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21 CFR Part 11 (Electronic Records/Signatures) Compliance for Computer Systems Regulated by FDA

Faculty :

Industry :

Duration :

Course Description:

This webcast will help You understand in detail the application of FDAs 21 CFR Part 11 guidance on electronic records/electronic signatures (ER/ES) for computer systems subject to FDA regulations. This is critical in order to develop the appropriate validation strategy and achieve the thoroughness required to prove that a system does what it purports to do. It also ensures that a system is maintained in a validated state throughout its entire life cycle, from conception through retirement.

ER/ES capability can vary, and the approach should be based on the specific case and the risk of failing to meet the guidance associated with it.

Why should you Attend?

You should attend this webinar if you are responsible for planning, executing or managing the implementation of any system governed by FDA regulations that uses ER/ES capability, or if you are maintaining or supporting such a system.

Effective and compliant computer system validation is critical to any pharmaceutical or FDA-regulated organization. During the past 30 years, best practices that have been developed will ensure that validation activities are cost-effective while meeting all aspects of FDA compliance.

There is an enormous body of documentation and information available that can be overwhelming. This course will provide a condensed overview of the key practices that deliver the best results by directing the attendees to the most critical and cost-effective methods, techniques and tools available.

Areas Covered:

This 90 mins course will cover:
  • GxP systems regulated by FDA
  • Computer System Validation (CSV) methodology
  • System Development Life Cycle (SDLC) framework
  • 21 CFR Part 11 guidance for electronic records/signatures (ER/ES)
  • Cost-benefit and rationale for implementing ER/ES
  • Security and Access
  • User roles and profiles
  • Workflow and approvals
  • Document tracking
  • Risk and mitigation associated with ER/ES
  • Organizational change management for users
  • Potential pitfalls for ER/ES implementation
  • ER/ES best industry practices with examples
Learning Objectives :
  • Gain an understanding of FDAs 21 CFR Part 11 Electronic Records/Electronic Signatures (ER/ES) guidance document
  • Develop the ability to apply 21 CFR Part 11 when implementing, validating and maintaining computer systems in your organization
  • Understand the best practices for maintaining a computer system with ER/ES capability in a validated state
  • Understand some of the key ?pitfalls? to avoid when employing ER/ES capability and learn more.

Who will benefit?

  • Information Technology Analysts
  • Information Technology Developers and Testers
  • QC/QA Managers and Analysts
  • Clinical Data Managers and Scientists
  • Analytical Chemists
  • Laboratory Managers
  • Automation Analysts
  • Computer System Validation Specialists
  • GMP Training Specialists
  • Business Stakeholders/Subject Matter Experts
  • Business System/Application Testers

Registration Options


Avail 12 months unlimited access for a single user.


Material shipped within 15 days post webinar completion & get life time access for unlimited participants.



Speaker Details

Carolyn  Troiano

Carolyn Troiano

FDA/Medical Device Consultant

Carolyn Troiano  has more than 35 years of experience in computer system validation and compliance in the pharmaceutical, medical device, tobacco and other FDA-regulated industries.  

Refund Policy



Participants/Registrants for our live events, may cancel up to 72 hours prior to the start of the live session and ComplyArena will issue a letter of credit to be used towards any of ComplyArena's future events. The letter of credit will be valid for 12 months.

ComplyArena will process refund in cases where the event has been cancelled and is not rescheduled within 90 days from the original scheduled date of the webinar. In case if a live webinar is cancelled, participants/registrants may choose between recorded version of the course or a refund. Refunds will not be processed to participants who do not show up for the webinar. A webinar may be cancelled due to unavoidable circumstances, participants will be notified 24 hours before the scheduled start of the event. Contact us via email: admin@complyarena.com or call +1-888-222-5917 (Toll Free).