Validation documents, automated.
Generate GxP-compliant validation documents in minutes. AI-powered content generation with full audit trail, electronic signatures, and regulatory traceability.
Built for
14
Document Types
86%
Token Reduction
100%
Audit Coverage
Part 11
Compliant
Capabilities
Everything you need for CSV
From validation planning to summary reports — every document type, every compliance requirement.
14 Document Types
VP, URS, FRS, DS, IQ, OQ, PQ, RTM, Risk Assessments, Summary Reports, Configuration Reports, and Change Control records.
AI-Powered Generation
RAG-based content generation using your organization's SOPs and prior documents. Output matches your style and terminology.
Electronic Signatures
Part 11 compliant e-signatures with re-authentication, meaning statements, and immutable signature records.
Immutable Audit Trail
Hash-chain verified audit log capturing every action. Tamper-evident records with cryptographic integrity verification.
Content Library
Upload your SOPs and work instructions. The AI learns your organization's language and generates documents in your voice.
Change Control
Automatic detection of initial validation vs change control mode. Smart scoping of re-qualification activities.
Compliance
Built for regulators,
designed for teams.
Every feature is designed with regulatory compliance as the foundation, not an afterthought. From immutable audit trails to re-authentication for electronic signatures.
21 CFR Part 11 Electronic Records
Closed system controls, audit trails, and electronic signatures
EU Annex 11 Computerised Systems
Risk management, data integrity, and qualified infrastructure
GAMP 5 Risk-Based Approach
Software categorization and scalable validation lifecycle
ALCOA+ Data Integrity
Attributable, legible, contemporaneous, original, and accurate records
Validation Lifecycle
Validation Plan
Foundation
User Requirements
Requirements
Functional Requirements
Requirements
Risk Assessment
Risk Analysis
Installation Qualification
Verification
Operational Qualification
Verification
Performance Qualification
Verification
Traceability Matrix
Traceability
Summary Report
Closure
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