Good Documentation Practices to Support FDA Computer System Validation
This session will address the specific way of documenting your computer system validation work to ensure it meets FDA requirements and can pass an inspection, also this webinar will help you understand the FDA's requirements for good documentation, including how to handle change control and the importance of audit trails, you will learn how to create and maintain good documentation that meets FDA compliance standards.
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As a "GxP" system, following Good Manufacturing, Laboratory and Clinical Practices, the computer system must be validated in accordance with FDA requirements. If electronic records and/or electronic signatures (ER/ES) are incorporated into the system, FDA's CFR Part 11 guidance on ER/ES must be followed. This webinar will help you understand the FDA's requirements for good documentation, including how to handle change control and the importance of audit trails.
We will also cover the importance of maintaining the documentation from every computer system validation effort in a "current" state. The system must be maintained in a validated state throughout its entire life cycle, and the accompanying validation documentation must also be maintained.
Why should you Attend:
FDA requires that all computer systems that handle data regulated by the Agency to be validated in accordance with their guidance on computerized systems. In 1997, 21 CFR Part 11 was issued to address electronic records and signatures, as many laboratories and other FDA-regulated organizations began seeking ways to move into a paperless environment.
This session will address the specific way of documenting your computer system validation work to ensure it meets FDA requirements and can pass an inspection. There are specific requirements that must be followed in order for the Agency to consider the documentation valid, and without following these, there is a great risk of invalidating work.
Areas Covered in the Session:
Who Will Benefit:
- Computer System Validation (CSV) and the System Development Life Cycle (SDLC) Methodology
- "GxP" - Good Manufacturing, Laboratory and Clinical Practices
- 21 CFR Part 11, Electronic Records/Electronic Signatures (ER/ES)
- Data Archival to ensure security, integrity and compliance
- Learn the requirements for documenting efforts related to systems governed by FDA
- Discuss the best practices for documenting computer system validation efforts, including requirements, design, development, testing and operational maintenance procedures
- Review examples of incorrect, incomplete, or otherwise inappropriate and non-compliant documentation and understand why these are not acceptable
- Learn how to prepare a procedure that will capture the best practices for FDA compliant documentation
- Discuss the importance of training as it relates to good documentation practices to ensure FDA compliance
- Information Technology Analysts
- Information Technology Developers and Testers
- QC/QA Managers and Analysts
- Analytical Chemists
- Laboratory Managers
- Automation Analysts
- Computer System Validation Specialists
- GMP Training Specialists
- Business Stakeholders/Subject Matter Experts
- Business System/Application Testers
- Clinical Data Managers and Scientists
- Quality Managers, Chemists and Microbiologists
- Regulatory Affairs Personnel
- Consultants in the Life Sciences and Tobacco Industries
- Interns Working at the Companies Listed Above
Carolyn (McKillop) Troiano has more than 35 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.