Student Login |

Tuesday, July 07, 2020
Home » Electronic Signatures & Records - 21 CFR Part 11

Electronic Signatures & Records - 21 CFR Part 11 (ESR01)

Certification Training
Rated 4.38/5
8 reviews
Method of Training: Online / Self-paced eLearning.
Credit Hours: 2 credits.
Duration: ~2 hour(s).
Self-paced Training: 24/7 access to course.
Enrollment Period: 3 months.
Catalog: Electronic Records.
Demonstration: Try one of our FREE courses.
Certificate: View sample certificate.

PRICE: USD $195.00

Demonstrate your dedication to job performance by earning a training certification from Biopharma Institute.

Biopharma Institute LogoTraining Program: Electronic Signatures & Records - 21 CFR Part 11
Training Provided By: Biopharma Institute

Schedule: Self-paced. Immediate access to training materials upon ordering.

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

The Food and Drug Administration established a set of rules for electronic signatures and electronic records back in 1997. The Electronic Signatures & Records- 21 CFR Part 11 Course is designed to explain why these regulations were developed, and the roles they play in accordance to other sections of 21 CFR. Students will have the chance to explore the general concepts of security in a Part 11 compliant system. Course completion requirements include passing an online, multiple-choice final assessment.

Benefits of Getting Certified at BioPharma Institute

For over two decades, BioPharma Institute has been providing comprehensive and flexible online training solutions for thousands of organizations across the pharmaceutical, healthcare, and biotechnology industries. Our eLearning solutions make it extremely convenient for professionals to upgrade their skills within a flexible schedule, and without having to allocate time to conduct or attend live training programs.

Each course is designed to engage students via an active learning process with tools such as live and recorded seminars, online books, high quality animations, and more. You can rest assured that we cater to both small-scale and large-scale training requests as well.

Have Questions?

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 passing score within a 90-day period of time (180 days for Professional Certification Programs). Certificate is accessible in PDF format immediately after satisfying requirements.


1. Course Information
2. Interface Tour
3. Course Overview

4. Objectives
5. The Need for Part 11
6. Electronic Records
7. Developer vs. User Requirements

8. Objectives
9. General Concepts
10. Passwords
11. Open and Closed Systems
12. Data Management

13. Objectives
14. General Concepts
15. Electronic Signatures

16. Objectives
17. Training
18. Supporting Procedural Infrastructure

19. Objectives
20. Validation
21. Security Issues
22. Compliance

23. Summary


Describe how the need for regulations on electronic records led to the creation of Part 11.
Identify the Part 11 regulations and their scope.
Explain how Part 11 relates to other sections of 21 CFR. Describe why Part 11 compliance makes both legal and business sense.
Explain the FDA trickle-down theory of regulation. Identify the main areas of security concern and the implications of threats in these areas.
Explain how passwords are used to protect data and the importance of NOT sharing passwords.

Full List of Programs in the Electronic Records Catalog:

Compliance in Electronic Signatures & Records Professional Certification Program: The Compliance in Electronic Signatures & Records Professional Certification Program covers two areas of training, including and introduction to compliance and compliance with specific respect to regulation 21 ... Learn more

Electronic Signatures & Records - 21 CFR Part 11: The Food and Drug Administration established a set of rules for electronic signatures and electronic records back in 1997. The Electronic Signatures & Records- 21 CFR Part 11 Course is designed to explain why t ... Learn more

Compliance with Regulation 21 CFR Part 11 on Electronic Records and Electronic Signatures: Part 11 of Title 21 of the US Code of Federal Regulations (21CFR11) sets out requirements that computer systems must meet to satisfy the Food and Drug Administration (FDA), and to assure that electronic records ... Learn more

Online Training: The Benefits of eLearning

  • Immediate access to training: Instructions, username, password, and receipt of payment are 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 for professional certification programs for 180 days
  • Flexible final assessments: Assessment testing include multiple-choice questions and can be taken repeatedly until a passing score is achieved
  • Direct access to certificates: Certificate of completion is instantly available once course requirements have been fulfilled
  • Verification of training: Certificates can be verified online, and digital badges are issued for all Professional Certification programs
  • Tuition reimbursement: Some employers may reimburse for training expenses; check on your company's requirements
  • Financial assistance: Payment plans are available to those who qualify. These are offered when paying electronic invoices, online. You must first request an invoice to be considered. Alternatively, purchasing individual courses one at a time is also an option
  • Purchase orders (POs) accepted: If a PO is required by your company, request an invoice to start the procurement process
  • Corporate LMS compatibility: All courses are SCORM compliant and can be delivered from most corporate Learning Management Systems
  • Secure and safe access: Website and LMS provide an encrypted connection with firewall protection and daily scans for optimal level of security and performance
  • Career advancement: Professional certifications help demonstrate your interest and dedication to job performance, and may be helpful for those seeking a new career or transitioning to different positions within their organization

Contact Us:

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

Information Request / Suggest a Course Form:

Enter the number from the image above
COMMENTS or Suggest a course:
(For pricing information, please provide us with as much detail as possible about your training project):