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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

Course Code Location Class Begins Class Ends Daily Schedule Course Delivery Class Agenda Registration
DIS VIRTUAL DELIVERY (Eastern Time) 05 Dec 2023 06 Dec 2023 1:00PM - 5:00PM Eastern US Time Virtual REGISTER


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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 Basis for Computer Systems and Applications

  • Describe regulatory requirements for QMS software systems
  • Describe the perspective of risk-based approach for manufacturers
  • Describe US FDA emphasis on computer system controls and data integrity

Regulatory Expectations and Part 11

  • Define electronic records and electronic signatures in 21 CFR Part 11
  • Identify software used for processes and records in the QMS and their requirements
Workshop! Walk Through How to Assess if Software Is in Scope/Out of Scope for Part 11
Workshop! Walk Through Assessing Gaps for Part 11, Using the Organization’s Procedures and Forms

Implementation and Applications

  • Explain current regulatory expectations regarding data and record integrity
  • Explain and review data integrity principles
  • Describe data integrity oversight and governance
  • Describe processes to have in place for data integrity
  • Identify audit trails within Part 11 software applications to determine compliance
  • Identify opportunities that lend themselves to compliance problems
  • Review the system controls and requirements currently in place (e.g., access control, management control, file structure, and data management across the entire data life cycles)
Workshop! Using Your Organization’s Application

Preparing for Regulatory Review

  • Preparing rationale for electronic records in regulatory submissions
  • Describing the management and risk-based control of Part 11 complaint systems
What You Will Learn

What You Will Learn

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

Describe 21 CFR Part 11 requirements for electronic records and signatures.

Describe US regulatory expectations and guidance for data integrity.

Examine how to implement risk-based 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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