GxP Compliance,
Agent-Ready.
Instant, sourced answers from your own SOPs,
validation protocols and regulatory guidelines.
  • 💬
    4 pharma analysis modesQA · Deviation · CAPA · Computer System Validation
  • 📋
    GxP audit trailEvery query logged — 21 CFR Part 11 & EU Annex 11 compliant
  • 🔒
    Private knowledge baseYour documents stay in your namespace — never shared
  • 🤖
    MCP-readyConnect directly from Claude AI, Claude Code, and agent workflows
Built by LLMOps.Pro · ComplianceRAG v1.4.0 · GAMP5 Category 4
Enter your personal API key to access your compliance workspace.

Each key is tied to a verified user identity, satisfying the individual accountability requirements of 21 CFR Part 11 and EU Annex 11 for electronic records.

Keys can be provisioned directly or linked to your organisation's SSO / Identity Provider for centralised access control.

Contact your system administrator to obtain yours.

Request a free demo key
ComplianceRAG v1.4.0
Ask a Compliance Question
Sources
Upload Document
📄
Document
→
🔢
Parse
→
✂
Chunk
→
🛠
Embed
→
📄️
Index
→
✓
Ready

Click to browse or drag & drop a file here

PDF, DOCX, XLSX, TXT supported

Audit Log
Timestamp Mode User Query FB Chain Ans. Hash
API Keys
UserNamespaceTierStatus Queries/dayUsed totalExpiresActions
Create Key
GAMP5 Category 4 — Configured Product
① Validation Plan

Generate and approve VP-CRAG-001 before drafting any qualification protocol.

VP-CRAG-001 Validation Plan — defines scope, approach, responsibilities, and schedule Not Started Document
② Protocol Drafts — Review & Approve Before Execution
🔒 Each protocol draft must be reviewed and signed off by QA before execution. Generate, edit if needed, approve, then execute.
IQ-CRAG-001 Installation Qualification — verifies correct installation of all components Not Started
OQ-CRAG-001 Operational Qualification — verifies all functional requirements (33 test cases) Not Started
PQ-CRAG-001 Performance Qualification — fitness for use with client's own document library (manual execution) Not Started Manual
③ Evidence Reports & Protocol Exports
🔒 Planned for v1.5 — IQ/OQ execution and document approval require an ERES-compliant workflow (21 CFR Part 11 / EU Annex 11). Until then, run IQ/OQ from the CLI and manage formal sign-off through your DMS/QMS.

CLI commands:  compliancerag validation run-iq --tester "Name" --environment validation  /  run-oq
④ Validation Report

Generate VR-CRAG-001 after all protocols are complete. IQ/OQ evidence results are auto-populated.

VR-CRAG-001 Validation Summary Report — formal closure document for the validation project Not Started Document
Behavioral Contract — GxP Governance
Loading…
System Status

Available Modes