FDA-Compliant Lab Notebooks for Drug Discovery Through Manufacturing
From early-stage research to commercial manufacturing, the ELN Suite provides the documentation infrastructure pharma labs need — FDA 21 CFR Part 11 compliance, automated audit trails, electronic signatures, and complete data integrity.
What Pharma Labs Deal With Every Day
Regulatory Complexity
Navigating FDA 21 CFR Part 11, EU Annex 11, and ICH guidelines while maintaining research velocity. Manual compliance processes slow everything down.
Data Integrity Under Scrutiny
Every data point must be attributable, legible, contemporaneous, original, and accurate. Paper notebooks and spreadsheets create gaps auditors find.
Disconnected Systems
Instrument data in one place, notebooks in another, protocols somewhere else. Piecing together a complete audit trail across systems wastes hours.
IP Protection & Chain of Custody
Patent claims require timestamped proof of invention. Incomplete records can cost millions in IP disputes.
Purpose-Built for Pharma Workflows
FDA 21 CFR Part 11 Compliance
Purpose-built compliance with electronic records and signatures requirements. Automated audit trails capture every action — who did what, when, and why. Biometric electronic signatures with meaning statements satisfy even the most rigorous inspections.
- Tamper-proof audit trails with SHA-256 hashing
- Electronic signatures with biometric authentication
- Meaning statements and witness countersigning
- Automatic session management and access controls
ALCOA+ Data Integrity
Every piece of data in the ELN Suite is automatically Attributable, Legible, Contemporaneous, Original, and Accurate — plus Complete, Consistent, Enduring, and Available. No manual effort required.
- Automatic timestamping on every entry and edit
- Immutable original records with full version history
- Structured data entry preventing incomplete records
- Complete traceability from raw data to final report
Instrument Integration & Automation
Connect lab instruments directly to the ELN Suite. Data flows automatically from HPLC, mass spec, plate readers, and more — eliminating transcription errors and ensuring traceability.
- Direct connectivity with major instrument vendors
- Automated data capture and file import
- Structured workflows for method validation
- Equipment qualification documentation
Regulatory Reporting & Analytics
Generate audit-ready reports instantly. Track QC trends, batch records, and stability data with built-in analytics. Publication-ready exports for regulatory submissions.
- One-click compliance report generation
- QC trend analysis with automated alerts
- Batch record templates and tracking
- Export in FDA submission-ready formats
Full-Text Search Across Everything
Find any experiment, protocol, or data point in seconds. Search across notebooks, files, PDFs, and even scanned documents. Advanced filters by project, author, date, and status.
- OCR-powered search inside PDFs and images
- Cross-reference experiments to protocols and SOPs
- Instant previews without opening documents
- Saved searches and smart filters
...89.2% binding at 500nM for ELN-4821...
...fluorescence polarization method for ELN-4821...
...384-well format, compound ELN-4821 dose response...
Regulations We Cover
Not generic “we support compliance” — specific, deep regulatory coverage.
FDA 21 CFR Part 11
Electronic records and signatures for pharmaceutical manufacturing and research
EU Annex 11
European requirements for computerized systems in GMP environments
ICH Q7 / Q10
Good Manufacturing Practice guidelines for active pharmaceutical ingredients
GLP / GMP
Good Laboratory and Manufacturing Practice standards for preclinical and production
ALCOA+
Data integrity framework enforced automatically across every workflow
USP <1058>
Analytical instrument qualification requirements
See How ELN Suite Fits Your Pharma Lab
Schedule a demo tailored to pharmaceutical workflows — from drug discovery documentation to GMP manufacturing records.
Personalized demo · No credit card required · Response within 1 business day