Navigating the Complexities of 21 CFR Part 11 Audit Trail Requirements: A Life Sciences Perspective

In the life sciences industry, compliance with regulatory standards is paramount. One such critical regulation is the 21 CFR Part 11, issued by the U.S. Food and Drug Administration (FDA), which deals with electronic records and electronic signatures. A key aspect of this regulation is the management of audit trails, which are essential for ensuring data integrity, reliability, and compliance. This article delves into the major audit trail requirements of 21 CFR Part 11, highlighting their implications and importance in the life sciences sector.

Navigating the Complexities of 21 CFR Part 11 Audit Trail Requirements

1. Ensuring Audit Trail Security

Audit trail security is the cornerstone of 21 CFR Part 11 compliance. The regulation mandates that access to systems that manage electronic records be restricted to authorized individuals. This control is crucial to prevent unauthorized alterations and ensure the audit trail remains a trustworthy record of actions. According to 21 CFR 11.10(e), the audit trails must be secure and only accessible to authorized personnel, thereby maintaining the integrity of the records.

2. Computer-generated, Time-Stamped Audit Trails

The regulation stipulates that audit trails must be automatically generated by the system, negating the possibility of manual errors. Additionally, it is required that each entry in the audit trail be time-stamped, documenting the exact moment of the action, such as the creation, modification, or approval of records.

3. User Identity Verification and Action Tracking

Verifying the identity of the individual performing actions within the system is another critical requirement. The audit trail must accurately capture who performed each action, bringing accountability and traceability to the system operations. 21 CFR 11.10(g) underscores the need for authority checks to ensure that only authorized users can access the system.

4. Non-obfuscation of Previously Recorded Information

A vital aspect of audit trails under 21 CFR Part 11 is the preservation of previously recorded information. The regulation mandates that any record changes should not obscure earlier entries, thus maintaining a clear and complete history of all actions performed on the electronic records.

5. Retention and Accessibility of Audit Trail Documentation

The audit trail must be retained for a period of at least as long as required for the related electronic records and be readily available for agency review and copying. This requirement ensures that the audit trail can be scrutinized during FDA inspections or audits, maintaining regulatory compliance. Make sure your 21 CFR Part 11 validated LMS provides robust audit trail documentation.

Conclusion: The Importance of Compliance and the Benefits

Complying with the audit trail requirements of 21 CFR Part 11 is not just a regulatory necessity but also a strategic business decision. A well-managed audit trail system enhances data integrity, facilitates traceability and accountability, and prepares companies for regulatory inspections. Moreover, it plays a pivotal role in detecting and preventing data tampering, fraud, and unauthorized access, thereby safeguarding the interests of both the company and the end-users of their products.

In summary, the audit trail requirements of 21 CFR Part 11 are integral to the life sciences industry’s commitment to maintaining high standards of data integrity and regulatory compliance. As technology continues to evolve and become further embedded in the life sciences sector, adhering to these requirements becomes increasingly critical for companies looking to sustain and grow their market presence.

Updated: January 22, 202421 CFR Part 11, Blog, ,

All You Need to Know to Thoroughly Proofread Your e-Learning Courses

You’ve selected the ideal learning management system (which is obviously eLeaP), you created amazing employee training courses, and now you’re ready to launch them for your employees.

Right?

Not so fast.

Before launching anything, you need to make sure you’ve done something critical but frequently overlooked: proofing.Screen Shot 2015-09-30 at 11.39.37 AM

Proofreading is one of those dreaded tasks in the corporate world, but it’s not avoidable.

If you don’t review your content before releasing it to employees, you can come off as unprofessional, and some of the avoidable mistakes can undermine training. Proofreading becomes even more important if you plan to sell your courses. You’re asking people to pay for content, so it needs to be as close to perfect as you can realistically make it.

What to Understand Before Editing Your e-Learning

Before you get started with the process of editing your courses, consider these general tips:

  • As you’re editing any of your work, even if it’s outside of e-Learning, make a list of the mistakes you most commonly see yourself making. By understanding these errors and noting them, you’ll be better prepared to find possible errors in subsequent work. For example, if your primary problem tends to be with subject-verb agreement, by knowing that ahead of time, you’ll be better prepared to fix these mistakes.
  • Don’t proofread your e-Learning right after you’ve finished creating a course. You’re probably going to be a bit bleary-eyed and fatigued if you’ve just finished creating a training course for your employees. Wait at least a few hours, and, ideally, a day or two before you begin the proofreading process. If you’re on a deadline to get a new course released to employees, include the time you think proofreading will take in your overall timeline. Don’t let yourself get in a time crunch and then be rushed or scrambling when it’s time to edit.
  • While grammar, spelling, and other technical issues are typically what we think of when we think of proofing, it’s just as important to use the editing process as a time to spot formatting errors, clunky navigation and other general style issues.
  • If your employees are going to be accessing the learning management system on a variety of devices or you have a Bring Your Own Device policy, then you should proof content on several types of devices as well. You want to see your employee training in the way your employees will see it. If you’re proofing on a laptop, and they’re primarily going to be using smartphones or tablets, this is going to be problematic.
  • Read e-Learning aloud. This is one of the best and most effective ways to thoroughly proof your work and also have a sense of how employees are going to perceive it. When you read it aloud you’re much more likely to catch not only grammatical errors but also errors in flow, sentence structure and wordiness.
  • Outsource the proofing. You should be the first person to proof training content, but then after that initial round it’s important to have someone with an outside perspective take a look. Ultimately you want your e-Learning to be free not only of grammatical, spelling and layout errors, but you also want it to make logical sense to trainees. You may have a concept of what you’re trying to convey in your mind, but does it come across this way to readers? By having a third party review your work, you’ll have a better idea not only of possible technical issues but also what ideas and concepts are coming across.
  • While proofreading is not most people’s idea of a good time, you can streamline the process a bit if you create a comprehensive checklist. Include all of the areas that need to be checked each and every time you create a course and then use that as your guide.
  • When in doubt, cut content. E-Learning has to be concise and to the point, otherwise you’re going to quickly lose your audience. One of your key goals during the proofing process should be to ensure everything is as to-the-point as possible. Make it your plan to cut at least 10 percent of what’s included in your initial design. Leave everything on an absolutely need-to-know basis.
  • Ask someone to not only proof the course but also take the course just as an employee would. If they’re approaching it from the perspective of the learner, you can get valuable feedback on how information flows, how well the navigation works, and how well your ideas are coming across.

Common Problem Areas in e-Learning

Of course, no one is going to be exactly the same when it comes to creating e-Learning content, but here are some common things to watch out for:

  • As we just mentioned, wordiness is a problem. Look through courses and keep an eye for complex sentences. Ask yourself if the content would be more concise and efficient if these sentences were broken up or shortened. Very long sentences don’t work well in a learning environment.
  • Think about homophones—like their and they’re. These are places where people tend to make a lot of errors, but even one of these issues can diminish the view of your e-Learning. If necessary, keep a list of homophones nearby when you’re proofing your work.
  • Proof your e-Learning courses from end to beginning, as well as vice versa. We always tend to start the proofing process at the beginning of a piece of work, which is fine, but you should also do it the other way around. This allows the final part of the course to be viewed with a fresh perspective, whereas every other time you’ve proofed it you may have lost steam by the time you got to the end.
  • Look for comma errors. Commas are often used sloppily and incorrectly in most types of writing, but they can have a serious impact on how content is read and understood. Pay careful attention to commas.
  • Another common area of confusion or mistakes in e-learning content is subject-verb agreement. If you have problems with subject-verb agreement, your learners are likely to be focused on that rather than what they’re meant to be learning.

Let us know your tips for the perfect proofreading process and the mistakes you most commonly see in your own work when you’re creating courses.

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Updated: August 1, 2023Blog, e-Learning

Exploring Multiple Choice Questions and Best Practices for Using Them

Just the thought of multiple choice questions can transport most of us back to our middle and high school days. Most school exams, including the dreaded standardized tests, featured a slew of multiple choice questions.

Screen Shot 2015-09-25 at 10.39.08 AMMany of us felt the overwhelming temptation to simply fill out these bubbles at random, but the desire to get into the college of our dreams was probably enough to divert that whim.

So what happens when you’re asked to participate in multiple choice assessments as an adult?

Assessments are imperative when it comes to training employees, and it’s easier to deliver multiple choice questions than many other question styles.

You can easily incorporate a multiple choice assessment into your employee e-Learning, and then have automated tracking and reporting that lets you know how employees are doing. Unfortunately, not all multiple choice questions are created equal, and not all are capable of providing the necessary level of training assessment.

Pitfalls of Multiple Choice Questions

Before you can begin creating multiple choice questions to assess the knowledge and understanding of your employees, it’s first important to understand why these types of questions have earned a bad reputation in the training and education worlds.

Terry Heick, an educator, wrote a piece that was published in the Washington Post citing reasons he feels multiple-choice assessments can be problematic.

Heick said the following:

“The multiple-choice problem is becoming a bit of an issue.

While it has been derided by educators for decades as incapable of truly measuring understanding, and while performance on such exams can be noticeably improved simply by learning a few tricks, the multiple choice question may have a larger, less obvious flaw that disrupts the tone of learning itself. This is a tone that is becoming increasingly important in the 21st century as access to information increases, as the updating of information happens more naturally, and as blended and mobile learning environments become more common.”

He went on to lay out three reasons multiple choice question assessments have become increasingly problematic. He cites tone, saying “learning depends on a rather eccentric mix of procedural and declarative knowledge- on the process as much as the end product.”

He then moves on to the issue of uncertainty, saying there’s nothing wrong with being uncertain. He says the more someone learns, the more uncertain they become. He lays out the issue that learning isn’t a neat, clean process, but instead is messy and full of uncertainty.

Finally, Heick says that multiple choice questions automatically give the learner the illusion that there is a clear-cut definition of right and wrong while information is inherently fluid.

Think about what Heick says in terms of training employees in any area from sales to healthcare. When handling situations that depend almost entirely on another person and there is no one set of things that are going to constantly occur because of the differences in individuals, do multiple choice questions work?

The answer is, it depends.

Creating Multiple Choice Questions to Promote Critical Thinking

Collage of human head, molecules and various abstract elements on the subject of modern science, chemistry, physics, human and artificial minds

Despite the criticisms of multiple choice questions, what’s crucial isn’t that assessments follow one particular style and avoid another. What’s important is that questions promote a sense of critical thinking, which is a vital part of employee training.

Some of the advantages of multiple choice questions include the fact that it’s simply easier to look at and measure the results. If you’re asking employees to complete written format assessments, you’re going to be at least somewhat responsible for reviewing and scoring the answers, which is time-consuming and can require a pretty significant amount of resources.

There’s also less possibility of bias, and there’s no subjectivity when it comes to measuring multiple choice results.

Finally, multiple choice-style assessments are simply less time consuming for employees. You want training and development to take up the least amount of employee time, while providing maximum results. Long-form assessment styles aren’t conducive to these goals.

The key to using multiple choice questions within your learning management system training is to work on creating items that are going to promote critical and higher level thinking, rather than hindering it.

Here are five tips that can help you design multiple choice questions that are going to give you an accurate picture of training effectiveness:

  • Include charts or data as part of the assessment. By asking employees to look at and analyze a set of data or a chart, it’s going to ensure they’re more immersed in training. This method is also going to promote a higher level of thinking when it comes to answering a question. There may only be one right answer in a set of multiple choice options, but employees are forced to really think when it comes to uncovering that answer. In addition to charts, other visual elements including videos and photos can make useful tools to delve deeper into the level of comprehension of employees.
  • Include real world scenarios. This is something that’s valuable throughout training. Make sure your questions incorporate real-life elements your employees face on the job.
  • Instead of traditional questions use a story as the question. Embed the actual question within a story. This requires employees to not only read and understand the story to understand the question, but it also requires that they analyze a particular situation. Rather than just choosing a right answer they’re looking at a unique situation and using critical thinking skills to determine the correct choice.
  • Create multi-level multiple choice questions, where respondents are not only asked to select the right answer but are also asked to go on to a second part of the question where they choose the reason.
  • Include several correct or plausible answers within a multiple choice questions, but ask employees to choose the one that’s the best. When there are multiple answers that could be correct, but only one that stands out above the others it’s going to promote a higher level of thinking than if there’s only one obviously correct answer and three that are blatantly incorrect.

Do you use multiple choice questions in your e-Learning assessments? How do you make sure they’re gauging the real comprehension of your employees?

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Updated: August 1, 2023Assessments, Blog, e-Learning, Training

Exploring Social Learning and How It Can Be Implemented with Social Media

As we’re nearing the end of 2015 one thing is pretty clear: social media isn’t a fad. It’s here to stay.

What was once a unique way to communicate with friends and family has now become a pivotal part of the business world as well. Social media is frequently used as a communication tool to reach clients and potential customers, but what role does it play in employee training and e-Learning? Continue reading →

Updated: September 25, 2015Blog, e-Learning, Social Learning

The Benefits of Experiential Learning and How to Create Realistic Training

Experiential learning may sound like something straight from an introductory philosophy class, but in reality it’s a concept that can be extremely valuable for training managers. Businesses are often asking themselves why their training and development isn’t resonating with employees. A common answer to that question lies in how realistic the learning feels to employees. Continue reading →

Updated: December 20, 2019Blog, e-Learning, Training

How to Incorporate Elements of Google’s Training and Development Into Your Business

Silicon Valley is undoubtedly enjoying time in the limelight right now. The area has become synonymous with technology, innovation, and pioneering companies. Millennials are flocking to these enterprises as they become the premier places to work in the world. From search engines to apps and even products like watches, it seems like tech companies in Northern California are on the cusp of everything new and exciting. That innovative spirit certainly extends to their employee management, and in particular how they train employees. Continue reading →

Updated: September 11, 2015Blog, e-Learning, Training

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