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Saturday, March 23, 2019
Home » 21 CFR Part 11: Compliance for Electronic Medical Records

21 CFR Part 11: Compliance for Electronic Medical Records (ESR07)

Certification Training
Duration: 1.3 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.

Contact the BioPharma Institute for more information.

BioPharma Institute LogoTraining Program: 21 CFR Part 11: Compliance for Electronic Medical Records
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: Compliance for Electronic Medical Records is one of the training components of the Electronic Signatures & Records Professional Certification Program. The use and storage of medical records has drawn a huge debate from many stakeholders in the recent past, with issues such how these records should be assessed taking center-stage. This course provides an overview of the FDA guidelines that generally regulate the storage and use of medical records. Once completed, the students are assessed using a multiple-choice examination and a passing grade of at least 80% is required. The test can be taken with an unlimited number of tries.

Benefits of Getting Certified at BioPharma Institute

Stellar online pharma training courses recognized by major players in various industries are hard to come by, and BioPharma Institute is one of the top providers of such courses. For over two decades, we have been catering to the training needs of both large corporations and small businesses when it comes to keeping them updated about FDA regulations and compliance standards in the biotech, pharma, and healthcare industries.

BioPharma Institute's training courses are suitable for industry veterans who are interested in upgrading their skills, as well as individuals who are being introduced into their new job scopes for the first time. We make learning easy by use of a variety of media, including high-definition animations, books, voiceovers, and more. When you choose our institute, you are guaranteed an excellent education delivered through a convenient and effective method to training.

Have Questions?

If you are interested in any aspect of this course, feel free to contact 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: Compliance for Electronic Medical Records course is found in the following professional certification program(s):


Review of current status of 21 CFR Part 11.
What is the relationship between validation and part 11 compliance to electronic medical records?
What do I have to do today to be in compliance?
What changes can I expect to see in Part 11?
When will I need to be in compliance?
What is the future part 11 likely to look like?
How can I best integrate part 11 compliance into my quality system?
How can I ensure what I do today will stand inspection tomorrow?


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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