMS should also offer additional functionality, such as requiring a user to re-enter their password during lengthy sessions and requiring a complete login between sessions (it shouldn’t remember them from session to session).

Putting It All Together

We touched on some of the most important considerations above when it comes to complying with US 21 CFR Part 11 and the FDA’s requirements for your LMS. However, there’s more that you need to consider. This is particularly true when it comes to modern learning management systems – cloud-based systems offer the flexibility that you need, but not all of them are validated and compliant with 21 CFR Part 11.

Sorting through your options, vetting the various LMS platforms out there, and finding one that works for your life science business and complies with FDA rules can be exhausting and time-consuming. At eLeaP, we’ve done all the legwork for you. Our LMS is fully validated, fit for use, and compliant with 21 CFR Part 11 mandates.

In addition, our cloud-based system offers the flexibility, scalability, and ease of use you deserve. You can even author your own training content (or use our vast, built-in library). Contact us today to schedule a custom consultation.

Learning management systems have advanced a great deal in recent years. They’ve evolved from clunky, proprietary systems to cloud-based options that offer a streamlined experience for learners, as well as numerous benefits for life sciences companies themselves. Of course, you might not be aware of the key benefits offered by a modern LMS, or by one that is compliant with FDA 21 CFR Part 11.

Why You Need an LMS in the First Place

Before we dive into the benefits offered by an FDA 21 CFR Part 11 compliant LMS, let’s explore why you need a learning management system in the first place. What are they all about? What can they offer to life sciences companies, such as pharmaceutical firms, hospitals, or biotechnology businesses?

An LMS is designed for one thing – to make training simpler. What kind of training? Mandatory corporate training is one of the most commonly needed types. This includes things like sexual harassment training, workplace diversity training, and the like. However, that’s just the tip of the proverbial iceberg. For life sciences companies, a solid LMS can offer additional capabilities, including:

• The ability to develop leaders from existing employees
• The ability to promote from within and strategically plan hiring
• The ability to upskill employees and close skills gaps
• The ability to help employees earn additional certifications

It’s really all about enabling new advantages that can propel your business forward by investing in your current workforce and strategically planning your hiring. So, given that information, what benefits can an FDA 21 CFR Part 11 compliant LMS deliver? Let’s take a closer look.

The Critical Benefits of an FDA 21 CFR Part 11 Compliant Learning Management System

You’ll find a wide range of important benefits offered by the right LMS, but some of the most important are highlighted below:

• Comply with stringent regulations via secure audit-trail and training record verifications – With the right LMS, you comply with both federal and international rules and regulations related to information security, data protection, and electronic signatures. Without that compliance, you’ll be in breach and could face serious ramifications.
• Manage everything under one digital roof – The right LMS will give you the ability to manage your courses, instructors, learner sessions, and individual learners at a granular level. You should have at-a-glance access to this information through an intuitive, easy-to-use interface that makes it simple to find the information you need and make adjustments on the fly.
• Streamlining the entire process – Learning management can be complicated in the extreme. However, with a compliant LMS, you can streamline the entire process, particularly when it comes to regulatory and job-specific job training. Not only does that help ensure a better learner experience, but it helps ensure that you’re in compliance with additional rules and regulations.
• Track certifications – Specific members of your team must be certified for their roles within the organization. Other learners may be charting a course to a higher position that requires certification. With the right LMS, you can track those certifications, determine who holds what and when that certification needs to be re-upped, who needs what additional certification-related training, and so much more.
• Manage your knowledge assets – Knowledge assets is a term that can cover a broad range of things, and for life sciences companies, tracking and managing those assets can be incredibly challenging. With the right LMS, you can more easily track and manage courses, quizzes, tests, videos, seminars, lectures, and more. It’s all about saving time and sanity while ensuring that not only are you complying with regulatory requirements, but offering your learners the best experience.
• Audit reports to make decisions – Making decisions related to upskilling, career advancement, and the like requires access to in-depth information. In older-style learning management systems, that information is often fragmented and hard to locate. With a modern LMS, you get audit reports delivered containing the most important information so you can easily made informed decisions and move your team forward.
• Pre-assign necessary training – Simplify your learning management process with the ability to pre-assign necessary training based on positions, career paths, upskilling requirements and more. This can take a great deal of the burden off LMS administrators who may have had to assign training based on an individual basis in the past.

The Bigger Picture

Ultimately, a learning management system should support training and education, and allow you to develop a strong, qualified workforce. The FDA’s requirements pertain to data safety and security within your system in order to help prevent data breaches and to mitigate the impact of cyberattacks. When choosing an LMS, it’s important to keep that in mind, as well as how the features and functions of the system will help support your learners in their development.

Moving Your Life Sciences Company Forward

As you can see from the information above, there are some very important benefits offered by an FDA 21 CFR Part 11 compliant LMS. However, it’s critical to understand that not all learning management systems comply with the FDA’s mandates. Yet others leave it to you to determine what must be done to ensure compliance – that’s additional time and attention that you’re taking away from core responsibilities.

At eLeaP, we offer powerful learning management solutions designed for today’s life sciences business. Our system is cloud-based, completely secure, and complies with all of the FDA’s requirements, helping to ensure that you’re able to protect data and stay in compliance. Contact us today to learn more, to schedule a consultation, or to begin your free trial!

While Title 21 CFR Part 11 is nothing new, it has continually presented significant problems to businesses in the life sciences industry. While some of those challenges were eliminated with the ability to use electronic signatures and electronic records, many decision-makers still have questions and concerns. In this post, we’ll answer some of your most pressing questions regarding Title 21 CFR Part 11 compliance.

Is My Organization Covered by Part 11?

If your organization is in the life sciences industry and is regulated by the FDA (subject to FDA oversight), then, yes, Part 11 applies to you. This includes pharmaceutical companies, biotech firms, contract research organizations, medical device manufacturers, and many more. Even if your company does not fall under FDA governance, you may decide that complying with Part 11 is in your best interests in order to manage things like electronic training records.

How Do I Know If I Have an Electronic Records System?

Any “electronic records” system must comply with all parts of Title 21 CFR Part 11. However, how do you know if your system falls under that heading? Does it store records in electronic format for access or use later? Do you use electronic signatures to access the system and/or documents stored within the system? In those cases, your system certainly qualifies. All of today’s learning management systems fall under this heading. We recommend the GAMP Approach to 21 CFR Part 11 Compliance course to help you navigate the FDA’s compliance landscape.

If I Have a Commercial LMS, Does the FDA Require Validation?

In most cases, yes. Complying with GxP rules as well as FDA mandates for how electronic records are handled is required in all environments subject to FDA oversight. The FDA also requests that companies validate any LMS to ensure that it is fit for use within that organization. Note that LMS developers may claim “fitness for use”, but this is not the same thing as being able to claim full compliance with Title 21 CFR Part 11. When considering LMS platforms, choose one that is fully validated.

Is My System Closed or Open?

The FDA makes a differentiation between closed and open systems. However, many decision-makers are unsure of the difference. The FDA defines a closed system as one in which the people responsible for the management or electronic records are the same ones that handle the network. An open system, on the other hand, is one in which the individuals responsible for electronic records do not control access to the system. So, a private cloud would likely be considered a closed system, while a public cloud would be considered an open system.

The FDA’s differentiation hinges on the ability to restrict access, protect information, avoid damage or data theft, and more. In an open system, the individuals responsible for the data would need to take additional steps to ensure Title 21 CFR Part 11 compliance.

Is There Compliance LMS Software on Offer?

No software is compliant with Title 21 CFR Part 11 on its own. The FDA looks at these as “whole systems”. That is, the software and hardware must both be considered to ensure compliance with rules and regulations. Therefore, no software developer can legally claim compliance because the software requires hardware in order to operate. The network on which the software is installed and operated would also need to be in compliance.

However, in a cloud situation, where the LMS is stored on the provider’s hardware, and accessed remotely, the LMS developer can claim compliance (assuming the system meets FDA regulations, of course). This is because the LMS and the underlying hardware are part of a package – you get access to the software through the provider’s hardware.

What Happens If I Don’t Comply?

You might be able to run under the radar for a little while. However, if you operate in an industry under FDA oversight, you will eventually be subjected to an inspection. When this occurs and the inspection team finds that you’re lacking proper controls over electronic records and verification, they will issue a warning (Form 483). This will detail the areas that you need to correct, and then you will have a specified amount of time to enact those changes and corrections.

Choosing the Right Learning Management System

As you can see from the information above, the right technology is vital for complying with federal rules and regulations. It’s important to understand that not all learning management systems automatically comply with Title 21 CFR Part 11. It’s also important to realize that some LMS developers may make it seem like their offering is compliant, but “fit for purpose” is not the same thing.

So, how do you ensure that you choose the right LMS? First, look for a cloud-based solution. There are several reasons for this. One of those is that you don’t have to worry about validating your own network and hardware, which can be a pretty onerous burden. Second, make sure that the LMS vendor not only says their offering complies with all Part 11 rules and regulations, but offers the tools and capabilities necessary.

An LMS for Modern Life Sciences Organizations

At eLeaP, we work with life sciences clients in a broad range of sectors. Our LMS is state of the art, cloud-based, flexible, and fully tested for compliance with Title 21 CFR Part 11. Our groundbreaking talent management tools for life sciences organizations can help you do more, build the team you need for success, and more, all in compliance with the FDA’s regulations.

We invite you to contact us today to learn more or to request a custom consultation on your needs.

Are you thinking about migrating to a new learning management system within your life science business? It’s a big decision for any company but is particularly challenging for pharmaceutical companies, biotech firms, medical device manufacturers, and other businesses that fall under the purview of the FDA. This 21 CFR Part 11 tutorial article helps illustrate the FDA’s requirements and how you can meet them (with the right learning management system).

The elephant in the room her is 21 CFR Part 11 – the part of the FDA’s Code of Federal Regulations that deals with electronic records and electronic signatures. Your LMS is a critical area for compliance, as training records are high up on the FDA’s list of priorities during an audit. You also need to ensure that you’re providing learners with the best experience and that you’re doing your best to safeguard digital data in your keeping.

So, how do you choose an LMS that’s compliant with those regulations? This LMS 21 CFR Part 11 tutorial will explain some of the considerations that you need to make when shopping around for a new learning management system. It’s not as complicated as you might think – we’ll even bump features against CFR requirements to help you better understand the situation.

21 CFR Part 11 Tutorial: Requirements and Features Explained

Help Is at Hand

As you can see from our LMS 21 CFR Part 11 tutorial, there’s a lot to consider when choosing a new system. Thankfully, we can help. Contact eLeaP today to learn more about our groundbreaking learning management system and to schedule a consultation.

Is your life science business’s learning management system compliant with the FDA’s most recent rules regarding electronic records and signatures? It can be challenging to tell. However, it’s critical that you assess your LMS and make an informed decision. CFR Part 11 testing of systems and processes is required for full compliance with the FDA’s standard.

If yours is like many other organizations in the wider industry, you’re already laboring under a heavy regulatory burden in determining if your other electronic systems are up to par. Our goal here is to make things simpler for you. We’ll explore 21 CFR Part 11 testing to determine if your LMS is compliant with the most recent regulations and rules as set out by the FDA.

Should an LMS Be 21 CFR Part 11 Compliance: Testing the Idea of a Disconnect

Not sure if your LMS must comply with 21 CFR Part 11? The answer is yes, it should. Any life science business must ensure that all of its electronic systems comply with the validation, auditing, electronic signature, and reporting mandates the FDA put in place, and that includes your learning management system. So, if your system is outdated and doesn’t provide the control and information access you need, it’s time to upgrade.

Can an LMS Help with Regulatory Compliance in Other Ways?

Yes, your learning management system can (and should) be a central part of preparing your workforce for 21 CFR Part 11 compliance. How might that work? Actually, it’s relatively easy to understand. With an LMS that allows you to author your own training content, it becomes simple to create lessons, modules, and even entire courses that speak directly to 21 CFR Part 11 rules and regulations as they apply to individual employee roles within the business.

It also becomes possible to create course content around proper information handling procedures, password hygiene, data security and protection, and even around company-wide processes, such as the procedure to follow if a mobile device is lost, how to deal with potential security breaches, and what to do in the case of a compromised electronic signature (username and password, usually).

How to Assess Compliance: 21 CFR Part 11 Testing tips for Your LMS

Given the importance of your learning management system, both to company-wide compliance with FDA rules, and for training employees and managing their training records, it’s vital that you have an LMS that’s up to the task. The only way to ensure that yours fits the bill is to do some assessing on your own. What should you assess? We’ll explore those things below:

• Is the LMS validated? If it was not validated prior to implementation, and the vendor does not offer any assurances of validation, you will need to go through the validation process yourself to make sure that the LMS is suited to your needs and “fit for use”.
• Does it offer electronic record inspection capabilities and the ability to protect your data? One part of 21 CFR Part 11 requires life science businesses to make training records available to FDA inspectors, which means the information must be shareable. Another critical consideration is the level of protection offered by the LMS. Is it possible for unauthorized users to access sensitive information?
• Are there clearly defined SOPs (standard operating procedures) in place that detail how the system is to be used? Do your employees understand those SOPs and follow them?
• What security precautions are in place? Does the LMS require every user to have a unique electronic signature? Does it regularly require learners to re-enter their password to move to new modules? Does it timeout after a period of inactivity and require the user to re-enter their credentials?
• Does your LMS create a robust audit trail that shows who made changes, when those changes were made, and why they were made?
• Does the LMS support versioning, allowing you to track which version of courses, modules, and tests users have completed, when they were completed, and when they might be out of date?
• Does the LMS automatically conduct device checks to ensure that all login attempts are from authorized devices only? Is there a procedure in place to handle unauthorized devices?
• Does the LMS support accountability and responsibility for each user regarding their actions within the system?
• Does the system provide you with strong controls for electronic signatures at all levels?
• Does the learning management system link electronic signatures to electronic records for accountability? Do those electronic signatures consist of multiple components, such as username/ID, password, change reason, timestamp, and date stamp?
• How does the LMS determine whether records are completed or incomplete? Does it automatically update administrators about incomplete or inaccurate records?
• How does the LMS handle things like user certification after course completion?
• Is original information kept intact even when the records have been modified by administrators so that all versions are clearly accessible and understandable?

Finding the LMS You Need

If you’re finding that the LMS used in your life science business doesn’t stack up, it’s critical that you make a change. As mentioned, training records are often the first stop on any FDA-led inspection, and if yours aren’t up to par, there could be significant consequences. Of course, finding a learning management system that complies with 21 CFR Part 11 regulations can be pretty challenging.

At eLeaP, we understand just how critical it is that you have a compliant LMS. Our system is fully validated and guaranteed to be compliant with 21 CFR mandates. It also offers the best of modern technology, mobile accessibility, and the ability to author your own content if you so desire. Contact us today to schedule your custom consultation.

21 CFR Part 11 discusses compliance requirements for companies and organizations within the life sciences industry. This includes pharmaceutical companies, biotech firms, medical device manufacturers, medical manufacturing companies, and numerous others. Specifically, Part 11 deals with electronic records and electronic signatures used within any electronic system in those businesses. You can download the whitepaper, “How to Prepare for a 21 CFR Part 11 FDA Inspection“.

Because of that, it touches on your learning management system, as well as all of your other electronic systems (payroll, labeling, etc.). What does it mean for you, though? We’ll walk you through some of the most critical considerations to make, so whether you’re compiling a 21 CFR Part 11 PPT to share with your C-suite or simply need some guidance on migrating to a new LMS, you’ll have the information necessary.

What Is an Electronic System?

We’ll start with the basics. What’s an electronic system? The FDA doesn’t specify any particular type, but it applies to any type of computerized system where records are stored and accessed. Both closed and open systems are covered, and 21 CFR Part 11 applies equally to in-house networks and cloud-based solutions.

What Does 21 CFR Part 11 Require?

We’ll delve into the actual requirements shortly, but to provide a 10,000-foot view, the goals of these requirements are as follows:

• Access to data must be restricted
• Sensitive data must be protected from prying eyes, hackers, and malicious software
• The ability to alter information in any way must be controlled and restricted
• Full accountability, traceability, and transparency should be the rule

For most companies, your LMS should already provide at least some of that functionality. For instance, if your learners have to log into the system using a unique username and password, that constitutes two of the three components of an electronic signature. If your LMS saves and stores information about the courses, modules, and lessons your learners have taken and completed, those are “electronic records” and they’re vital to protect and store safely.

Why Does the FDA Care about Training Records?

One thing that might not be immediately apparent from browsing through a 21 CFR Part 11 PPT or checklist is why the FDA cares about your learning management and training records. It’s easy to understand why access to customer information should be protected. It’s also pretty clear why product labels should be linked to an electronic signature to ensure authenticity and trust. However, what’s the deal with your LMS?

First and foremost, training records are critical. They’re one of the first things an audit team will look at during an FDA inspection. Why? Because in the life science industry, the FDA requires that your employees be able to handle their responsibilities correctly and to understand their duties through in-depth training and development.

21 CFR Part 11 is all about ensuring reliable electronic records that can be trusted not to have been altered by anyone without authorization, and trustworthy electronic signatures that are carefully controlled and monitored. This applies to your learning management system as much as it does to any other electronic system in use within your organization.

The Four Key Features to Consider with an LMS

While a 21 CFR Part 11 PPT might make it seem like there are pages and pages of information that apply to your Learning Management System, the truth is that there are only four critical features that your system must-have. These are:

• Electronic signatures
• Versioning
• Auditing
• Reporting

Electronic Signatures

As mentioned already, electronic signatures are nothing more than usernames and passwords, combined with at least one other factor. Usually, at least when it comes to document alterations, this is a noted reason for the access and update. So, you need to ensure that your learning management system requires unique usernames and passwords, but also combines those with other factors including change reasons, time and date stamps, and more. The stronger the electronic signature, the more trustworthy it will be, and the greater the protection it will offer.

However, you cannot rely on the LMS alone for compliance with electronic signature rules. You also need policies and procedures in place that deal with things like ensuring the uniqueness of signatures across the organization, how to deal with lost/forgotten signature components, what to do when an employee leaves the company, and more.

Versioning

You must have control and the ability to document different versions when it comes to learning and development. For instance, if an employee completed a required module in the past, but a new version includes additional information that must be mastered, the LMS could alert you to the differences between the versions so that the employee could retake the module and ensure compliance. The versioning information could also be stored in the training record, providing insight at a glance as to which version the employee had completed in the event of questions.

Auditing

The ability to audit learning and development records is critical under 21 CFR Part 11. You should have access to any changes made to sensitive information, who made those changes, when they were made, and why.

Reporting

Like auditing, reporting is a vital consideration when choosing an LMS. You should have access to all of the information discussed above in easy-to-digest reports both within the LMS dashboard, and printable as hard copies. You should have access to exam/survey reports, compliance reports, certification reports, system reports, and more.

Why eLeaP Should Be Your Choice

Gaining important insights about the FDA’s requirements can be difficult, even with a detailed 21 CFR Part 11 PPT. At eLeaP, we designed our LMS from the beginning to ensure it is fit for your needs, making the validation process simpler and easier. From reporting and auditing to versioning and electronic signatures, our platform delivers both compliance and ease of learning. Contact us to schedule a custom consultation.