Title 21 CFR Part 11 is the part of Title 21 of the Code of Federal Regulations that establish the Food and Drug Administration (FDA) regulations on electronic records and electronic signatures (ERES).
Part 11 applies to records in electronic form that are created, modified, maintained, archived, retrieved, or transmitted under any records requirements set forth in Agency regulations. Part 11 also applies to electronic records submitted to the Agency under the Federal Food, Drug, and Cosmetic Act (the Act) and the Public Health Service Act (the PHS Act), even if such records are not specifically identified in Agency regulations.
Attend our free, live 45-minute webinar to learn about how FDA CFR Part 11 compliance can be achieved by following the best practices developed by our speaker and the tools that will help you achieve continuous compliance.
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Srini is a results-driven security and compliance professional with over 20 years of experience supporting, leading, and managing global IT security, compliance, support, and risk assessment in fortune 100 companies.
- Entrepreneur and MBA with demonstrated expertise in managing finances, marketing, social media, search engine optimization, and other key technology skills required for running a next generation business.
- Strong track record in implementing initiatives that help business groups operate scalable, secure, and efficient IT, with a solid process-oriented approach.
- Proven history of bringing in projects on time and on budget while overseeing high-performance teams, boosting technical and business expertise and maintaining morale.
- Active in several community groups including Rotary International, The Indus Entrepreneurs (TIE), and Council for Entrepreneurial Development of NC.
- Driven by the challenge and the opportunity for development, thriving in diverse, fast-paced settings.