21 CFR Part 11 · Electronic Records · Electronic Signatures · EU Annex 11 · Audit Trail · Non-repudiation · Data Integrity · ALCOA+ · Access Control · Password Policy · Session Management · 21 CFR Part 11 · Electronic Records · Electronic Signatures · EU Annex 11 · Audit Trail · Non-repudiation · Data Integrity · ALCOA+ · Access Control · Password Policy · Session Management ·
GxP Compliance · GAMP 5 · 21 CFR 11.10 · Validation · IQ / OQ / PQ · Tamper-Evident · Computerised Systems · Regulatory Submission · Lifecycle Management · Change Control · GxP Compliance · GAMP 5 · 21 CFR 11.10 · Validation · IQ / OQ / PQ · Tamper-Evident · Computerised Systems · Regulatory Submission · Lifecycle Management · Change Control ·
System Status
Audit TrailImmutable · Always ON
Auth Method2-Component E-Sign
SessionAuto-timeout: 5 min
EncryptionAES-256 · TLS 1.3
21 CFR Part 11 · EU Annex 11
ERES Manager
HASTAKSHAR · Electronic Records & Signatures
🔒 Encrypted
📋 Audit Logged
✓ 21 CFR 11
⚡ 2-Factor