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FDA 21 CFR Part 11 Training: Pharmaceutical Data Integrity, ALCOA+, and Electronic Records

In this course, you will obtain the knowledge and practical application experience needed to ensure your devices and regulated IT systems maintain or exceed the high level of quality expected by FDA. This course specifically focuses on appropriately maintaining electronic records, electronic signatures, and the data integrity of software systems used in the pharmaceutical industry.

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Brief Overview of This Course on Data Integrity for Pharmaceutical Manufacturers

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 (CEUs)


* SkillsLab classes delivered in-person (private or public) are full-day sessions delivered in 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 Training Classes on Part 11 Compliance for Pharma Manufacturers

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 Pharma Manufacturers

FDA is changing its approach to regulating software in quality systems. Simply following their guidance has not been enough for the pharma industry to guarantee the high quality of systems that FDA expects. Manufacturers will now be responsible for determining their own controls and justifying their effectiveness to regulators rather than following explicitly prescribed guidance.

Course Overview
SkillsLab Class

Regulatory Basis for Computer Systems and Applications

  • Regulatory requirements for quality management system (QMS) software systems and GxP
  • Risk-based approach for manufacturers
  • US FDA emphasis on computer system controls and data integrity

Data Integrity in Electronic Records

  • Regulatory focus on data integrity
  • 21 CFR Part 11 electronic documents and records
  • Assessing software used in the QMS
Exercise! Assessing the QMS or PQS for Gaps
Exercise! Assessing Systems for GxP Applicability
Exercise! Assessing Part 11 Gaps

Implementation and Applications

  • Data integrity culture
  • Evaluating and controlling data
  • Implementing controls
Exercise! Evaluating Raw Data
Exercise! Assessing Systems

Preparing for Regulatory Review

  • Electronic records in regulatory submissions
  • Part 11 enforcement
  • Management and risk-based control of Part 11-compliant systems
What You Will Learn

What You Will Learn

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

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

Describe US regulatory expectations and guidance for data integrity ALCOA+.

Examine how to implement risk-based and critical thinking to apply the best approach to a specific system.

Who Should Attend

Who Should Attend

Anyone in a pharma organization responsible for managing procedures, approvals, and data in electronic form. All RA/QA professionals and other cross-functional team members.

  • Procedures Managers
  • Approvals Managers
  • Data Managers
  • RA/QA Professionals
  • Cross-Functional Team Members

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