Indianapolis – September 16, 2026 -- Crystal Risotti, Senior Manager of Validation in Quality Assurance at CTI, has been named a Pinnacle Professional of the Year by The Inner Circle for her three-decade career in information technology quality assurance and regulatory compliance across pharmaceuticals, medical devices and clinical laboratories.
Risotti built her career from clinical trial lab work in 1990 to enterprise-wide compliance leadership
Risotti entered the pharmaceutical industry in 1990 as a clinical trials laboratory worker before moving through customer service, project management, training and Tier 4 help desk roles. She later specialized in software development life cycle consultation, 21 CFR Part 11 compliance, and electronic quality management system implementation, working remotely from Indianapolis, Indiana while based at CTI's Covington, Kentucky office.
She led a global eQMS rollout and introduced AI-driven compliance procedures
Among her documented achievements, Risotti directed the end-to-end implementation of an electronic quality management system supporting global clinical development operations. She developed scalable, risk-based validation and compliance programs, strengthened adherence to 21 CFR Part 11 and related frameworks, and introduced artificial intelligence procedures aimed at improving both compliance accuracy and operational efficiency.
Committee work and mentoring extended her influence beyond individual projects
Risotti has served on multiple Quality System Documents Committees, contributing to governance frameworks that shape regulatory documentation practices. She has also built and led compliance teams, mentoring staff in quality assurance disciplines, and has received prior recognition, including an Influential Woman citation for her healthcare and technology industry contributions.
Risotti holds a 2019 business administration degree and targets a director-level role
She earned a Bachelor of Business Administration from Indiana University in 2019. Risotti has stated her intention to pursue a Director-level position, continuing to strengthen quality systems, regulatory compliance and innovation initiatives across the healthcare technology sector.