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Home » 21 CFR Part 11: Ins and Outs of Audit Trails

21 CFR Part 11: Ins and Outs of Audit Trails (ESR04)

Certification Training
Duration: 1.4 hours, Online (the average time to complete the training program, including final assessments).
Credits Hours: 1
Self-paced Training: 24/7 access to course.
Enrollment Period: 3 months.
Demonstration: Try one of our FREE courses.
Certificate: View sample certificate.

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BioPharma Institute LogoTraining Program: 21 CFR Part 11: Ins and Outs of Audit Trails
Training Provided By: BioPharma Institute

Availability: Immediately available upon ordering.

Description: Online training with immediate access upon enrollment. BioPharma Institute Reviews

The 21 CFR Part 11: Ins and Outs of Audit Trails Course is one of the courses found in the Electronic Signatures & Records Professional Certification Program. It is designed to lay out the various types of audit trails and effective strategies of implementing compliant audit trails whilst staying compliant with 21 CFR Part 11 regulations. Students will need to pass an online, multiple-choice final assessment after viewing the entire program to launch a certificate of completion via PDF.

Benefits of Getting Certified at BioPharma Institute

BioPharma Institute is a leading organization you can trust for online training courses that are recognized across a wide range of biotech, pharmaceutical, and healthcare industries. Since our inception, we have been training employees from both large corporations and small businesses. We also cater to individuals who are looking to refresh or upgrade their skills and excel their careers.

Our eLearning system comprises of easy to use learning tools, such as high quality animations, progress checks, online books, and more. These tools help our students understand the different learning concepts in a short time. What's more, our online training solutions eliminate the need to conduct physical lessons which could be time-consuming and expensive.

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Should you have any particular question about this course, you can call us at (888) 424-6576 or send us an email at for more information.

Certification Requirements: Students must view the entire program and successfully pass an online, multiple-choice final assessment with >80% passing grade within a 90 day period of time (180 days for Professional Certification Programs). Certificate is accessible in PDF format immediately after satisfying requirements.

The 21 CFR Part 11: Ins and Outs of Audit Trails course is found in the following professional certification program(s):


-Subsection of Part 11 and Interpretation of the subsection.
-Types of audit trails and Strategies of implementing compliant audit trails.
-Audit Trail Pros and Cons.
-Audit Trail As an Auditing Tool.
-Audit Trail Shoulds and Shouldn'ts.
-What if's?
-What is next about 21 CFR Part 11.
-Commonly asked questions about Audit Trail.


-The objective for this training is to provide the learner with a deeper knowledge within this subject matter.

Online Training Program Benefits:

  • Immediate access to training: Instructions, username, password and receipt of payment emailed instantly upon online enrollment
  • Optimized for learning: Courses include voice-overs, easy navigation, progress checks, and high-quality animations to increase retention of subject matter
  • Self-paced courses: 24/7 access to individual courses for 90 days; and 180 days for professional certification programs
  • Flexible final assessments: Tests include multiple-choice questions and can be taken repeatedly until a passing score is achieved
  • Direct access to certificates: Documentation instantly available once course requirements have been fulfilled
  • Verification of training: Certificates can be verified online, and electronic badges are issued for all Professional Certification programs
  • Corporate reimbursements: Employers may pay for or reimburse employees for training. Purchase orders (POs) for both individual and group training are accepted
  • Corporate LMS solutions: All courses are SCORM compliant and can be delivered from most corporate Learning Management Systems
  • Secure and safe access: Website and LMS offer an encrypted connection with firewall protection and daily scans for optimal level of security and performance
  • Career advancement: Professional certifications may be helpful for those seeking new careers or transitioning to different positions within their organization

For more information on the BioPharma Institute's training programs, or to suggest a course, please complete the form located below. Alternatively, you may call toll free in the US: (888) 4-BIO-LRN, international callers can dial (201) 301-8370, or email

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