Documents
AI-native document management for pharmaceutical manufacturing. Every document vectorised. Every SOP compliance-checked. Every change tracked.
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Documents
AI-native document management for pharmaceutical manufacturing. Every document vectorised. Every SOP compliance-checked. Every change tracked.
Schedule a demo
Built for Regulated Document Control
Every document vectorised on upload. Every SOP checked against FDA data. Every change propagated automatically.
Leucine Documents is an AI-native document management system built for pharmaceutical manufacturing. Documents are vectorised the moment they're uploaded, enabling semantic search, AI-powered authoring, and automated compliance checking against FDA guidances, 21 CFR Part 11, and EU GMP Annex 11. When regulations change, affected documents are flagged automatically. When SOPs are revised, training and change control workflows are triggered without manual intervention.
AI-Powered Authoring
Generate SOPs, work instructions, and controlled documents from templates, regulatory references, and existing documentation — with AI that understands pharmaceutical language and GMP requirements.
Content Generation.
AI drafts complete SOPs from templates and existing documentation, pre-populated with process-specific language and regulatory references.
Regulatory Language.
Built-in awareness of FDA, EMA, and ICH terminology ensures generated content meets regulatory expectations from the first draft.
Template Library.
Configurable templates for SOPs, batch records, protocols, and specifications — version-controlled and reusable across sites.
Multi-Format Output.
Generate documents in PDF, Word, and HTML formats with consistent formatting, headers, and approval blocks.
Vectorised Document Intelligence
Every document is automatically vectorised on upload — enabling semantic search, AI-powered reasoning, and cross-document intelligence across your entire document library.
Automatic Vectorisation.
Documents are indexed and vectorised on upload — no manual tagging or classification required.
Semantic Search.
Search by meaning, not just keywords. Find relevant content across SOPs, protocols, and specifications using natural language queries.
Contextual Results.
Search results are ranked by relevance with highlighted excerpts and source traceability back to the original document and version.
Cross-Document Linking.
AI identifies related content across documents — surfacing dependencies, contradictions, and opportunities for harmonisation.
FDA Data-Backed SOP Compliance Check
AI checks your SOPs against FDA guidance documents, 21 CFR Part 11, EU GMP Annex 11, and ICH guidelines — not just formatting validation, but regulatory substance verification.
Regulatory Cross-Referencing.
Automatically maps SOP content against applicable FDA guidances, 21 CFR regulations, and EU GMP Annex 11 requirements.
Gap Detection.
Identifies missing regulatory requirements, incomplete procedures, and areas where SOP language falls short of current guidance.
Compliance Scoring.
Each document receives a compliance score based on coverage of applicable regulatory requirements — quantifying readiness at a glance.
Remediation Suggestions.
AI recommends specific language, sections, and references to add — with citations to the relevant regulatory source.
Automated Non-Compliance Notifications
When regulations change, affected documents are flagged automatically. Real-time monitoring of FDA, EMA, and ICH updates triggers review workflows before your SOPs fall out of compliance.
Regulatory Change Monitoring.
Continuous monitoring of FDA guidances, EMA guidelines, and ICH updates for changes that affect your document library.
Affected Document Identification.
AI maps regulatory changes to specific documents, sections, and clauses that require review or update.
Auto-Triggered Review.
Review workflows are initiated automatically when a regulatory change impacts a controlled document — no manual tracking required.
Escalation Workflows.
Configurable escalation rules ensure high-impact regulatory changes reach the right stakeholders with appropriate urgency.
Document Lifecycle Management
Full lifecycle control from draft through review, approval, effective use, periodic review, and retirement — with complete version history, e-signatures, and audit trail at every stage.
Status-Driven Workflows.
Documents move through configurable lifecycle states — Draft, In Review, Approved, Effective, Periodic Review, Superseded, Retired.
Version Control.
Complete version history with side-by-side comparison, change highlighting, and the ability to trace any modification back to its author.
Electronic Signatures.
Full 21 CFR Part 11 compliant e-signatures at every approval stage, with automatic identity verification and meaning statements.
Archival Policies.
Automated retention and archival policies ensure documents are preserved, retrievable, and compliant with regulatory retention requirements.
Smart Review & Approval Routing
Intelligent routing assigns the right reviewers based on document type, department, content classification, and regulatory requirements — accelerating review cycles without compromising compliance.
Auto-Assigned Reviewers.
Reviewers are assigned automatically based on document type, content area, and departmental responsibility matrices.
Parallel & Sequential Workflows.
Configure parallel reviews for speed or sequential reviews for dependency — or combine both in multi-stage approval chains.
Deadline Tracking.
SLA-driven review timelines with automated reminders, escalation rules, and overdue notifications to prevent bottlenecks.
Approval Audit Trail.
Every review comment, approval decision, and routing action is recorded with timestamps, user identity, and electronic signatures.
Training Integration
When an SOP is revised, training assignments are triggered automatically. Connected to the Learning module, Documents ensures every affected operator is trained on the latest version before it takes effect.
Change-Triggered Assignments.
SOP revisions automatically generate training assignments for all personnel whose roles are affected by the change.
Read-and-Acknowledge.
Simple read-and-acknowledge workflows for minor revisions — with quiz-based assessments for substantive content changes.
Completeness Dashboards.
Real-time visibility into training completion rates by document, department, and site — surfacing gaps before they become audit findings.
Learning Module Integration.
Deep integration with the LeucineOS Learning app for structured training programmes, competency tracking, and re-certification scheduling.
Change Control Integration
Document updates automatically initiate change control workflows. Impact assessments, approval chains, and regulatory classifications are linked end-to-end — ensuring no change goes untracked.
Impact Assessment.
AI-assisted impact analysis identifies all downstream effects of a document change — affected processes, equipment, training, and regulatory filings.
Cross-System Traceability.
Full traceability from the change request through document revision, training update, and implementation verification.
Approval Chains.
Change control approval workflows are linked to document approval — ensuring both processes move in lockstep with complete audit trail.
Regulatory Classification.
Changes are automatically classified by regulatory impact — major, minor, or administrative — with appropriate review workflows for each.
Connected across the platform
See how Documents sends and receives signals across every LeucineOS app.
Documents
Signal cascade
Triggered by
Change approval updates affected SOPs
FDA guidance update triggers SOP review
Triggers
SOP revision auto-assigns training
Document update initiates change control
Click again or press Esc to close
Documents
Signal cascade
Triggered by
Change approval updates affected SOPs
FDA guidance update triggers SOP review
Triggers
SOP revision auto-assigns training
Document update initiates change control
Click again or press Esc to close
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Running in production at 400+ GMP facilities
New Jersey, USA
Automated HBEL-based cleaning validation with risk-based protocol generation, ensuring continuous FDA and EMA compliance.
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See document control run on LeucineOS.
AI-native SOP authoring, vectorised search, and FDA data-backed compliance checks. Every document version-controlled with 21 CFR Part 11 e-signatures.