FDA Part 11 compliance involves so much more than e-signing documents and storing them securely.
Medical device RA/QA professionals focus so much on document creation and data collection that they sometimes overlook the importance of proper record maintenance and data integrity. This neglect often results in findings during FDA inspections.
In this instructor-led class, we will guide you through all facets of compliance with FDA 21 CFR Part 11 requirements governing electronic signatures and records. You’ll see excepts from several actual warning letters referencing data integrity, and review six common misconceptions that companies have about Part 11 compliance. Moreover, you’ll learn about the linkages with cybersecurity and validation in document and data management systems.
At the conclusion of this class you will understand why FDA places so much emphasis on computer system controls, how Part 11 ensures data integrity, the “predicate rules” related to electronic records, and your overall Part 11 obligations.
All attendees must have a basic familiarity with FDA 21 CFR Part 820. For a basic foundation in Medical Device Quality System, consider our FDA QSR and ISO 13485 Foundation Class.