Atachi NGIMES eLogbooks

The Digital Compliance Platform Trusted by Life Sciences Leaders Worldwide

Pre-validated for FDA, EMA, and Global Regulatory Standards

FDA 21 CFR Part 11 Validated
EU Annex 11 Compliant
ISO 13485:2016 Certified
18+ Years in Life Sciences

Transform Compliance from Risk to Competitive Advantage

Whether you're manufacturing pharmaceuticals, biologics, medical devices, or cell therapies, Atachi eLogbooks eliminate compliance risk while accelerating your operations.

40% Faster Documentation

Industry studies show digital batch records save 22% of total man hours. Our customers typically see even better results.

  • Smart templates with auto-population
  • Guided workflows prevent errors
  • Mobile-first design for shop floor
  • Parallel review and approval

Reduced Compliance Risk

With 21% of FDA warning letters citing data integrity, paper systems are a compliance liability you can't afford.

  • Pre-validated for global regulations
  • Complete audit trails
  • Electronic signatures with controls
  • Inspection-ready in seconds

Rapid Batch Release

Transform multi-week paper processes into streamlined digital workflows that free up millions in working capital.

  • Review-by-exception dashboards
  • Electronic routing automation
  • Real-time visibility across sites
  • Instant batch genealogy reports

Tailored Solutions for Every Life Sciences Sector

From traditional pharmaceuticals to cutting-edge cell therapies, Atachi adapts to your unique requirements.

Small & Large Molecule Manufacturing

Complete batch record management for tablets, capsules, injectables, and APIs with built-in GMP workflows.

  • Multi-product facility support
  • Cleaning validation tracking
  • Equipment utilization optimization
  • Environmental monitoring integration

Regulatory Compliance

Pre-configured for FDA, EMA, MHRA, Health Canada, TGA, and PMDA requirements.

  • 21 CFR Parts 210/211 compliance
  • ICH Q7 for API manufacturing
  • Serialization readiness
  • Annual product review support

Calculate Your ROI

Enter your facility details to see your potential return on investment

See Atachi eLogbooks in Action

Get a personalized demo and discover how Atachi can transform your compliance operations

Schedule Your eLogbooks Demo

Trusted by Life Sciences Leaders

"

We went from 6 FDA observations on documentation to zero in our next inspection. The ROI was immediate.

Quality Director
Top 20 Pharma Manufacturer
"

Finally, DHRs that don't require an archaeology degree to complete. Reduced documentation time by 60%.

Operations Manager
Medical Device Manufacturer
"

The only system that could handle our patient-specific workflows without customization.

VP Manufacturing
Cell Therapy Pioneer

Frequently Asked Questions

How long does implementation really take? +

Typical implementations range from 6-8 weeks for a single site to 3-6 months for multi-site deployments. Our pre-validated platform and proven methodology ensure rapid deployment without compromising quality.

Can Atachi handle both drug and device documentation? +

Yes. Many customers manufacture combination products or have diverse portfolios. Our unified platform maintains segregation while enabling efficiency across all product types.

What about validation requirements? +

Our pre-validated platform comes with complete IQ/OQ/PQ protocols. We provide all documentation needed for regulatory compliance, typically reducing validation time by 70%.

How do you ensure data security? +

We maintain SOC 2 Type II certification, use AES-256 encryption, provide role-based access control, and offer regional data residency options to meet your specific requirements.

Can we start with just one department? +

Absolutely. Most customers start with QC labs or packaging. Our modular approach lets you prove value in one area before expanding across the facility.

Ready to Transform Your Compliance?

Schedule a demo and see how Atachi eLogbooks can eliminate compliance risk while accelerating your operations.

Or call us: +1 (408) 839-1743