01 · Unique E-Signatures
Every sign-off is tied to one identity, one meaning, and one immutable timestamp. Reused credentials or shared logins cannot produce a valid signature.
21 CFR PART 11 · ELECTRONIC RECORDS, ELECTRONIC SIGNATURES
A logbook that can't be quietly edited after the fact.
10n20 eLog replaces the paper logbook on the bench with an electronic record your QA team can actually trust — e-signatures, a tamper-evident audit trail, and access controls built for a GxP inspection, not a startup demo.
Logbook: QC-BAL-014 — Analytical Balance (GxP)
● Cryptographic Chain of Custody Intact
// 21 CFR PART 11 CONTROLS
Every control an inspector expects to see.
Not "compliance-flavored" software — the specific controls Part 11 actually asks for, built in from the schema up.
02 · Tamper-Evident Audit Trail
Entries are appended, never overwritten. Corrections are new records that reference the original — the full history stays intact and visible.
03 · Equipment Training Gate
An operator cannot sign an entry for equipment they haven't been trained on. The system verifies SOP training status before unlocking the form.
04 · Account Lockout & Password Expiry
Failed-login lockout and forced password rotation configured directly to your site's SOP — not left as an insecure default.
05 · Dual-Witness Verification
Require second-person verification for critical steps like tare confirmation, standard preparation, and batch sign-off.
06 · Automated GxP PDF Export
Generate clean, cryptographically signed PDF reports for regulatory submission with a single click during audit inspections.
Deploy On-Premises or Private Cloud
Your next inspection shouldn't depend on a paper binder.
Docker deployment, dark & light mode for lab benches, and an audit trail your QA lead will actually want to show an FDA inspector.