ProVal AI
ProVal AI
ProVal AI is the first AI Thought Partner for Validation & Quality. It helps regulated industries like medtech, pharma, and biotech cut compliance costs, speed up documentation, and pass audits with confidence.
With Pesdoe as the technology partner, ProVal AI achieved:
Market Context
The global market for compliance and quality management software is projected to exceed an impressive $20 billion by the year 2030. This growth is particularly significant for small to medium-sized medical technology companies, where the annual costs associated with compliance can range from $250,000 to $500,000. These figures highlight the financial burden that these companies face as they strive to meet regulatory standards and ensure the safety and efficacy of their products.
Moreover, it’s crucial to recognize that a staggering 45% of failures during FDA audits stem from inadequate documentation. This statistic underscores the importance of having robust compliance systems in place. Companies that invest in comprehensive quality management software not only mitigate the risk of costly audit failures but also enhance their operational efficiency and product quality, ultimately leading to better patient outcomes.
This is a massive, underserved market where precision and trust matter as much as speed.
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 Enterprises
We focus on AI solutions for enterprise 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.
Before ProVal AI
- Weeks to generate validation documents
- Dependence on costly consultants.
- High error rates and audit stress.
User Personas
QA Leader
Wants speed + audit confidence
Startup Founder
Needs compliance without hiring large QA teams.
Consultant
Wants to scale client work without losing quality
Enterprise Team
Needs traceability across large, complex systems.
Features & Modules
Implementation Journey
01
Business Objective Mapping
Identify how AI for business strategy connects to your specific goals, whether it’s increasing revenue, improving operational efficiency, or enhancing customer experience.
02
Business Objective Mapping
Identify how AI for business strategy connects to your specific goals, whether it’s increasing revenue, improving operational efficiency, or enhancing customer experience.
03
Business Objective Mapping
Identify how AI for business strategy connects to your specific goals, whether it’s increasing revenue, improving operational efficiency, or enhancing customer experience.
04
Business Objective Mapping
Identify how AI for business strategy connects to your specific goals, whether it’s increasing revenue, improving operational efficiency, or enhancing customer experience.
05
Business Objective Mapping
Identify how AI for business strategy connects to your specific goals, whether it’s increasing revenue, improving operational efficiency, or enhancing customer experience.
Design Principles
Privacy-first
Zero-training policy.
Audit-defensible
AI + rules logic.
Simplicity
Snack-sized workflows, not heavy dashboards.
Scalable
Equally effective for startups and global firms.
Human-in-the-loop
Templates vetted by experts.
Features & Modules
Validation Document Generator
Plans, risk files, reports.
Risk Assessment Engine
Hazard analysis, scoring, test traceability.
Consulting Chatflow
Compliance questions answered interactively
Template Library
Editable, human-approved docs.
Audit Logs & Security Layer
Encryption, access control, traceability.
Flexible Pricing
$1 trial, $199 Standard, $299 Premium, Enterprise custom.
Competitive Landscape
Option
Limitations
Why ProVal Wins
Manual processes
Weeks of work, high error rate
AI accelerates by 70%
Generic AI tools
Not audit-defensible
Hybrid AI + rules, compliance-trained
Legacy validation software
Complex, expensive
Simple, scalable, privacy-first
Results
Quantitative
Quantitative
Designed for Enterprises
We focus on AI solutions for enterprise 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.
The Vision
AI alone isn’t enough
Rules + human oversight are critical.
Trust drives adoption
Security and privacy-first design mattered most
Simplicity wins
Guided, snack-sized workflows ensured usability
Future Roadmap
- Add EU MDR and global regulatory coverage.
- Integrate with QMS/PLM systems.
- Launch compliance analytics dashboards.
- Enterprise-grade add-ons: SSO, SOC2, APIs.
Conclusion
With Pesdoe as its technology partner, ProVal AI became the first scalable, regulation-ready AI platform for validation and quality. It cuts time, reduces costs, and builds trust in industries where failure isn’t an option.