ProVal AI
ProVal AI
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Scaling Compliance with Intelligence and Precision
ProVal AI is the first AI Thought Partner for Validation and Quality, transforming how regulated industries like medtech, pharma, and biotech approach compliance.
With Pendoah as its technology partner, ProVal AI re-engineered the entire validation lifecycle, achieving:
faster validation cycles
fewer review iterations
compliance cost savings
consultant capacity expansion
Market Context
The global market for compliance and quality management software is projected to exceed $20 billion by 2030.
For small and mid-sized medical device companies, annual compliance costs typically range from $250,000 – $500,000, and 45% of FDA audit failures stem from inadequate documentation.
This gap between regulatory pressure and operational capacity presented a clear opportunity: build an intelligent, audit-defensible system that delivers automation without sacrificing control or security.
ProVal AI entered the market precisely to meet that need, with Pendoah providing the technical and strategic architecture behind it.
The Challenge
It takes weeks to prepare documents, costs heavily due to consultants, risks errors that cause audit failures, and exposes sensitive data to security threats.
- Weeks to draft validation documents.
- High consultant costs.
- Errors leading to audit failures.
- Security concerns around sensitive data.
The Vision
Designed for SMBs
We focus on AI solutions for SMB where security, compliance, and ROI are non-negotiable.
Business + Technical Alignment
We balance executive clarity with engineering depth. You’ll have a board-ready business case and a technical blueprint.
Compliance Built-In
Our strategies map directly to regulated industries in North America.
From Strategy to Production
Unlike firms that stop at the slide deck, we ensure your roadmap accelerates into production-ready results.
Before & After
Before ProVal AI
- Weeks to generate validation documents
- Dependence on costly consultants.
- High error rates and audit stress.
- Opaque, inconsistent compliance practices.
After ProVal AI
- Hours to generate documents.
- Lower costs with AI + expert templates.
- Traceable, defensible compliance logic.
- Confidence during FDA/ISO audits.
User Personas
QA Leader
Needed faster documentation and audit confidence.
Startup Founders
Sought compliance readiness without six-figure consultant spend.
Consultants
Wanted to scale client throughput without quality loss.
SMB Teams
Required traceability and role-based access across global systems.
Implementation Journey
01
Discovery & Requirement Mapping
Pendoah conducted user research with regulatory professionals to define automation pain points.
02
Architecture Design
React.js frontend, Node.js + Python backend, Azure SaaS deployment for HIPAA/SOC-2 alignment.
03
AI Integration
GPT-powered chatbot combined with RAG-based domain logic for precise validation guidance.
04
Compliance Alignment
Built to FDA 21 CFR Part 11 and EU MDR specifications with encryption and access logging.
05
Deployment & Scaling
Launched under a multi-tier subscription model with continuous feedback loops and monitoring dashboards.
Design Principles
Privacy-First
Encrypted access and zero-data retention across every interaction.
Audit-Defensible
Hybrid AI models and rule logic to ensure full decision traceability.
Simplicity
Guided, focused workflows replace cluttered, complex dashboards.
Scalable
Built to perform seamlessly from startup scale to large SMB.
Human-in-the-Loop
All templates and recommendations vetted by QA experts.
Features & Modules
Validation Document Generator
Auto-creates plans, risk files, and test reports.
Risk Assessment Engine
Conducts hazard scoring and traceability mapping.
Consulting Chatflow
Interactive AI assistant for real-time compliance guidance.
Template Library
Editable, human-approved documentation assets.
Audit Logs & Security Layer
Full encryption and activity traceability.
Flexible Pricing
$1 trial, $199 Standard, $299 Premium, SMB custom.
Competitive Landscape
Option
Limitations
Why ProVal Wins
Manual Processes
Weeks of work, high error rate
70% faster cycles via automation
Generic AI Tools
Not audit-defensible
Hybrid AI + rules, compliance-trained
Legacy Validation Software
Complex, costly, outdated UX
Simplicity, scalability, privacy-first
Lessons & Future Roadmap
What Worked
Combining pre-vetted templates with an AI assistant drove adoption.
Challenge
Ensuring domain-specific accuracy in GPT responses.
Improvement
Integrated RAG layer strengthened reliability.
Next Phase
- Expanded EU MDR and global compliance coverage.
- Integration with QMS/PLM systems.
- SMB-grade add-ons (SSO, SOC-2, API access).
- Launch of compliance analytics dashboards.
Conclusion
With Pendoah as its technology partner, ProVal AI became the first scalable, regulation-ready AI platform for validation and quality, delivering measurable time and cost reductions while enhancing trust in compliance workflows.