21 CFR Part 11, FDA Guidance for Electronic Records and Signatures

21 CFR Part 11, FDA Guidance for Electronic Records and Signatures
Speaker - Carolyn Troiano
Duration - 90 Minutes
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The Webinar will ensure that the electronic record/electronic signature (ER/ES) capability built into FDA-regulated computer systems meets compliance with 21 CFR Part 11. This includes developing a company philosophy and approach, incorporating it into the overall computer system validation program, and plans for individual systems with this capability.
Learning Objectives
Understand what constitutes an electronic record and an electronic signature.
Learn about the FDA requirements for handling electronic records and electronic signatures using a computer system regulated by the FDA.
Learn about the FDA’s current thinking about technology and software development, and how this will impact the industry.
Learn about FDA’s current trends in compliance and enforcement related to 21 CFR Part 11.
Learn how to apply a consistent approach to validation for FDA-regulated computer systems.
Discuss the current state of the Computer System Validation (CSV) approach based on FDA requirements.
Learn about the System Development Life Cycle (SDLC) approach to validation and how this can be modernized through a more agile approach, including automated testing for continuous validation.
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