xLab▪Genesis/Compliance
Compliance by design

What auditors care about,
built in by default

One audit system across the platform, covering access control, e-signatures, controlled numbering and audit trails, with complete audit reports that greatly shorten system validation.

Screen: audit trail query
Regulations

Standards xLab▪Genesis follows

Data integrity and information security are both covered, and the architecture is built to the relevant international standards.

21 CFR Part 11ALCOA+ data integrityGMP / GxP · EU Annex 11ISO 27001 Annex AValidation support (IQ / OQ) (optional module)
Data Integrity & Compliance

Security & access control

Suitable for API and formulation plants, testing institutions, CRO/CDMO project contracts, and any company with an R&D or testing unit.

Tamper-evident audit trail hash chainE-signature bound to content via SHA-256RBAC role × permission matrixMFA two-step verification (TOTP)bcrypt password protectionAutomatic logout on idleDaily backup / restore testEd25519 signed licensing
Audit Center

What auditors ask for,
delivered in one click

An independent audit area built for the QA department, with duties and permissions kept separate.

01Audit trail review

Every activity on the platform, such as logins, work performed and content changes. QA can filter by action, item, date or person and export an audit report.

02ELN version review

Any ELN record can be reviewed on its own, including content, signature trail and version comparison.

03System integrity report

xLab▪Genesis can produce a full system integrity report at any time.

04Document verification

Controlled PDFs carry a verification code on export, and authenticity can be confirmed in xLab▪Genesis.

Architecture

Architecture & requirements

01Deployment

Hosted with a major server provider. Nothing to install: connect straight from the browser, with multi-user access. (Taiwan: hosted on local Google servers, so international link outages do not affect service.)

02Data & backup

Automatic daily backup and restore testing, with UUID-sharded attachments and SHA-256 integrity checks.

03Confidentiality

Single sign-on, with a dedicated server for every subscribing customer.

04Security baseline

bcrypt password protection, lockout after failed logins, idle logout, SHA-256 fingerprint chain and Ed25519 licence signatures.

05Information security

Outbound connections can be switched off item by item to match your security policy; with search and AI disabled the system runs entirely inside your network. Logins, permission changes and key operations are all recorded for your security team to review.

06Maintenance

Round-the-clock backup and restore verification, with a system audit report available at any time.

Book a demo

Bring your reactions and samples: a 30-minute live test

Please include your company, contact person, phone and expected number of users; we will arrange a demo at your site.