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FDA · CDER / CBEREU CTR21 CFR Part 11GAMP-5ICH M11AWS healthcare-gradeHIPAA BAA

21 CFR Part 11 audit chain — tamper-evident to genesis
GAMP-5 Category 5 validation evidence
WebAuthn 2FA on every electronic signature
AES-256 at rest · TLS 1.2+ in transit

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21 CFR Part 11GAMP-5 Cat 5HIPAA BAA

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