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FDA Part 11 Compliance and Medical Device Data Integrity Training

FDA Part 11 compliance involves so much more than e-signing documents and storing them securely. In this class, we will guide you through all facets of compliance with FDA 21 CFR Part 11 requirements governing electronic signatures and records. You’ll see excerpts referencing data integrity from several real FDA warning letters, and review six common misconceptions that companies have about Part 11 compliance. At the conclusion of this class you will understand why FDA places so much emphasis on computer system controls, how Part 11 ensures data integrity, the “predicate rules” related to electronic records, and your overall Part 11 obligations.

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Brief Overview of This Course on Medical Device Data Integrity

SkillsLab Class ?

Class Content


Class Duration

2 Half-Days*

Teaching Format

Live, Instructor-Led

Delivery Options

Virtual or In Person**

Certification of Completion


Continuing Education Units (CEU)


* SkillsLab classes delivered in-person (private or public) are full-day sessions delivered over 1 day. 

** Interested in private training for your team, virtually or in-person at your facility? See more details or ask us about it!

Upcoming Classes

Upcoming FDA 21 CFR Part 11 Training Classes

SkillsLab $1495

There are no public training classes scheduled right now but this class can be delivered privately to 6 or more people at any time. Ask us for details!


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Register 3 people, 4th attends free!


*This offer cannot be combined with any other promotional offer(s).

Course Overview

Here's What We Cover in This Class on Part 11 Compliance for Medical Device Manufacturers 

Medical device RA/QA professionals focus so much on document creation and data collection that they sometimes overlook the importance of proper record maintenance and data integrity. In this class you will get practical knowledge needed to ensure compliance to US regulations regarding electronic records, electronic signatures, and data integrity in software systems used in medical device quality management systems. Moreover, you’ll learn about the linkages with cybersecurity and validation in document and data management systems.

Course Overview
SkillsLab Class

Regulatory Focus on Data Integrity

  • Why FDA focuses on integrity
  • Characteristics of data integrity (ALCOA plus)
  • FDA emphasis on computer system controls and data integrity
  • Activity! Evaluate Examples
  • Software validation: regulations, guidance, and standards
  • Using a risk-based approach for software validation
  • How regulators assess regulated IT systems
  • Exercise! Assess System for GxP Applicability

Part 11 Requirements for Data Integrity

  • Which records are covered by Part 11?
  • Role of predicate rules
  • Part 11 requirements for records, electronic signatures, information security
  • FDA's approach to enforcing Part 11 requirements
  • Exercise! Assess Part 11 Gaps

Implementation and Applications

  • Threats to data integrity
  • Data governance
  • Data integrity responsibilities in the organization
  • Exercise! Identify Risks to Data
  • Protecting data integrity
  • Auditing data integrity
  • Activity! Evaluate Examples

Data Integrity in Regulatory Submissions

  • Data integrity for electronic records and data used in regulatory submissions
  • Using a risk-based approach to Part 11 compliance
  • Activity! Identify Next Steps for Your Organization
What You Will Learn

What You Will Learn

At the conclusion of this training class, you will be able to

Describe US regulatory expectations and guidance for data integrity.

Describe US regulatory expectations and guidance for data integrity.

Implement controls to protect data integrity, and use a risk-based approach and critical thinking to apply the best approach to a specific system.

Who Should Attend

Who Should Attend

Recommended for quality assurance and regulatory affairs professionals, as well as other cross-functional team members in a medical device environment. All attendees must have some familiarity with FDA 21 CFR Part 820.

  • Document Control Specialists
  • Quality & Regulatory Professionals
  • Design Control Team Members
  • Cross-Functional Team Members
  • Postmarket Specialists

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