Q. Please tell us about yourself. What brought you to your current position?
With over 25 years of experience in computer systems validation (CSV), data integrity, software quality assurance, and IT regulatory compliance within the life sciences industry, I’m a results-driven professional. For more than 15 years, I’ve worked in process and continuous improvement. I, therefore, possess an in-depth understanding of FDA 21 CFR Part 11 Electronic Records and Electronic Signatures, with a track record of successful data integrity remediation efforts.
I’ve performed various types of computer systems validation including, laboratory systems, clinical software, enterprise-wide systems, and manufacturing systems in life sciences.
My bachelor’s degree is in electronics engineering from Hacettepe University, Turkiye, and my computer systems analyst degree is from Humber College. Additionally, I hold an ASQ Six Sigma Green Belt certification (CSSGB) and a PMP® certification from the Project Management Institute—they bolster my leadership capabilities and empower me to manage my teams.
Q. What is your favorite part of the work you’ve done in this field?
Helping companies with regulatory compliance and ensuring they succeed in their field in CSV and data integrity requirements is my favorite part. Lowering costs and timeline of CSV projects and improving software quality while staying compliant with international regulatory requirements and standards including Part 11, EU Annex 11, MHRA, GAMP5, PIC/S, and ICH is a bonus.
In my career, I have successfully presented and defended GxP CSV, data integrity program, and quality systems during regulatory audits (by the FDA, Health Canada, EMA, MHRA, etc.), internal corporate audits, and customer audits with NO observations. I would, therefore, like to share my experience supporting hundreds of audits with our clients.
Q. What is your talk about?
My talk is on ways to establish IT quality and compliance on laboratory equipment. Attendees will gain a clear understanding of critical requirements for lab equipment, including:
- FDA CFR Part 11 and EU Annex 11: Key regulatory frameworks.
- Electronic Data Integrity Requirements: What’s essential for laboratory systems compliance.
- Principles and Risks: Safeguarding your lab’s data integrity.
- Practical strategies to meet data integrity regulations effectively.
The audience may also learn how to implement electronic data integrity principles in their lab operations, identify and mitigate data integrity risks, and develop actionable strategies to align with global regulatory standards.
Q. Why do you think it’s important to discuss this topic with our audience?
This topic is crucial because it addresses the core compliance requirements in the life sciences industry, particularly with GxP CSV, data integrity, and quality systems. Researchers and professionals in this field should understand these practices to ensure their work meets the strict regulatory standards set by the federal and international authorities.
The session is highly relevant as organizations presently face increasing scrutiny from regulators, especially during audits. Sharing real-world examples of successfully navigating audits without receiving observations provides invaluable insights that can help companies avoid costly mistakes, mitigate risks, and streamline their processes.
Esra brings over 25 years of experience in computer systems validation, IT quality and compliance in the life sciences industry. Her expertise includes FDA 21 CFR Part 11 and EU Annex 11, risk-based validation, electronic records and signature, and data integrity. Esra holds ASQ—Six Sigma Green Belt certification—as well as Project Management Professional (PMP) certification from the Project Management Institute (PMI). She has a bachelor’s degree in electronics engineering from Hacettepe University and a computer systems analyst diploma from Humber College.
Register today for free to attend Esra’s and other insightful webinars at the 2025 Laboratory Quality and Compliance Week!
