GxP AI Assistant for CAPA, Audits & CTQF
Inspection-oriented GxP AI assistant for GCP and QA professionals. Designed in line with GAMP 5, ICH E6(R3) and 21 CFR Part 11 principles as a decision-support tool.
For enterprise teams with the premium Team Assistant (custom) option.
No credit card required. Full access to all validated workflows.
A Structured AI Workflow for GxP
Not a generic chatbot. Validated prompts with 3-phase CAPA generation, structured review, and audit finding workflows.
1. Was this a scheduled or unscheduled PI change?
2. Was the delegation log update missed entirely or delayed?
3. Any patient safety impact identified?
Why 1: Delegation log not updated → No automated reminder
Why 2: No reminder system → SOP lacks trigger mechanism
Why 3: SOP gap → Process written before PI turnover became frequent
Why 4: No oversight mechanism → QA review of PI changes not part of process
Why 5: No QA review → Site relied on PI self-reporting for delegation updates
Root Cause: SOP-GOV-003 lacks PI transition checklist with mandatory delegation log update trigger.
Do you agree with this analysis, or was the reason different?
Corrective Action: Revise SOP-GOV-003 to include PI transition checklist
Preventive Action: Implement automated delegation log reminders in CTMS
Effectiveness Check: Audit next 5 PI changes for delegation log compliance
CAPA Score: 11/12 (Strong)
Four Validated Modes. One AI.
Each workflow has validated prompts tested against real audit data and regulatory standards.
CAPA Generate
3-phase structured CAPA generation: clarification interview, root cause analysis (5 Whys / Fishbone), and full CAPA with scoring.
- Phase 1: Problem clarification interview
- Phase 2: RCA with 5 Whys / Fishbone
- Phase 3: Full CAPA with 12-point score
- Aligned with QARP Master Template
CAPA Review
Dual-mode review: Mode A verifies RCA then builds CAPA for single findings. Mode B scores full audit responses 0-12 with summary table.
- Single finding deep analysis (Mode A)
- Batch audit scoring 0-12 (Mode B)
- No attribution of intent without evidence
- Professional inspection-grade language
Audit Finding Generator
Generate inspection-ready GCP observations in seconds. Consistent grading and rationale aligned with EMA/FDA focus.
- Classification: Critical / Major / Minor
- Regulatory reference mapping
- Risk-based impact assessment
- Inspection-grade finding language
CTQ/CTQF Draft
Draft Critical to Quality Factors from your process descriptions, aligned with ICH E6(R3) quality management requirements.
- Process-to-CTQ mapping
- Risk factor identification
- E6(R3) aligned output
- Ready for QMS integration
Automatic Document Anonymizer
All documents are automatically anonymized before AI processing. Patient names, site identifiers, investigator details, and sponsor information are redacted in real time.
- Patient names and identifiers removed automatically
- Site and investigator details redacted
- Sponsor and study identifiers masked
- Original documents never stored
- GDPR and 21 CFR Part 11 compliant
Patient: John Smith
Site: London Royal Hospital
PI: Dr. Sarah Johnson
Study: XYZ-001-UK
Patient: [SUBJECT]
Site: [SITE-001]
PI: [INVESTIGATOR]
Study: [STUDY-ID]
Built for Regulated Industries
Every design choice reflects GxP thinking. Not just AI with a compliance label.
Decision Support Only
Human in the loop for all critical decisions. The AI drafts — you verify and approve.
GxP/GAMP-Aware Design
Logging, version awareness, clear intended use. Built with validation thinking from day one.
Automatic Document Anonymization
All uploaded documents are automatically anonymized before processing. No PII reaches the AI model.
Continuous Monitoring
In-app bug and inconsistency reporting feeds our internal AI deviation/CAPA process — no black box.
Start with a 7-Day Free Trial
Full access to all validated workflows. No credit card required.
AI Assistant Basic
- GxP-aware AI assistant
- Open prompt for QA/GCP questions
- Decision-support with logging
- Safe alternative to generic AI
- Automatic document anonymization
AI Assistant GxP Workflows
- Everything in Basic
- CAPA Generate (3-phase validated)
- CAPA Review (dual-mode)
- Audit Finding Generator
- CTQ/CTQF Draft Helper
- Automatic document anonymization
- Mini validation overview
Team Assistant
- Shared company workspace
- Customized workflows for your processes
- GAMP 5-aligned validation package
- Private server deployment
- Ready for regulatory inspections
7-day free trial on Basic and GxP Workflows plans. No credit card required.
Trusted by Regulated Industries
Built for pharma, biotech, medical devices, and CROs