Audit Trails & Data Integrity: Ensuring FDA 21 CFR Part 11 Compliance
Prevent Costly Compliance Risks with Strong Audit Trail Controls!
Instructor :
Carolyn Troiano
Webinar ID:
13562
Date: APR 24, 2025 (THU)
Start Time: 10 AM PT - 11:30 AM PT
Duration: 90 Mins.
What you will learn
-
- Identify GxP Systems and Their Role in Compliance
- Implement Audit Trails to Ensure Data Integrity & Security
- Apply Computer System Validation (CSV) Best Practices Effectively
- Understand FDA 21 CFR Part 11 Compliance Requirements
- Develop Risk-Based Validation Strategies for GxP Systems
- Prepare for FDA Audits with Strong Compliance Measures
- Leverage Procedural Controls When Audit Trails Are ….
-
- Identify GxP Systems and Their Role in Compliance
- Implement Audit Trails to Ensure Data Integrity & Security
- Apply Computer System Validation (CSV) Best Practices Effectively
- Understand FDA 21 CFR Part 11 Compliance Requirements
- Develop Risk-Based Validation Strategies for GxP Systems
- Prepare for FDA Audits with Strong Compliance Measures
- Leverage Procedural Controls When Audit Trails Are Not Available
- Conduct Vendor Audits to Ensure Regulatory Compliance
Course Description
The integrity of electronic records is a critical aspect of FDA 21 CFR Part 11 compliance.
In recent years, regulatory citations related to audit trails and data integrity have significantly increased, underscoring the need for robust controls to ensure that no original record is altered, obscured, or deleted before the end of its retention period.
In this comprehensive training, you will gain a deep understanding of audit trails, their role in data integrity compliance, and the common pitfalls companies face when implementing and managing them.
You will learn how to:
-
- Understand the essential role of audit trails in maintaining regulatory compliance.
- Implement audit trails correctly to capture every modification, including old and new values, timestamps, user details, and reasons for changes.
- Identify and mitigate compliance risks associated with inactive, modified, or missing audit trails.
- Address challenges in legacy systems that lack built-in audit trail functionality and explore alternative procedural controls.
- Leverage audit trails for analysis and trending to uncover potential training deficiencies and process inefficiencies.
- Apply industry best practices for evaluating computer systems, ensuring data integrity, product quality, and patient safety.
- Navigate the System Development Life Cycle (SDLC) for risk-based validation of electronic records and signatures.
- Prepare for FDA inspections by developing essential policies, procedures, and documentation.
- Audit and assess third-party vendors for compliance with computer system hardware, software, and services.
This course provides a practical, compliance-driven approach to implementing and managing audit trails effectively, ensuring your organization remains fully aligned with FDA regulations and industry best practices.
Enroll Now!
The integrity of electronic records is a critical aspect of FDA 21 CFR Part 11 compliance.
In recent years, regulatory citations related to audit trails and data integrity have significantly increased, underscoring the need for robust controls to ensure that no original record is altered, obscured, or deleted before the end of its retention period.
In this comprehensive training, you will gain a deep understanding of audit trails, their role in data integrity compliance, and the common pitfalls companies face when implementing and managing them.
You will learn how to:
-
- Understand the essential role of audit trails in maintaining regulatory compliance.
- Implement audit trails correctly to capture every modification, including old and new values, timestamps, user details, and reasons for changes.
- Identify and mitigate compliance risks associated with inactive, modified, or missing audit trails.
- Address challenges in legacy systems that lack built-in audit trail functionality and explore alternative procedural controls.
- Leverage audit trails for analysis and trending to uncover potential training deficiencies and process inefficiencies.
- Apply industry best practices for evaluating computer systems, ensuring data integrity, product quality, and patient safety.
- Navigate the System Development Life Cycle (SDLC) for risk-based validation of electronic records and signatures.
- Prepare for FDA inspections by developing essential policies, procedures, and documentation.
- Audit and assess third-party vendors for compliance with computer system hardware, software, and services.
This course provides a practical, compliance-driven approach to implementing and managing audit trails effectively, ensuring your organization remains fully aligned with FDA regulations and industry best practices.
Enroll Now!
Why you should attend
Navigating FDA 21 CFR Part 11 compliance can be complex, especially when it comes to audit trails and data integrity. Without proper controls, companies risk regulatory citations, data inconsistencies, and compliance failures.
This training is designed to provide practical solutions to these challenges, equipping you with the knowledge to ensure regulatory readiness and protect electronic records.
By attending, you will:
-
- Gain clarity on FDA expectations for electronic records, audit trails, and data integrity compliance.
- Understand how to validate and defend audit trails throughout the data retention period.
- Learn effective workarounds for legacy systems that lack built-in audit trail functionality.
- Discover vendor strategies to ensure full traceability and compliance.
- Streamline validation processes to enhance efficiency and reduce compliance risks.
- Prepare for FDA inspections with internal audits that identify and remediate potential data integrity gaps.
This course offers actionable insights and industry best practices to help you stay ahead of compliance challenges and ensure your organization meets FDA regulatory requirements with confidence.
Join Now!
Navigating FDA 21 CFR Part 11 compliance can be complex, especially when it comes to audit trails and data integrity. Without proper controls, companies risk regulatory citations, data inconsistencies, and compliance failures.
This training is designed to provide practical solutions to these challenges, equipping you with the knowledge to ensure regulatory readiness and protect electronic records.
By attending, you will:
-
- Gain clarity on FDA expectations for electronic records, audit trails, and data integrity compliance.
- Understand how to validate and defend audit trails throughout the data retention period.
- Learn effective workarounds for legacy systems that lack built-in audit trail functionality.
- Discover vendor strategies to ensure full traceability and compliance.
- Streamline validation processes to enhance efficiency and reduce compliance risks.
- Prepare for FDA inspections with internal audits that identify and remediate potential data integrity gaps.
This course offers actionable insights and industry best practices to help you stay ahead of compliance challenges and ensure your organization meets FDA regulatory requirements with confidence.
Join Now!
Areas Covered
1. Introduction to GxP Systems and Compliance
-
- Identifying GxP Systems and their significance in FDA-regulated environments
- Overview of regulatory expectations for computer systems handling electronic records
2. Computer System Validation (CSV) & System Development Life Cycle (SDLC)
-
- Understanding the CSV approach based on FDA requirements
- Implementing the SDLC methodology for risk-based validation
- Best practices for documenting validation efforts, including:
-
- Requirements, design, and development
- Testing and operational maintenance
-
3. Audit Trails & Data Integrity in Compliance with FDA 21 CFR Part 11
-
- Understanding the role of audit trails in data integrity and compliance
- Risks of not implementing audit trails and how to mitigate them
- Leveraging procedural controls when technical audit trails are not feasible
4. Policies, Procedures & Documentation for Compliance
-
- Essential policies and procedures to support validation and ongoing system maintenance
- Ensuring proper GxP documentation aligned with FDA expectations
- Developing strategies to maintain a validated state throughout a system’s lifecycle
5. Regulatory Considerations & Risk-Based Validation
-
- Key components of FDA 21 CFR Part 11 compliance for electronic records and signatures
- Regulatory influences shaping FDA’s expectations on validation and data integrity
- Conducting risk assessments to determine:
-
- System complexity, business criticality, and GAMP®5 category
- Potential compliance risks and strategies to mitigate failures
-
6. Preparing for Inspections & Vendor Oversight
-
- Steps to effectively prepare for an FDA inspection or audit of GxP systems
- Best practices for conducting vendor audits to ensure compliance with FDA standards
- Industry best practices for validation and compliance optimization based on risk assessment
7. Q&A Session
-
- Open discussion to address participant questions and real-world challenges
BONUS:
-
- PDF copy of the presentation handout for your future reference.
- Soft copy of the certificate of completion on request.
- Q&A Session with the Presenter: Get your pressing questions answered verbally, via chat or email
1. Introduction to GxP Systems and Compliance
-
- Identifying GxP Systems and their significance in FDA-regulated environments
- Overview of regulatory expectations for computer systems handling electronic records
2. Computer System Validation (CSV) & System Development Life Cycle (SDLC)
-
- Understanding the CSV approach based on FDA requirements
- Implementing the SDLC methodology for risk-based validation
- Best practices for documenting validation efforts, including:
-
- Requirements, design, and development
- Testing and operational maintenance
-
3. Audit Trails & Data Integrity in Compliance with FDA 21 CFR Part 11
-
- Understanding the role of audit trails in data integrity and compliance
- Risks of not implementing audit trails and how to mitigate them
- Leveraging procedural controls when technical audit trails are not feasible
4. Policies, Procedures & Documentation for Compliance
-
- Essential policies and procedures to support validation and ongoing system maintenance
- Ensuring proper GxP documentation aligned with FDA expectations
- Developing strategies to maintain a validated state throughout a system’s lifecycle
5. Regulatory Considerations & Risk-Based Validation
-
- Key components of FDA 21 CFR Part 11 compliance for electronic records and signatures
- Regulatory influences shaping FDA’s expectations on validation and data integrity
- Conducting risk assessments to determine:
-
- System complexity, business criticality, and GAMP®5 category
- Potential compliance risks and strategies to mitigate failures
-
6. Preparing for Inspections & Vendor Oversight
-
- Steps to effectively prepare for an FDA inspection or audit of GxP systems
- Best practices for conducting vendor audits to ensure compliance with FDA standards
- Industry best practices for validation and compliance optimization based on risk assessment
7. Q&A Session
-
- Open discussion to address participant questions and real-world challenges
BONUS:
-
- PDF copy of the presentation handout for your future reference.
- Soft copy of the certificate of completion on request.
- Q&A Session with the Presenter: Get your pressing questions answered verbally, via chat or email
Who is this course for
Everybody Benefits from Watching This. Even Better When Done as a Group!
-
- Regulatory Affairs Professionals Ensuring Compliance Standards
- Quality Assurance Specialists Managing Data Integrity Controls
- Compliance Officers Overseeing FDA 21 CFR Part 11 Requirements
- IT & System Administrators Handling GxP Computer Systems
- Clinical & Laboratory Managers Maintaining Electronic Records Compliance
- Validation & CSV Specialists Conducting Risk-Based System Validation
- Pharmaceutical & Biotech Professionals Working with Regulated Data
- Medical Device Manufacturers Implementing Audit Trail Best Practices
Everybody Benefits from Watching This. Even Better When Done as a Group!
-
- Regulatory Affairs Professionals Ensuring Compliance Standards
- Quality Assurance Specialists Managing Data Integrity Controls
- Compliance Officers Overseeing FDA 21 CFR Part 11 Requirements
- IT & System Administrators Handling GxP Computer Systems
- Clinical & Laboratory Managers Maintaining Electronic Records Compliance
- Validation & CSV Specialists Conducting Risk-Based System Validation
- Pharmaceutical & Biotech Professionals Working with Regulated Data
- Medical Device Manufacturers Implementing Audit Trail Best Practices
Instructor Profile
Carolyn (McKillop) Troiano has more than 40 years of experience in the tobacco, pharmaceutical, medical device and other FDA-regulated industries. She has worked directly, or on a consulting basis, for many of the larger pharmaceutical and tobacco companies in the US and Europe, developing and executing compliance strategies and programs. Carolyn is currently active in the Association of Information Technology Professionals (AITP), and Project Management Institute (PMI) chapters in the Richmond, VA area.
During her career, Carolyn worked directly, or on a consulting basis, for many of the larger pharmaceutical companies in the US and Europe. She developed validation programs and strategies back in the mid-1980s, when the first FDA guidebook was published on the subject, and collaborated with FDA and other industry representatives on 21 CFR Part 11, the FDA’s electronic record/electronic signature regulation.
