21 CFR Part 11 in Latin America
When Part 11 applies to LATAM trials and integration with local regulations.
LATAM context
Most LATAM countries (Brazil ANVISA, Mexico COFEPRIS, Argentina ANMAT, Colombia INVIMA) have regulations on electronic records in trials but less specific than Part 11.
Part 11 effectively applies when the study is submitted to the FDA, which occurs frequently for parallel approvals.
Common scenarios
- •Multinational trials with US site
- •Parallel registration with FDA after local approval
- •US sponsors running in LATAM
Coverage
- ✓Same technical infrastructure cross-jurisdiction
- ✓Part 11 docs in Spanish
- ✓UTC timestamps for country-reconciliation
FAQ
Does ANVISA require Part 11?
Not directly. ANVISA has its own guides (RDC 9/2015 et al.). Part 11 applies if also submitting to FDA.
Need specific documentation?
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