2020 - Best Practices in Preparation for an FDA Computer System Audit

Computer System Validation (CSV) and the System Development Life Cycle (SDLC) Methodology
“GxP” – Good Manufacturing, Laboratory and Clinical Practices
21 CFR Part 11, Electronic Records/Electronic Signatures (ER/ES)
Data Archival to ensure security, integrity and compliance
Validation Strategy that will take into account the system risk assessment and system categorization (GAMP V) processes
Recent FDA findings for companies in regulated industries
The resources, documentation and room preparation necessary to adequately prepare for inspection
Q&A