RCAMate™
Root Cause Analysis for Regulated Industries
Transform your CAPA lifecycle with structured, auditable, AI-augmented investigations. Built by certification auditors for Life Science, Pharma, and Medical Device companies.
The CAPA Compliance Challenge
CAPA-related citations consistently rank among the top FDA findings. Manual processes create audit vulnerabilities.
FDA 483 Citation
CAPA is the most cited FDA observation category
Avg. CAPA Cycle
Industry average for CAPA closure in pharma
Incomplete RCAs
Of investigations lack proper root cause depth
Cost per Warning Letter
Average remediation cost for FDA warning letters
Platform Capabilities
Everything you need for regulatory-grade RCA
5 AI-Powered RCA Methods
5 Whys, Ishikawa Fishbone, Cause Tree, Affinity Diagram, and Swiss Cheese Model with interactive visual diagrams and AI confidence scoring.
Strategic Analysis Suite
AI-generated PESTEL, SWOT with TOWS actions, Stakeholder Analysis with Power-Interest Matrix, and Christensen's Disruptive Innovation framework.
FMEA Risk Assessment
Severity, Likelihood, Detectability scoring per CAPA action. RPN calculation with current vs. residual risk comparison.
AI Change Control
Auto-generates change controls from control plans across 8 categories with impact assessment, approval routing, and validation requirements.
Organization Context
Upload policies, SOPs, org charts, and quality manuals. AI customizes all analyses to your organization's specific regulatory context.
Audit-Ready Reports
Generate comprehensive CAPA PDF reports with document control headers, investigation summaries, root cause findings, and approval signatures.
GxP Governance
Document control codes, digital print stamps, complete audit trail, role-based access, and 21 CFR Part 11 compliance features.
Witness Statements
Capture and manage witness accounts linked to cases with full traceability and chain-of-custody tracking for thorough investigations.
Regulatory Alignment
Built for regulated industries with clause-level compliance mapping
ISO 13485:2016
Medical device quality management system CAPA requirements
- 8.5.2 — Corrective Action
- 8.5.3 — Preventive Action
- 4.2.4 — Control of Records
- 8.2.2 — Complaint Handling
ISO 9001:2015
Quality management system requirements for any organization
- 10.2 — Nonconformity & Corrective Action
- 10.3 — Continual Improvement
- 9.1.3 — Analysis & Evaluation
- 7.5 — Documented Information
FDA 21 CFR Part 820
Quality System Regulation for medical device manufacturers
- 820.90 — Nonconforming Product
- 820.198 — Complaint Files
- 820.40 — Document Controls
- 820.184 — Device History Record
ICH Q10 / EU GMP
Pharmaceutical quality system and GMP requirements
- 3.2 — CAPA System
- 3.2.4 — Change Management
- 1.8 — Knowledge Management
- Annex 15 — Qualification & Validation
Configured software with full IQ/OQ/PQ validation readiness
Electronic records & signatures with ALCOA+ data integrity
Computer System Validation & Assurance documentation support
Industries Served
Experience RCAMate with a Free Demo
Get hands-on with AI-powered root cause analysis. Explore the platform with limited capabilities for 7 days — no credit card required.
Need full access? Contact us at Muhammad@fahmyconsulting.com or Contact us
Why RCAMate
Built by Auditors
Designed by certification auditors who understand FDA expectations and regulatory requirements for CAPA investigations.
AI Confidence Scoring
Every AI-generated analysis includes confidence scoring so you know when to trust AI recommendations.
Audit Ready
Complete audit trails, documented evidence, and compliance reports ready for FDA and internal auditors.
Rapid Deployment
Deploy in days, not months. Start your free trial immediately and be operational within a week.
Data Control
Your CAPA data stays under your control. On-premises deployment options available for high-security environments.
Expert Support
Support from quality professionals who understand CAPA challenges and regulatory landscape.
Ready to Transform Your CAPA Process?
Start your free 7-day trial today. No credit card required. Experience AI-powered root cause analysis built for regulated industries.