2021 - The 6 Most Common Problems in FDA Software Validation and Verification

Which data and systems are subject to 21 CFR Part 11 and Annex 11
Why compliance makes good business sense.
Details of FDA regulations/system features as applied to software: security, audit trails, electronic signatures.
Requirements for local, SaaS, and cloud hosting
The 6 Most Common Problems in FDA Software Validation & Verification.
Strategies on how to avoid the most common problems.
Advice on successful validation project staffing.
Avoid 483 and Warning Letters