Key Features

• Electronic Signatures

  Ensure authenticity and accountability with secure electronic signatures, meeting 21 CFR regulatory requirements while maintaining traceability.

• Robust Audit Trails

  Track and record every action and access within the system, providing comprehensive audit trails for transparency and compliance.

• Role-Based Access Control

  Defined access levels based on roles, safeguarding data integrity, and ensuring confidentiality across the platform.

• Document Management

  Organize and manage documents securely within the system, facilitating easy access, revisions, and compliance with document control standards.

• Training Records Management

  Streamline record-keeping with centralized training records management, simplifying compliance reporting and audits.

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Why Use eLeaP’s e-Signature Module?

• Cost-Efficiency and Time Savings

  Streamline compliance processes and reduce manual efforts. Our platform automates compliance tasks, saving time and resources while reducing the risk of errors.

• Global Accessibility and Scalability

  Enable critical learning from anywhere, anytime. With a cloud-based infrastructure, our platform ensures worldwide accessibility and scalability, to accommodate your needs.

• Enhanced Training Effectiveness

  Elevate training effectiveness through interactive multimedia content, assessments, and real-time feedback, ensuring better knowledge retention and application.

• Improved Collaboration and Engagement

  Foster collaboration and engagement among learners through forums, discussions, and collaborative projects, enhancing the overall learning experience.

• Regulatory-Grade Security Measures

  Rest assured of top-notch security measures. Our LMS employs encryption, intrusion detection, regular security updates, and automatic back-ups to keep your data protected.

Key Features

• Comprehensive FAA-Compliant Training and Skills Management

  Meet FAA training and skills requirements for 14 CFR Parts 43, 91, 121, 135, and 145 with eLeaP’s platform. Track skills for pilots, maintenance, and ground crew. Manage recurrency training and validate competencies through On-the-Job Training (OJT) and skills assessments, keeping your team FAA-compliant and audit-ready.

• Centralized Document and Maintenance Control

  Securely manage and store FAA-required documents, such as maintenance manuals and operational procedures, in a centralized system. eLeaP’s document control features enable easy access, version tracking, and proper sign-offs for documents related to maintenance and safety operations, ensuring compliance with Parts 43, 121, and 145 standards.

• Robust Compliance Reporting and Audit Readiness

  Stay audit-ready with eLeaP’s real-time compliance reporting. Track every action—training completions, skills assessments, document updates, and maintenance records—to ensure full transparency. eLeaP’s audit trails simplify providing detailed reports during FAA audits, helping you meet compliance requirements for Parts 91, 121, 135, and 145.

• Role-Based Access and Data Security

  Ensure data integrity and protect sensitive operational data with role-based access control. eLeaP allows you to define custom access levels based on roles, ensuring that only authorized personnel can access or modify training records, skills assessments, maintenance logs, and compliance documentation, aligning with 14 CFR requirements for secure data management.

• Flexible Training and Skills Programs for Operational Excellence

  eLeaP supports Instructor-Led Training (ILT), Computer-Based Training (CBT), and On-the-Job Training (OJT) to ensure personnel meet required skill levels. For aviation industry clients, eLeaP delivers tailored training and skills management programs aligned with FAA compliance and operational goals, ensuring continuous improvement across Parts 43, 91, 121, 135, and 145.

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Benefits of eLeaP’s 14 CFR-Compliant Learning Management System

• Seamless FAA Compliance

  Ensure your organization meets the stringent requirements of 14 CFR Parts 43, 91, 121, 135, and 145 with ease, thanks to eLeaP’s comprehensive compliance management tools.

• Centralized Training and Skills Management

  Track and manage all training activities, certifications, and skill assessments in one place, ensuring all personnel maintain the required qualifications.

• Automated Recurrency and Certification Tracking

  Stay ahead of recurrency training deadlines with automated notifications and course assignments, ensuring continuous compliance.

• Robust Document Control

  Securely manage and track maintenance manuals, safety protocols, and operational documents with version control and audit logs, keeping you FAA audit-ready at all times.

• Customizable Learning Paths

  Tailor training programs for pilots, maintenance staff, and ground crew with role-specific learning paths that meet FAA standards and your organization’s operational needs.

Key Features

• Role-Based Access Control

  Defined access levels based on roles, safeguarding data integrity and ensuring confidentiality across the platform.

• Revision Controls

  Automatic documentation of all changes, including who made the change, what was changed, and when it was done to support thorough audits and inspections.

• Robust Audit Trails

  Track and record every action and access within the system, providing comprehensive audit trails for transparency and compliance.

• Electronic Signatures

  Ensure authenticity and accountability with secure electronic signatures, meeting 21 CFR regulatory requirements while maintaining traceability.

• Training Records Management

  Streamline record-keeping with centralized training records management, simplifying compliance reporting and audits.

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Why Use eLeaP’s Access Control System?

• Cost-Efficiency and Time Savings

  Streamline compliance processes and reduce manual efforts. Our platform automates compliance tasks, saving time and resources while reducing the risk of errors.

• Global Accessibility and Scalability

  Enable critical learning from anywhere, anytime. With a cloud-based infrastructure, our platform ensures worldwide accessibility and scalability, to accommodate your needs.

• Enhanced Training Effectiveness

  Elevate training effectiveness through interactive multimedia content, assessments, and real-time feedback, ensuring better knowledge retention and application.

• Improved Collaboration and Engagement

  Foster collaboration and engagement among learners through forums, discussions, and collaborative projects, enhancing the overall learning experience.

• Regulatory-Grade Security Measures

  Rest assured of top-notch security measures. Our LMS employs encryption, intrusion detection, and regular security updates, automatic back-ups to keep your data protected.

Key Features

• Revision Controls

  Automatic documentation of all changes, including who made the change, what was changed, and when it was done to support thorough audits and inspections.

• Robust Audit Trails

  Track and record every action and access within the system, providing comprehensive audit trails for transparency and compliance.

• Electronic Signatures

  Ensure authenticity and accountability with secure electronic signatures, meeting 21 CFR regulatory requirements while maintaining traceability.

• Role-Based Access Control

  Defined access levels based on roles, safeguarding data integrity and ensuring confidentiality across the platform.

• Training Records Management

  Streamline record-keeping with centralized training records management, simplifying compliance reporting and audits.

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Why Use eLeaP’s Revision Control System?

• Cost-Efficiency and Time Savings

  Streamline compliance processes and reduce manual efforts. Our platform automates compliance tasks, saving time and resources while reducing the risk of errors.

• Global Accessibility and Scalability

  Enable critical learning from anywhere, anytime. With a cloud-based infrastructure, our platform ensures worldwide accessibility and scalability, to accommodate your needs.

• Enhanced Training Effectiveness

  Elevate training effectiveness through interactive multimedia content, assessments, and real-time feedback, ensuring better knowledge retention and application.

• Improved Collaboration and Engagement

  Foster collaboration and engagement among learners through forums, discussions, and collaborative projects, enhancing the overall learning experience.

• Regulatory-Grade Security Measures

  Rest assured of top-notch security measures. Our LMS employs encryption, intrusion detection, and regular security updates, automatic back-ups to keep your data protected.

Key Features

• Robust Audit Trails

  Track and record every action and access within the system, providing comprehensive audit trails for transparency and compliance.

• Electronic Signatures

  Ensure authenticity and accountability with secure electronic signatures, meeting 21 CFR regulatory requirements while maintaining traceability.

• Role-Based Access Control

  Defined access levels based on roles, safeguarding data integrity, and ensuring confidentiality across the platform.

• Document Management

  Organize and manage documents securely within the system, facilitating easy access, revisions, and compliance with document control standards.

• Training Records Management

  Streamline record-keeping with centralized training records management, simplifying compliance reporting and audits.

Get free sandbox account.

Why Use eLeaP’s Audit Trail System?

• Cost-Efficiency and Time Savings

  Streamline compliance processes and reduce manual efforts. Our platform automates compliance tasks, saving time and resources while reducing the risk of errors.

• Global Accessibility and Scalability

  Enable critical learning from anywhere, anytime. With a cloud-based infrastructure, our platform ensures worldwide accessibility and scalability, to accommodate your needs.

• Enhanced Training Effectiveness

  Elevate training effectiveness through interactive multimedia content, assessments, and real-time feedback, ensuring better knowledge retention and application.

• Improved Collaboration and Engagement

  Foster collaboration and engagement among learners through forums, discussions, and collaborative projects, enhancing the overall learning experience.

• Regulatory-Grade Security Measures

  Rest assured of top-notch security measures. Our LMS employs encryption, intrusion detection, regular security updates, and automatic back-ups to keep your data protected.

Key Features

• Electronic Signatures

  Ensure authenticity and accountability with secure electronic signatures, meeting 21 CFR regulatory requirements while maintaining traceability.

• Robust Audit Trails

  Track and record every action and access within the system, providing comprehensive audit trails for transparency and compliance.

• Role-Based Access Control

  Defined access levels based on roles, safeguarding data integrity, and ensuring confidentiality across the platform.

• Document Management

  Organize and manage documents securely within the system, facilitating easy access, revisions, and compliance with document control standards.

• Training Records Management

  Streamline record-keeping with centralized training records management, simplifying compliance reporting and audits.

Get free sandbox account.

Why Use eLeaP’s e-Signature Module?

• Cost-Efficiency and Time Savings

  Streamline compliance processes and reduce manual efforts. Our platform automates compliance tasks, saving time and resources while reducing the risk of errors.

• Global Accessibility and Scalability

  Enable critical learning from anywhere, anytime. With a cloud-based infrastructure, our platform ensures worldwide accessibility and scalability, to accommodate your needs.

• Enhanced Training Effectiveness

  Elevate training effectiveness through interactive multimedia content, assessments, and real-time feedback, ensuring better knowledge retention and application.

• Improved Collaboration and Engagement

  Foster collaboration and engagement among learners through forums, discussions, and collaborative projects, enhancing the overall learning experience.

• Regulatory-Grade Security Measures

  Rest assured of top-notch security measures. Our LMS employs encryption, intrusion detection, regular security updates, and automatic back-ups to keep your data protected.

Key Features

• Comprehensive Training Platform

  Foster a culture of continuous learning, skill development, and knowledge retention that drive organizations forward.

• Regulatory Compliance Ready

  A regulatory compliance solution to help organizations mitigate risks and ensure compliance with relevant regulations.

• Engaging Learning Experiences

  Our learning solutions to enhance and optimize the learning experience, so its more interactive, engaging, and effective.

• Data-Driven Insights

  Use data, and analytics to align organizational goals and outcomes to make data-driven improvements and drive results.

• Training Records Management

  Streamline record-keeping with centralized training records management, simplifying compliance reporting and audits.

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Benefits of eLeaP’s Learning Management System

• Global Accessibility and Scalability

  Enable learning from anywhere, anytime. With a cloud-based infrastructure, our platform ensures worldwide accessibility and scalability, accommodating the needs of your growing organization.

• Enhanced Training Effectiveness

  Elevate training effectiveness through interactive multimedia content, assessments, and real-time feedback, ensuring better knowledge retention and application.

• Improved Collaboration and Engagement

  Foster collaboration and engagement among learners through forums, discussions, and collaborative projects, enhancing the overall learning experience.

• Regulatory-Grade Security Measures

  Rest assured of top-notch security measures. Our LMS employs encryption, intrusion detection, and regular security updates, automatic back-ups to keep your data protected.

• Tailored Learning Paths for Diverse Audiences

  Create personalized learning paths for different user groups, ensuring each learner receives relevant and targeted training.

Key Features

• Electronic Signatures

  Ensure authenticity and accountability with secure electronic signatures, meeting 21 CFR regulatory requirements while maintaining traceability.

• Robust Audit Trails

  Track and record every action and access within the system, providing comprehensive audit trails for transparency and compliance.

• Role-Based Access Control

  Defined access levels based on roles, safeguarding data integrity and ensuring confidentiality across the platform.

• Document Management

  Organize and manage documents securely within the system, facilitating easy access, revisions and compliance with document control standards.

• Training Records Management

  Streamline record-keeping with centralized training records management, simplifying compliance reporting and audits.

Get free sandbox account.

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

• Cost-Efficiency and Time Savings

  Streamline compliance processes and reduce manual efforts. Our LMS automates compliance tasks, saving time and resources while reducing the risk of errors.

• Global Accessibility and Scalability

  Enable learning from anywhere, anytime. With a cloud-based infrastructure, our platform ensures worldwide accessibility and scalability, accommodating the needs of your growing organization.

• Enhanced Training Effectiveness

  Elevate training effectiveness through interactive multimedia content, assessments, and real-time feedback, ensuring better knowledge retention and application.

• Regulatory-Grade Security Measures

  Rest assured of top-notch security measures. Our LMS employs encryption, intrusion detection, and regular security updates, automatic back-ups to keep your data protected.

• Tailored Learning Paths for Diverse Audiences

  Create personalized learning paths for different user groups, ensuring each learner receives relevant and targeted training.

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.

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:

• Training companies and individuals on how to use computer systems and software, as well as to troubleshoot them when they are not working effectively.
• Maintain secure, safe data that is protected from all threats and ensure that data does not get lost or corrupted.
• Ensure that signatures for review and approval are valid and legitimate and cannot be the subject of dispute.
• Tracing changes to data during its lifecycle to monitor security and potential risks along the way.
• Detecting and/or preventing falsified records or records breaches.

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:

• Handwriting capture
• Scanning
• Digital signatures (with PIN codes or keys)
• Biometrics, such as fingerprints or facial recognition

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.

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:

• Electronic record storage and security
• Electronic signature validation and authentication

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:

• A compliance checklist
• A certificate of compliance
• Documentation of inspections and audits (passed)

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:

• Performance Qualification: Is the software performing as it should? Is it processing and storing records correctly and ensuring security compliance across the board?
• Installation Qualification: Has the software been correctly and securely installed, following all necessary protocols and security procedures?
• Operational Qualification: Is the software capable of meeting all of the regulatory requirements of CFR Part 11 and other necessary compliance requirements?

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.

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:

• A detailed audit trail. Regulators that are performing inspections are going to need a chronological record of the goings on within the company. It will be important to use a software tool that keeps records of how, when, and how often it is used. That way, when then auditors show up, you’ve got all the records creating themselves automatically.
• Security controls for user access. You aren’t going to want every employee in every part of your software platforms. Therefore, you’ll want to choose a platform that includes security features like unauthorized access detection and more. These controls make it easier for you to manage remote accounts, including data and signature integrity.
• Electronic signatures. Electronic signatures are unique to each user, just like ink signatures. They are legally binding and with a system that is Part 11 compliant, users will be able to sign things electronically and have them considered to be legally binding when done according to the letter of the code.

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:

• Logical and physical security
• Backups
• Disaster recovery
• Installation qualification
• Validation testing
• Vendor auditing

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.