Atachi NGIMES eLogbooks
The Digital Compliance Platform for Regulated Life-Sciences Manufacturing
Designed for FDA 21 CFR Part 11 and EU Annex 11
Transform Compliance from Risk to Competitive Advantage
Whether you're manufacturing pharmaceuticals, biologics, medical devices, or cell therapies, Atachi eLogbooks build in Part 11 audit trails, e-signatures and data-integrity controls.
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
Paper systems are a compliance liability you can't afford.
- Designed for FDA 21 CFR Part 11 and EU Annex 11
- Complete audit trails
- Electronic signatures with controls
- Audit trail retrievable on demand
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
Designed for FDA 21 CFR Part 11 and EU Annex 11.
- 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 DemoTrusted by Life Sciences Leaders
We went from 6 FDA observations on documentation to zero in our next inspection. The ROI was immediate.
Finally, DHRs that don't require an archaeology degree to complete. Reduced documentation time by 60%.
The only system that could handle our patient-specific workflows without customization.
Frequently Asked Questions
Typical implementations range from 6-8 weeks for a single site to 3-6 months for multi-site deployments. Our platform and proven methodology ensure rapid deployment without compromising quality.
Yes. Many customers manufacture combination products or have diverse portfolios. Our unified platform maintains segregation while enabling efficiency across all product types.
An IQ/OQ/PQ validation pack and audit support are included.
We use AES-256 encryption and provide role-based access control.
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 build in Part 11 audit trails, e-signatures and data-integrity controls.
Or call us: +1 (408) 839-1743