With over 12 years of significant experience in the pharmaceutical and medical device industries, Ms. Lalitha Amarapalli has consistently excelled in roles focused on Computer System Validation (CSV), Data Integrity Compliance, Software Quality Assurance, and compliance adherence under rigorous U.S. FDA and ICH regulations. Her unwavering dedication and deep technical expertise have profoundly shaped compliance management and validation practices within highly regulated healthcare environments.

Throughout her career, she has skilfully navigated complex regulatory landscapes, successfully leading critical validation projects. Her comprehensive expertise spans all stages of computerized system lifecycle management – Planning, Requirements Analysis, Design, Coding, Testing, Deployment, Maintenance, and Retirement. One of her recent standout initiatives includes leading a comprehensive compliance and remediation project specifically aimed at enhancing 21 CFR Part 11 adherence, fortifying data integrity. Similarly, she introduced the CI/CD (Continuous Integration and Continuous Delivery) software delivery process, which helped the teams achieve faster development, faster releases, early bug detection, and improved software quality.

Academically, she holds a Master of Science degree in Analytical Chemistry from Governors State University, which laid a strong foundation in analytical and problem-solving capabilities crucial to her professional success. Additionally, her credentials as a Certified Software Quality Engineer from the American Society for Quality further solidify her ability to deliver superior validation and compliance outcomes.

Beyond her technical capabilities, she has demonstrated exceptional leadership qualities, effectively supervised cross-functional teams, and mentored emerging professionals in compliance and validation. Dedicated to quality assurance and innovation, she is a trusted expert in compliance methodologies and solutions. As she progresses in her professional journey, she is well-positioned to significantly influence and advance compliance and validation practices across the pharmaceutical and medical device industries.