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How to go Paperless in an FDA-Regulated Environment using Electronic Workflow Signature Approvals and Electronic Records

This course equips regulated-industry professionals with the decision framework and implementation knowledge needed to adopt electronic records and signature workflows in full alignment with 21 CFR Part 11, reducing compliance risk while improving operational efficiency. This course is designed for professionals in FDA-regulated industries involved in systems compliance, records management, or validation oversight.

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US $190 per learner

30-Days Unlimited Streaming Access

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REGISTER FOR THE COURSE

To Get 30-Day Access to ONLY this Course 

US $190 per learner
  • This course is Included in Subscription Pack
Subscription include access to entire Learning Library
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  • Instructor : Carolyn Troiano
  • Study time : 75 Minutes
  • Skill Level: Intermediate
  • Course ID: TF2146
  • Assessment & Certification Included
  • Ask the Expert

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About the Course

Operating in a paperless environment under FDA oversight requires more than adopting software — it demands a structured approach to security, access controls, signature authentication, and audit readiness. 21 CFR Part 11 defines specific requirements for electronic records and electronic signatures, and gaps in implementation carry direct regulatory consequences. Organizations that proceed without a validated, compliant framework risk audit findings, system failures, and costly remediation.

This course addresses the full scope of ER/ES implementation: from evaluating readiness and conducting cost-benefit analysis, to managing organizational change, defining roles, and integrating electronic signature capability into existing applications. It also prepares professionals for FDA audits targeting these systems, covering what inspectors look for and how compliant workflows should be documented and defended.

  • Build a Compliant ER/ES Implementation Strategy:

    Professionals will leave with a structured approach to evaluating, implementing, and maintaining electronic records and signature systems that satisfy FDA's 21 CFR Part 11 requirements. This includes understanding the System Development Life Cycle for validation, identifying key roles, and documenting rationalization — all essential before moving to a paperless workflow.

  • Assess Risk and Prepare for Regulatory Scrutiny:

    FDA audits increasingly scrutinize electronic record and signature systems. This course addresses known implementation risks, mitigation strategies, and what constitutes audit-ready documentation. Understanding both the threats and the operational opportunities of ER/ES capability positions professionals to make informed decisions that hold up under regulatory review.

Key Areas Covered

  • 21 CFR Part 11 requirements for electronic records and electronic signatures, including security controls and signature authentication
  • Pros, cons, and cost-benefit analysis of implementing ER/ES capability in a regulated environment
  • System Development Life Cycle (SDLC) approach to validation of ER/ES systems
  • Risk assessment for ER/ES implementation and methods for mitigating identified threats
  • Organizational change management and key roles required to implement and sustain ER/ES capability
  • Integration of ER/ES into existing applications and documentation of rationalization
  • Preparing applications and documentation for FDA audit scrutiny involving electronic records and signatures
  • Real-world examples of ER/ES implementation outcomes, including both successful and unsuccessful cases

Who Must Attend

  • QA/QC Departments
  • Information Technology Departments
  • Validation Departments
  • Clinical Data Managers and Scientists
  • Analytical Chemists
  • Laboratory Managers
  • CSV Specialists
  • GMP Training Specialists

Quality training, expert insights, and answers that matter. Know your Expert

Carolyn Troiano

Carolyn Troiano brings more than 30 years of direct experience in computer system validation across pharmaceutical, medical device, animal health, tobacco, and other FDA-regulated industries. She was involved in the development of 21 CFR Part 11 through collaboration with FDA and industry representatives, and has built validation programs and ER/ES strategies for major pharmaceutical companies in the US and Europe. She currently consults on computer system validation and large-scale IT implementation.

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