Overview of eLeaP’s Access Controls

Simplify how you manage user permissions within your LMS. eLeaP’s Access Controls automatically map access based on user roles, ensuring appropriate visibility and interaction privileges without the need for manual configuration.

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Access Controls for 21 CFR Part 11 Compliant Learning Management Solution for Life Sciences

Key Features

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eLeaP’s 21 CFR Part 11-compliant Learning Management System provides a comprehensive solution that harmonizes regulatory compliance with unparalleled learning experiences. Need GxP, Validation & Advisory services? For over 19 years, our platform has streamlined compliance efforts by integrating electronic signatures, robust audit trails, role-based access control, document management, and training record management.

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Why Use eLeaP’s Access Control System?

Automate the complexity out of user permissions with eLeaP’s intelligent access controls. Ensure security, comply with regulations, and streamline user management—all through an intuitive system that adjusts as your needs change.

Join many industry leaders who trust eLeaP to revolutionize compliance and learning management. Experience the synergy of regulatory compliance and enhanced learning outcomes with our 21 CFR Part 11-compliant LMS.

Platform Strengths

Discover the inherent advantages and standout qualities of the eLeaP 21 CFR Part 11 platform.

Organizations benefit from reduced compliance risks, significant time and cost savings through automation, enhanced data security, and personalized learning paths, ultimately ensuring regulatory adherence without compromising on the quality of learning experiences.

Life Science Industry

In the rapidly evolving life sciences sector, compliance and innovation are the pillars of success. For over 19 years, our 21 CFR Part 11-compliant learning management system has supported organizations in the industry. Here’s how:

  • Regulatory Compliance

    Comply with mandates using electronic signatures, audit trails, and role-based access control, ensuring adherence to stringent regulatory requirements.

  • Data Integrity Fortification

    Safeguard sensitive information with robust document management, ensuring secure storage and easy access to critical documents while maintaining data integrity.

  • Training Precision

    Tailor learning experiences to suit diverse learner groups, enabling comprehensive training records management for compliance reporting and audits.

  • Streamlined Operations

    Optimize workflows and reduce compliance risks with automated processes, enabling seamless integration and efficient management of learning resources.

  • Enhanced Security Protocols

    Elevate data security through stringent access controls, encryption measures, and continuous updates, fortifying your platform against potential threats.

Experience a transformative shift in the life sciences landscape with eLeaP’s 21 CFR Part 11 LMS, where compliance meets innovation and growth knows no bounds.

Why Choose eLeaP?

Understand the compelling reasons and unique advantages for selecting eLeaP as your learning solution.

We know you have choices when it comes to learning management systems or people success platforms. Here’s why hundreds of companies have selected eLeaP. Here’s a hint: it is because of the value they derive each and every day from the system and service.

Connect with an expert

Case studies: a track record of excellence

See the results of so many who have used the eLeaP system

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Overview of eLeaP’s Revision Controls

In highly regulated industries, managing electronic records with precision is not just best practice—it’s a requirement. eLeaP’s Revision Controls are specifically designed to meet the stringent requirements of 21 CFR Part 11, ensuring that every course revision is tracked, controlled, and compliant.

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Revision Controls for 21 CFR Part 11 Compliant Learning Management Solution for Life Sciences

Key Features

Get free sandbox account.

eLeaP’s 21 CFR Part 11-compliant Learning Management System provides a comprehensive solution that harmonizes regulatory compliance with unparalleled learning experiences. Need GxP, Validation & Advisory services? For over 19 years, our platform has streamlined compliance efforts by integrating electronic signatures, robust audit trails, role-based access control, document management, and training record management.

Get a free session with a solutions expert

Why Use eLeaP’s Revision Control System?

With eLeaP’s Revision Controls, you gain more than just compliance. Enhance course quality, improve content accuracy, and ensure that all training materials meet the current regulatory standards without additional overhead or complexity.

Join many industry leaders who trust eLeaP to revolutionize compliance and learning management. Experience the synergy of regulatory compliance and enhanced learning outcomes with our 21 CFR Part 11-compliant LMS.

Platform Strengths

Discover the inherent advantages and standout qualities of the eLeaP 21 CFR Part 11 platform.

Organizations benefit from reduced compliance risks, significant time and cost savings through automation, enhanced data security, and personalized learning paths, ultimately ensuring regulatory adherence without compromising on the quality of learning experiences.

Life Science Industry

In the rapidly evolving life sciences sector, compliance and innovation are the pillars of success. For over 19 years, our 21 CFR Part 11-compliant learning management system has supported organizations in the industry. Here’s how:

  • Regulatory Compliance

    Comply with mandates using electronic signatures, audit trails, and role-based access control, ensuring adherence to stringent regulatory requirements.

  • Data Integrity Fortification

    Safeguard sensitive information with robust document management, ensuring secure storage and easy access to critical documents while maintaining data integrity.

  • Training Precision

    Tailor learning experiences to suit diverse learner groups, enabling comprehensive training records management for compliance reporting and audits.

  • Streamlined Operations

    Optimize workflows and reduce compliance risks with automated processes, enabling seamless integration and efficient management of learning resources.

  • Enhanced Security Protocols

    Elevate data security through stringent access controls, encryption measures, and continuous updates, fortifying your platform against potential threats.

Experience a transformative shift in the life sciences landscape with eLeaP’s 21 CFR Part 11 LMS, where compliance meets innovation and growth knows no bounds.

Why Choose eLeaP?

Understand the compelling reasons and unique advantages for selecting eLeaP as your learning solution.

We know you have choices when it comes to learning management systems or people success platforms. Here’s why hundreds of companies have selected eLeaP. Here’s a hint: it is because of the value they derive each and every day from the system and service.

Connect with an expert

Case studies: a track record of excellence

See the results of so many who have used the eLeaP system

See all case studies

Audit Trails for Data Integrity Compliance

In regulated industries like pharmaceuticals, life sciences, and aviation, maintaining detailed audit trails isn’t just beneficial—it’s required. eLeaP’s Audit Trail Management ensures that your organization can easily monitor, verify, and audit training processes, making compliance straightforward and traceable at every step.

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E-signatures for 21 CFR Part 11 Compliant Learning Management Solution for Life Sciences

Key Features

Get free sandbox account.

eLeaP’s 21 CFR Part 11-compliant Learning Management System provides a comprehensive solution that harmonizes regulatory compliance with unparalleled learning experiences. Need GxP, Validation & Advisory services? For over 19 years, our platform has streamlined compliance efforts by integrating electronic signatures, robust audit trails, role-based access control, document management, and training record management.

Get a free session with a solutions expert

Why Use eLeaP’s Audit Trail System?

Our audit trails don’t just satisfy regulatory demands—they also offer insights into training effectiveness, pinpoint compliance gaps, and enhance the security of your training data. With eLeaP, you’re not just compliant; you’re a step ahead in the quality of your training and data management.

Join many industry leaders who trust eLeaP to revolutionize compliance and learning management. Experience the synergy of regulatory compliance and enhanced learning outcomes with our 21 CFR Part 11-compliant LMS.

Platform Strengths

Discover the inherent advantages and standout qualities of the eLeaP 21 CFR Part 11 platform.

Organizations benefit from reduced compliance risks, significant time and cost savings through automation, enhanced data security, and personalized learning paths, ultimately ensuring regulatory adherence without compromising on the quality of learning experiences.

Life Science Industry

In the rapidly evolving life sciences sector, compliance and innovation are the pillars of success. For over 19 years, our 21 CFR Part 11-compliant learning management system has supported organizations in the industry. Here’s how:

  • Regulatory Compliance

    Comply with mandates using electronic signatures, audit trails, and role-based access control, ensuring adherence to stringent regulatory requirements.

  • Data Integrity Fortification

    Safeguard sensitive information with robust document management, ensuring secure storage and easy access to critical documents while maintaining data integrity.

  • Training Precision

    Tailor learning experiences to suit diverse learner groups, enabling comprehensive training records management for compliance reporting and audits.

  • Streamlined Operations

    Optimize workflows and reduce compliance risks with automated processes, enabling seamless integration and efficient management of learning resources.

  • Enhanced Security Protocols

    Elevate data security through stringent access controls, encryption measures, and continuous updates, fortifying your platform against potential threats.

Experience a transformative shift in the life sciences landscape with eLeaP’s 21 CFR Part 11 LMS, where compliance meets innovation and growth knows no bounds.

Why Choose eLeaP?

Understand the compelling reasons and unique advantages of selecting eLeaP as your learning solution.

We know you have choices when it comes to learning management systems or people success platforms. Here’s why hundreds of companies have selected eLeaP. Here’s a hint: it is because of the value they derive each and every day from the system and service.

Connect with an expert

Case studies: a track record of excellence

See the results of so many who have used the eLeaP system

See all case studies

Part 11 e-Signatures Made Easy

At eLeaP, we understand the critical role of e-signatures in ensuring compliance, particularly in highly regulated sectors such as life sciences and aviation. Our e-signatures feature is designed to meet the stringent requirements set forth by regulations like 21 CFR Part 11, providing you with the necessary tools to streamline your training processes while maintaining compliance.

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E-signatures for 21 CFR Part 11 Compliant Learning Management Solution for Life Sciences

Key Features

Get free sandbox account.

eLeaP’s 21 CFR Part 11-compliant Learning Management System provides a comprehensive solution that harmonizes regulatory compliance with unparalleled learning experiences. Need GxP, Validation & Advisory services? For over 19 years, our platform has streamlined compliance efforts by integrating electronic signatures, robust audit trails, role-based access control, document management, and training record management.

Get a free session with a solutions expert

Why Use eLeaP’s e-Signature Module?

Integrate your compliance, training, and digital signing needs within one platform. This feature is designed to work seamlessly within the eLeaP LMS, eliminating the complexity of external e-signature solutions and enhancing your organization’s efficiency.

Join many industry leaders who trust eLeaP to revolutionize compliance and learning management. Experience the synergy of regulatory compliance and enhanced learning outcomes with our 21 CFR Part 11-compliant LMS.

Platform Strengths

Discover the inherent advantages and standout qualities of the eLeaP 21 CFR Part 11 platform.

Organizations benefit from reduced compliance risks, significant time and cost savings through automation, enhanced data security, and personalized learning paths, ultimately ensuring regulatory adherence without compromising on the quality of learning experiences.

Life Science Industry

In the rapidly evolving life sciences sector, compliance and innovation are the pillars of success. For over 19 years, our 21 CFR Part 11-compliant learning management system has supported organizations in the industry. Here’s how:

  • Regulatory Compliance

    Comply with mandates using electronic signatures, audit trails, and role-based access control, ensuring adherence to stringent regulatory requirements.

  • Data Integrity Fortification

    Safeguard sensitive information with robust document management, ensuring secure storage and easy access to critical documents while maintaining data integrity.

  • Training Precision

    Tailor learning experiences to suit diverse learner groups, enabling comprehensive training records management for compliance reporting and audits.

  • Streamlined Operations

    Optimize workflows and reduce compliance risks with automated processes, enabling seamless integration and efficient management of learning resources.

  • Enhanced Security Protocols

    Elevate data security through stringent access controls, encryption measures, and continuous updates, fortifying your platform against potential threats.

Experience a transformative shift in the life sciences landscape with eLeaP’s 21 CFR Part 11 LMS, where compliance meets innovation and growth knows no bounds.

Why Choose eLeaP?

Understand the compelling reasons and unique advantages of selecting eLeaP as your learning solution.

We know you have choices when it comes to learning management systems or people success platforms. Here’s why hundreds of companies have selected eLeaP. Here’s a hint: it is because of the value they derive each and every day from the system and service.

Connect with an expert

Case studies: a track record of excellence

See the results of so many who have used the eLeaP system

See all case studies

GxP Compliance Made Easy

At eLeaP, we specialize in guiding organizations to achieve and maintain GxP compliance, crucial for pharmaceutical and biotech industries. Our services span from detailed audits and gap analysis to developing bespoke GxP implementation strategies. Whether you’re a startup navigating initial compliance challenges or an established entity aiming to enhance product quality and safety, our expert team is equipped to support your journey towards regulatory adherence and operational excellence.

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GxP compliance services

5 Key Points

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Validation Services

Enhancing compliance through system and software validation

21 CFR Part 11 | Annex 11 Compliance Auditing, Gap Analysis and Recommendation Report
Lab Instrument Software Validation
BMS | EMS | LIMS | SAP | ERP | MES Validation
Cloud and IT System Validation Support
Excel Sheet Validation
Backup and Recovery Plans
Configuration Management
Supplier Audit Assistance

Validation Documentation Package
Development of Computer System Validation Master Plan (CS-VMP)
Development of Initial Risk Assessment (IRA)
Development of Functional Risk Assessment (FRA)
Development of Installation Qualification (including screen shots)
Development of Operational Qualification (including screen shots)
Development of Performance Qualification (including screen shots)
Development of Validation Traceability Matrix
Development of 21 CFR Part 11 Assessment Checklist (ERES)
Development of Validation Summary Report (VSR)

QMS & Medical Device Consulting

Tailored strategies to ensure compliance and operational excellence

eLeaP’s QMS Establishment Services offer comprehensive support for companies aiming to create and uphold a robust Quality Management System (QMS). We specialize in drafting Standard Operating Procedures (SOPs) for different departments, delivering personnel training, generating batch production records, conducting annual product reviews and trends analysis, initiating CAPA programs, and devising strategies for cross-contamination prevention, process validation, and cleaning protocols to ensure the highest standards of quality and compliance are met.

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Details of our QMS & Medical Device Advisory Services

We focus on five pivotal elements to elevate quality and compliance, ensuring your operations meet regulatory standards effectively:

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GxP Training

Training programs designed to empower your team to meet rigorous compliance standards

Organizations benefit from reduced compliance risks, significant time and cost savings through automation, enhanced data security, and personalized learning paths and progress insights, ultimately ensuring regulatory adherence without compromising on the quality of learning experiences.

Experience a transformative shift in the life sciences landscape with eLeaP’s learning solutions system, where upskilling and compliance meets innovation and growth knows no bounds.

Connect with an expert

Why Choose eLeaP?

Understand the compelling reasons and unique advantages for selecting eLeaP as your learning solution.

We know you have choices when it comes to learning management systems or people success platforms. Here’s why hundreds of companies have selected eLeaP. Here’s a hint, it is because of the value they derive each and every day from the system and service.

Connect with an expert

Case studies: a track record of excellence

See the results of so many who have used the eLeaP system

See all case studies

Learning & Development Analytics Made Easy

Progress Insights offer an advanced analytical tool that delves deep into the learning experiences of employees. It tracks not just completion rates but also engagement levels, providing a nuanced understanding of how learners interact with training materials.

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Progress Insights and Analytics

Key Features

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eLeaP’s Progress Insights, a part of the robust learning management system, provides powerful tools for engagement, upskilling, and regulatory compliance as various organizations position their team members for the future of work. With its detailed analytics and user-friendly interface, it’s an indispensable tool for organizations committed to nurturing a skilled and capable workforce. Get a free session with our experts to discuss how eLeaP can help. For over 19 years, our platform has streamlined skills development, credential management and compliance efforts by integrating learning paths, smart workflows, electronic signatures, robust audit trails, role-based access control, document management, and training record management.

Get a free 30-day trial

Benefits of eLeaP’s Learning Management System

Organizations seeking compliance and efficient learning management can benefit from the following advantages:

Join industry leaders who trust eLeaP to revolutionize compliance and learning management. Experience the synergy of regulatory compliance and enhanced learning outcomes with a comprehensive LMS.

Platform Strengths

Discover the inherent advantages and standout qualities of the eLeaP platform.

Organizations benefit from reduced compliance risks, significant time and cost savings through automation, enhanced data security, and personalized learning paths and progress insights, ultimately ensuring regulatory adherence without compromising on the quality of learning experiences.

Experience a transformative shift in the life sciences landscape with eLeaP’s learning solutions system, where upskilling and compliance meets innovation and growth knows no bounds.

Why Choose eLeaP?

Understand the compelling reasons and unique advantages for selecting eLeaP as your learning solution.

We know you have choices when it comes to learning management systems or people success platforms. Here’s why hundreds of companies have selected eLeaP. Here’s a hint, it is because of the value they derive each and every day from the system and service.

Connect with an expert

Case studies: a track record of excellence

See the results of so many who have used the eLeaP system

See all case studies

21 CFR Part 11 Compliant Learning Management System

Unlock the potential of seamless regulatory compliance and enhanced learning experiences with eLeaP’s 21 CFR Part 11-compliant Learning Management System (LMS). We have meticulously designed our platform to meet the stringent requirements set forth by the FDA, ensuring that your organization navigates the regulatory landscape effortlessly while fostering a culture of continuous learning and growth.

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21 CFR Part 11 Compliant Learning Management Solution for Life Sciences

Key Features

Get free sandbox account.

eLeaP’s 21 CFR Part 11-compliant Learning Management System provides a comprehensive solution that harmonizes regulatory compliance with unparalleled learning experiences. Need GxP, Validation & Advisory services? For over 19 years, our platform has streamlined compliance efforts by integrating electronic signatures, robust audit trails, role-based access control, document management, and training record management.

Get a free session with a solutions expert

Benefits of eLeaP’s 21 CFR Part 11 Learning Management System

Organizations seeking compliance and efficient learning management can benefit from the following advantages:

Join many industry leaders who trust eLeaP to revolutionize compliance and learning management. Experience the synergy of regulatory compliance and enhanced learning outcomes with our 21 CFR Part 11-compliant LMS.

Platform Strengths

Discover the inherent advantages and standout qualities of the eLeaP 21 CFR Part 11 platform.

Organizations benefit from reduced compliance risks, significant time and cost savings through automation, enhanced data security, and personalized learning paths, ultimately ensuring regulatory adherence without compromising on the quality of learning experiences.

Life Science Industry

In the rapidly evolving life sciences sector, compliance and innovation are the pillars of success. For over 19 years, our 21 CFR Part 11-compliant learning management system has supported organizations in the industry. Here’s how:

  • Regulatory Compliance

    Comply with mandates using electronic signatures, audit trails, and role-based access control, ensuring adherence to stringent regulatory requirements.

  • Data Integrity Fortification

    Safeguard sensitive information with robust document management, ensuring secure storage and easy access to critical documents while maintaining data integrity.

  • Training Precision

    Tailor learning experiences to suit diverse learner groups, enabling comprehensive training records management for compliance reporting and audits.

  • Streamlined Operations

    Optimize workflows and reduce compliance risks with automated processes, enabling seamless integration and efficient management of learning resources.

  • Enhanced Security Protocols

    Elevate data security through stringent access controls, encryption measures, and continuous updates, fortifying your platform against potential threats.

Experience a transformative shift in the life sciences landscape with eLeaP’s 21 CFR Part 11 LMS, where compliance meets innovation and growth knows no bounds.

Why Choose eLeaP?

Understand the compelling reasons and unique advantages for selecting eLeaP as your learning solution.

We know you have choices when it comes to learning management systems or people success platforms. Here’s why hundreds of companies have selected eLeaP. Here’s a hint, it is because of the value they derive each and every day from the system and service.

Connect with an expert

Case studies: a track record of excellence

See the results of so many who have used the eLeaP system

See all case studies

These days, information security is paramount. Life sciences companies, especially, face challenges in complying with the CFR Part 11 rule of Title 21. This rule is what sets forth the compliance guidelines for information security and electronic systems, and it is one that everyone needs to be familiar with in order to take their business to the next level.

Understanding this code and what it means to your organization is perhaps the biggest part of the compliance puzzle. Below, you’ll find all the details about the goals, methods, systems, and other factors.

With the software market for life sciences expected to see growth to as much as $22.5 billion through 2024, now is the time to get started. Get started on the right foot with the eLeaP validated platform.

CFR Part 11

The Goals of CFR Part 11

Despite the fact that this guideline was created all the way back in 1997, it still holds applicable use in the modern digital age and was designed to cater to the ever-changing needs of this industry with assistance like:

It’s also necessary for organizations to be more practical about how they manage paperwork across multiple offices or other multi-access needs. With today’s companies spread more globally and connected more remotely than ever before, paper-based systems just aren’t practical. Electronic records make far more sense and are far more efficient, but the challenge comes in proving to the regulating authorities that your system can handle the standards set forth by 21 CFR Part 11.

In doing that, and in learning more about this statute and how it may impact your organization, read on for five things you need to know about Part 11 and what it means to you. Also, feel free to connect with our CFR experts.

Digital Signatures and Electronic Signatures are Different

Title 21 CFR Part 11 is a very specific set of guidelines, and it explains carefully the difference between digital signatures, which aren’t monitored, and electronic signatures, which do fall under Part 11. Electronic signatures are those that are used to replace wet ink and are not validated with any kind of key or passcode or other digital authentication.

Digital signatures refer to those that are authenticated with another layer of security, such as a PIN number or password. These do not fall under Part 11 because of the two-factor authentication, but the electronic signature needs to meet all of the regulations of this compliance guideline.

Ask for Proof of Compliance Before Using Systems

In a perfect world, you would be able to take someone at their word when they tell you that they have the compliance tools that you need. When you’re looking at software that you can use for electronic signatures or records, you need to ask to see their proof of certification. Validating these systems is part of your due diligence in choosing the right solutions for managing and securing your data to meet Part 11 guidelines.

If you’re using SaaS (Software-as-a-Service) platforms, the vendor host and manager is going to hold more responsibility.

CFR Part 11 Compliance and FDA Compliance are the Same

If you’ve looked at software already, you may have noticed that some products are sold especially as CFR Part 11-compliant, but then there are others that are not marked as “FDA compliant” or otherwise validated. This is the same thing—whether it says “FDA” or “CFR,” the compliance is there. Of course, just because a provider claims that their software fits the bill doesn’t mean you should take their word for it. Ask to see their proof of validation so that you can guarantee their compliance before you choose their platforms.

It’s up to you to make sure that companies are compliant, as discussed above before you start working with them. By understanding the different terms and the way things are labeled, it will be easier for you to get what you need.

Not All Companies Have to Comply

While the majority of life sciences companies, including medical device and biotech brands, need to comply with Title 21 and the CFR Part 11 statute, not all companies will be subject to this regulatory compliance. In order to check to see whether you have to follow Title 21 CFR Part 11, you should consider whether you have any electronic records and take electronic signatures. If the answer is yes, the compliance is mandatory. Plus, you have to make sure that your hardware and software measure up, including if you’re using cloud-based or SaaS tools.

Electronic Signature Rules

In order to comply with 21 CFR Part 11, electronic signatures need to be captured in such a way that they are secure and password-protected whenever possible. Passwords need to be reviewed and approved regularly, and the guidelines of this statute even allow for a variety of electronic signature options:

Any and all of these secure methods can be used to allow both employees and clients alike to trust that they are being given a compliant process to deliver secure electronic records, no matter what area of life sciences they work in. The entire premise of this guideline is to establish security for electronic signatures, after all, so having the right tools is critical to your success.

It’s about regulatory compliance, but it’s also about protecting your organization. With CFR Part 11, the knowledge is half the battle, and once you know what’s expected, you can deliver the best electronic security compliance every single time. eLeaP is a validated software platform to meet CFR Part 11 compliance.

Life sciences organizations using electronic systems must check all of their software for CFR Part 11 compliance. Although many think otherwise, if the FDA requests an audit, it will not be of the software provider—it will be an audit of the life sciences organization using the software.

CFR Part 11 Software

When setting up electronic systems like an validated LMS, employee records database, or another laboratory platform or software solution, it is crucial for companies to work with solutions that are openly and obviously meeting the guidelines of CFR Part 11 software compliance, including as it relates to:

Software compliance is a topic that is on the rise, as it is expected that the life sciences software market will grow by as much as $2.55 billion through 2024. Software vendors are using SaaS-based models to enter new markets and expand their services, with cloud deployment that offers efficient, affordable, scalable solutions for all sizes and types of life sciences organizations.

Compliance is Not Inherent

CFR Part 11 software compliance is not guaranteed. Unlike some regulatory guidelines or standards, there is nothing preventing companies from launching SaaS products or other software solutions that are out of compliance with what the Part 11 mandate sets forth for electronic records and electronic signatures.

This is a standard that must be modified or added with intention. In some cases, users or developers can modify existing programs (such as Excel) to fit the guidelines of CFR Part 11 and other compliance codes. As of the time of this writing, however, most solutions do not automatically comply with CFR Part 11, nor do they guarantee it or even announce it very well.

What does that mean? Put simply, it means that it is up to your life sciences organization to choose compliant tools and ensure that you are capable of providing an audit trail and following the guidelines for electronic records and signatures.

So, What Do You Ask For?

When inquiring with software companies about their compliance and regulatory standards, you need to ask for proof of compliance with Title 21 CFR Part 11, as well as any other compliance standards that must be met. Companies should be able to produce this information to give you the peace of mind that you need. If they cannot, you should assume that the software isn’t compliant.

Ask companies if their tools meet the criteria for Title 21 CFR Part 11. These include guidelines like a need for clear audit trails, password protection and data security, and even electronic signatures and guidelines as to what does and doesn’t qualify as a legally binding signature. If a company doesn’t advise you as to whether their software meets compliance guidelines, you should always ask.

What Should You Get?

If you’re trying to make sure that you are protected under Title 21 and that your business is compliant, you are on the right track. This is your responsibility and even the software providers cannot be held responsible for your failures to confirm that all of your tools and resources are compliant.

When you are working with a company that will provide testing, validation, or supporting documentation, you will benefit in several ways. They should provide:

This should be done for all of the electronic software systems that are used, as well as for your network as a whole. Life sciences organizations need to ensure that every aspect of their software is in compliance with the CFR Part 11 software guidelines in order to operate legally and properly under the FDA’s regulatory guidelines.

A Note on Qualification

When you are qualifying or validating software and tools for their compliance, there are several different aspects that you need to consider. This statute was released in 1997, but it still delivers the basic language needed, so not much has been changed. The terms are transferable because even though they once referred to equipment, they can now be used interchangeably for software.

You’ll want to check three areas of qualification on all software when it comes to CFR Part 11 policy compliance:

The Rising Need for Operational Efficiency Improvements

In an industry that is expected to see so much growth, there is also a growing need for improvements in operational efficiency from an end-user standpoint. Through 2024, as life sciences software continues to enhance the performance of organizations, many companies depend entirely on this software to obtain information and create reports from them.

Another area where life sciences organizations can stand to make improvements is in the use of learning management systems (LMS). This software carries out the centralized training and management of employee data to aid in increasing compliance and operational efficiency. In turn, that will enable these organizations to remain competitive in their market.

The Software Market for Life Sciences: The Highlights

Through 2024, the life sciences industry will continue to see extensive growth in several areas, including electronic records systems and software tools used to perform everyday tasks. Upcoming trends and changes in consumer behavior will affect the changes taking place, while the growth of the competitive market landscape will provide a more secure set of solutions for the future of this industry.

As the industry continues to evolve and grow, the factors that challenge the market for software will also evolve. It will be up to the organization, not the vendors, to prove compliance in the event of an FDA audit. Nonetheless, it can benefit everyone if vendors start embracing compliance and delivering it as standard operating procedure like we do here at eLeaP. Contact us now to learn more about a custom, compliant LMS for your organization.

CFR Part 11 compliance is a huge issue for life science companies, and it’s important for everyone to be on the same page. How, though, can you make sure that your team truly understands the value of security in the digital age enough to follow the rules of CFR part 11 to the letter?

It’s a tall order, even for those who are familiar with the guidelines. However, it’s an essential part of your business and one that your team will need to comprehend and utilize in their day-to-day operations. That’s why it’s better to train everyone on data security and various tools used to provide the company with the protection that it needs.

CFR Part 11 Compliance

What is CFR Part 11?

For those who aren’t familiar, CFR Part 11 is a section of Title 21 that pertains to the securing and regulation of electronic records, including signatures, documents, data, and more. It’s a lot more complex than that, however, which is why you really have to figure out how to help your team understand it.

That starts by getting a firm grasp on the concepts yourself and fully understanding this statute and what is required by it. For example, if you have products on your own hardware, it’s your own responsibility to manage that software and to ensure that the proper procedures are in place in that regard.

CFR is the acronym for “Code of Federal Regulation”. The guidance in this code ensures the confidentiality, integrity, and authenticity of electronic data and signatures captured, and it’s important for all researchers to demonstrate that they have software and tools that are in compliance with the code.

Now, let’s talk a little more about what makes a tool or software platform compliant, as well as which features should be on the top of your list to discuss with your team.

Features to Consider for Part 11 Compliance

Although there are several different tools and software solutions on the market today, they are not all created equally. Many of them are compliant with Title 21 CFR Part 11 in every way possible, while others might lack the required compliance features for one reason or another. If you are going to invest in this kind of technology, you’ll want to consider things like:

Being able to validate the software and security that is being incorporated as part of electronic records is a big part of the process. It is going to be up to you to figure out what type of validation is required and how it can implicate the overall success of your data security, including electronic signatures and more.

While performing research and learning about compliance, brands are going to be able to check out the software solutions available and how they are hosted. It also helps people understand data and gives everyone the secure, compliant access that they deserve.

Evaluating Your Tools

With the guidelines set forth by the CFR Part 11 rule, there are several exceptions and things to consider when setting up the proper procedures and ensuring that all software is validated and documented as being the most efficient, straightforward tool for managing products and procedures in a digital environment. You should be looking for vendors and products that have procedures and solutions in place for things like:

When you use these criteria to explore the validation and compliance of Part 11 with the software solutions that you have in mind, it will be much easier for you to put these methods into practice and use your software and tech tools to provide data security solutions that fit the needs of your organization at this point in time.

Getting the Team on Board

Once you have taken the time to put yourself in a position to better understand Title 21 and CFR Part 11 compliance, you will be able to share the procedure and guidelines with your team. You should incorporate data security and digital or electronic signature integrity into all of your efforts and with the right tools, it will be easy to get everyone on the same page. Remember to talk to your team about the products and procedures that you have in place and help them better understand the value of integrity that comes with proper data security and compliance.

You’ll have different rules to follow and things to consider depending on whether you are using software on your servers, hosted cloud solutions, or any other kind of software tools. You will also need to let your team know that each of these elements is going to impact how you comply with CFR Part 11 and your organization’s overall procedures for managing that data.

It’s not a challenging effort, really. It’s more about being informed and understanding what this compliance means for your business and your digital efforts. When you take the time to engage everyone and share the responsibility of compliance with your team, you’ll have less trouble keeping everyone on the same page when you’re building your digital existence.

The CFR Part 11 summary essentially states that any data and electronic signatures used in business must be secure and comply with the FDA’s Part 11 statute guidelines. This means that a digital signature alone is not enough – it must be a physical representation of a wet signature and meet all of the necessary criteria to be legally binding and considered compliant.

In addition, all electronic records must be stored according to the regulation in a validated, secure system that has met all of the compliance markers set forth by the FDA in the code that was established in 1997. Life sciences organizations utilizing electronic systems for learning and training, data storage and record keeping, and other operations and functions will need to familiarize themselves with CFR Part 11 and how it impacts their business.

21 CFR Part 11 Summary

Does 21 CFR Part 11 Apply to You?

The first step in the process for any company is to determine whether this statute even applies to them and their digital efforts. Some companies will attempt to keep their “master records” on paper and then assume that means that they don’t have to worry about Part 11 compliance. In fact, that actually makes things much more difficult.

The FDA defines electronic records as:

“Any combination of text, graphics, data, audio, pictorial, or other information representation in digital form that is created, modified, maintained, archived, retrieved, or distributed by a computer system.”

Thus, according to the technical definition set forth, this offers broad coverage, which means that most companies will be affected today because they are doing business online and attempting to do so with digital signatures and other electronic information keeping.

The bottom line? Even if you have “paper” records, once they’re uploaded to a server, an email, or any computer system, you immediately enter the realm of Part 11 compliance.

Best Practices of Title 21 CFR Part 11

You can use these best practices to help check permissions, compare compliance solutions, and double-check all passwords and system security to provide the right access for the organization as a whole. Here are a few best practices that you will want to keep in mind:

Complying with Part 11 guidelines allows you to review and improve information for various processes and practices in your daily business. You may comply by providing solutions like:

Here again, digital signatures and electronic signatures are two different items entirely. Usernames should be individual and not associated with the team as a whole. You will also find the tools and software that you need to create your own process for checking compliance with 21 CFR Part 11.

You also can’t edit anything, or you’re going to have to go back to the formal approval rules that are in place. You also need to notify the FDA in writing that you’re going to be using electronic signatures so that they can properly monitor and audit your organization if necessary.

Validation and Qualification

Checking the infrastructure of the system will allow organizations to document qualifications and ensure that their electronic systems measure up to the requirements of CFR Part 11. Validation applies to software that comes from third-party vendors (SaaS, for example), computer systems, templates, and change controls. The hosting requirements and responsibilities are also different for SaaS/cloud solutions than for standard software or electronic databases.

Part of the qualification process will include coming up with a set of Standard Operating Procedures (SOPs) that can allow the organization to comply with all FDA regulations and other guidelines from an internal standpoint.

The Responsibility Falls to the Organization

Part of the guidelines of the Title 21 CFR Part 11 summary includes outlining the responsibility for compliance. This lies with the organization that is using the electronic systems or records, not the software provider or vendor. Vendors are held accountable to an extent, but when an FDA audit comes up, the organization will be the focus of the scrutiny. Since compliance with this guideline is limited to certain industries, the FDA leaves it as the responsibility of the life sciences organizations in question.

When you take advantage of the resources out there, you will be able to find assistance in compliance, including someone who can go through the checklist of compliance with Part 11 and then ensure that you are using an LMS, QMS, and other solutions that have passed compliance inspections and audits. That way, you are confirming that your tools are validated for installation, operations, and performance in terms of correct operation and regulatory compliance.

Partner with a team that understands the intricacies of Title 21 CFR Part 11 so that you can guarantee organizational compliance with all the tools and software that you use. When you choose eLeaP, you can start with your Learning Management System (LMS) and go from there to create the perfect custom solution for electronic record and signature compliance.

Title 21 CFR Part 11 is an important topic in the life sciences industry. As people are looking to build compliant solutions and keep their companies on track, understanding how to achieve those goals includes learning about the regulations and guidelines in place that are being held as the industry standard. In order to help more people better understand Title 21 CFR Part 11 and how it works, we’ve compiled a simple question-and-answer format article that will allow you to learn more about all of the most important aspects, one thing at a time. You can download the whitepaper “How to Prepare for a 21 CFR Part 11 FDA Inspection“.

21 CFR Part 11 Questions and Answers

What is Title 21 CFR Part 11?

Title 21 CFR Part 11 is the regulatory guideline that outlines provisions for electronic records and electronic signatures, including the management, creation, and regulation of them as well as what qualifies.

This outlines how electronic records can be created, stored, and shared, as well as what requirements exist for electronic signatures and which elements qualify as validating factors, including things like two-factor authentication and requiring a reason for any change that is made in the system according to CFR Part 11. Adhering to this statute can be confusing, so pay attention to the 21 CFR Part 11 questions and answers we raise here. You can also take a 30-day free trial of the validated eLeaP system and see how compliance can be simplified and effective.

Who does CFR Part 11 apply to?

This statute applies to several different industries, including life sciences and pharmaceuticals, as well as biotech companies and others. This regulatory statute applies to any organization within these industries that is looking to create secure digital or electronic records and use electronic signatures to do business online or in a digital environment rather than using hard copies.

How does Title 21 CFR Part 11 relate to GxP?

GxP, or the Good Practice Guidelines for multiple disciplines, define the ways that life sciences companies and other regulated organizations must control procedures, processes, people, and their premises to ensure quality and consistency in products and services.

The FDA’s Title 21 CFR Part 11 is just one facet of GxP compliance in the life sciences industry. Along with the FDA, the European Medicines Agency (EMA), the International Organization for Standardization (ISO), and the Medicines and Healthcare Products Regulatory Agency in the UK (MHRA) all refer to and define GxP in various publications.

What does GxP say about electronic records?

Under GxP, Part 11 is considered a Good Documentation Process, among other things. Data integrity is a critical component of GxP, including the guideline that if it hasn’t been documented, it didn’t actually happen. That is, organizations must specify, document, and accurately record every single critical action taken by an employee while involved in the creation, manufacturing, or delivery of a project or product. This is generally done with a Quality Management System.

What is considered an “electronic signature”?

An electronic signature is a digital version of someone signing their name in a legally binding way. Of course, this wasn’t always a perfect solution. There were several platforms and documents in the past that simply allowed people to type in their name or initials in place of an actual signature, attesting to the validity of whatever they were signing. This is not a secure method of doing things, though, so the FDA has stepped in and created a demand for a better solution.

Today’s electronic signature requires a username and password, along with a reason for the action taken on electronic records while logged in. For example, if someone logs into the LMS and retakes an exam they failed last time, the reason would be to retake the exam. Even if you just add an employee’s updated training status, a change must be noted as part of your electronic signature.

The idea is that not only will this keep data secure, but it will allow everyone within the organization to trace who made changes and when, as well as to keep tabs on the various actions and activities of others.

How do I know if the software is compliant?

The biggest struggle for many organizations is determining which tools are compliant and which ones are yet to be assessed. The software does not have to list that it meets compliance standards for CFR Part 11, so you might often find yourself having to ask. Some software does have compliant and non-compliant versions, but if you’re in the life sciences community, it’s best to default to buying compliant tools as much as possible so that you can stay ahead of the data security game. Check to make sure the software you are purchasing has undergone computer system validation. We know you might have more questions and need more answers regarding 21 CFR Part 11, so be sure to check out the quick definitions page.

If the software is reputable, it will generally do its part to ensure that you know that it is compliant with this standard and also that it is a transparent solution that will provide you with the resources that you need. If software balks at giving information about certification or if they seem to avoid the topic entirely, that is probably something that you should consider suspect.

Who is responsible for CFR Part 11 compliance?

Although software brands are responsible for creating products that fall within compliance guidelines if they wish to be used by life sciences companies, it is ultimately up to you to make sure that you are being compliant with CFR Part 11 and holding your team to a higher standard when it comes to data security and protecting your electronic records.

You should do your part to learn about this regulatory standard and what it entails, as well as what elements are going to be most important to your organization specifically. That way, you can focus your efforts and then focus on training people on the specific areas they need to know so you aren’t wasting time or resources.

What should I be training my employees on with CFR Part 11?

You’ll want to focus on proper training for username and password creation, ensuring that your company policies are in line with CFR Part 11 and that your SOPs are included in your LMS as part of onboarding and ongoing training.

You will also want to train people on:

With a proper LMS, it will be easy for you to implement training modules that cover all of these topics and more. Contact eLeap to discuss your needs and see how a validated software solution can help.