✦AI-Powered · Pre-Validated · FDA 21 CFR Part 11

Quality that adapts to you.
Not the other way around.

The world's most configurable cloud QMS for regulated industries, implement in days, build compliant applications in minutes with AI, and benefit from a pre-validated platform for FDA, ISO 13485, and QMSR, with zero revalidation effort on every update.

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β˜…4.8/5Capterra
🏭25+Industries
⚑Deploy in30 days
πŸ”’100%Pre-Validated
The Cloudtheapp QMS on a monitor and a phone on a production floor β€” batch records, complaints, CAPA and document apps beside a quality dashboard β€” above the industries it serves: pharmaceutical, electronics, food and automotive manufacturing.The Cloudtheapp QMS on a monitor and a phone on a production floor β€” batch records, complaints, CAPA and document apps beside a quality dashboard β€” above the industries it serves: pharmaceutical, electronics, food and automotive manufacturing.
60+
Quality Applications
100%
Pre-Validated Platform
3sec
Config to Production
$0
Revalidation Cost

Trusted by quality-driven organizations worldwide

Niagen Bioscience
Crosby's
Gentherm
Solas Healthcare
Kaffe Bueno
Kosma Kare
Conavi Medical
MIP
Ansen Corporation
Sonic Incytes
QBiotics Group
Neuro Spinal Innovation
ASEA Power Systems
InkSpace Imaging
Big Fish
Xantrex
TWI
NutraSky
Mukava Biosignals
The Problem We Solve

Paper QMS is costing you more than you realize

Most regulated organizations still manage critical quality data in spreadsheets, binders, and email threads.

❌ Without Cloudtheapp

The Paper Reality

Where most regulated organizations still operate today

  • πŸ“‹ Three versions of the same SOP in circulation at once
  • πŸ“Š CAPAs in Excel, tracked only when auditors arrive
  • ⚠️ Training compliance always 2 weeks behind actual status
  • πŸ” 3-hour record scramble before every FDA inspection
  • πŸ’Έ COPQ running at 10–15% of annual revenue undetected
  • 🚨 FDA 483 observations from version control failures
  • βœ‰οΈ Supplier quality managed entirely through email chains
βœ“ With Cloudtheapp

The Digital Standard

Stage 4 QMS maturity, in practice

  • βœ… One controlled version live on every device instantly
  • βœ… CAPAs auto-routed, escalated, and tracked to effectiveness closure
  • βœ… Training compliance real-time, auto-retraining on doc revision
  • βœ… Any audit record retrieved in seconds with tamper-evident trail
  • βœ… COPQ dashboards surface issues before failures occur
  • βœ… 21 CFR Part 11 compliance built into every workflow by design
  • βœ… Supplier SCARs, qualification, and audits in one unified platform
60+ Applications

Everything quality, safety & compliance. One platform.

CAPA
Document Control
Deviations
Audit Management
Training & Learning
Risk Assessments
Supplier Qualification
Change Management
Complaints
Design Controls
FMEA
Management Review
Incidents & EHS
Permit to Work
Batch Records
Chemical Management
Calibration
Equipment
Nonconforming Material
HACCP
ERM
Lab Testing
Validation
Objectives & Targets
Why Cloudtheapp

The features your QMS team has always wanted

AI-Powered Configurability, No Code. No IT. No Waiting.

Describe your quality process in plain English. Cloudtheapp's AI builds the application, workflow, form, and dashboard in minutes. Adapt any of the 60+ apps without writing a single line of code. When your processes change tomorrow, your QMS updates today.
⚑ Industry First

Pre-Validated on Every Update

Every platform update ships with a complete IQ/OQ/PQ validation package. Zero revalidation cost. Zero IT involvement. Stay current without compliance disruption.
βœ“ FDA Validated

Deploy in Days, Not Months

Download any app from the Cloudtheapp Store in one click. Move from Dev to QA to Production in under 3 seconds. Fastest time-to-value in the market.

External Party Connectivity, Free

Send SCARs, share quality records, and collaborate with suppliers and auditors directly inside the platform at no extra cost. Full traceability on every exchange.

Built-In Real-Time Analytics

CAPA aging, deviation trends, training compliance, supplier scorecards, live dashboards built in. No BI tool required. No manual reporting. Just the answers you need.

Unlimited Environments at No Extra Cost

Create unlimited Dev, QA, and Production stages. Clone configurations in one click. Validate in QA, deploy to Production in 3 seconds. Best-in-class configuration management.
Live Platform

Real-time quality visibility across your entire program

Know your CAPA status, training compliance, deviation trends, and audit readiness, without asking anyone for a report.

  • βœ“Executive quality dashboards updated in real time
  • βœ“Cross-module connections, CAPA auto-triggers training assignments
  • βœ“Tamper-evident audit trail on every record by design
  • βœ“Role-based access with e-signature at every workflow step
  • βœ“Multi-site, multi-language, fully responsive on any device
See the Full Platform
Quality Performance Overview
Updated live Β· ISO 13485 Β· 21 CFR Part 820
12
Open CAPAs
↓ 20% vs. last month
98%
Training Compliance
↑ On track
CAPA On-Time Closure
87%
Audit Finding Closure
92%
Document Control
99%
Supplier Qualification
76%
βœ…Audit-Ready AlwaysπŸ€–AI-Configured
Solutions

Configurable solutions for every regulated operation.

Bring quality, safety, compliance, laboratory, clinical, regulatory, manufacturing, and customer processes together on one connected platform.

60+ applications. One configurable platform.

  • Quality, Safety & Supplier ManagementEQMS, Food Safety, Supplier Quality, and EHS solutions configured around your processes.
  • Clinical, Regulatory & Laboratory OperationsManage clinical trials, regulatory information, laboratory operations, and system validation.
  • Manufacturing, Risk & Customer OperationsConnect manufacturing execution, enterprise risk, logistics, and customer service processes.
Platform Comparison

Why teams choose Cloudtheapp over legacy QMS

Feature✦ CloudtheappLegacy QMSPaper / Excel
Pre-Validated on every updateβœ“βœ—βœ—
AI No-Code Configurationβœ“βœ—βœ—
Deploy in Days (not months)βœ“βœ—N/A
60+ Integrated Applicationsβœ“Partialβœ—
Built-In Real-Time Analyticsβœ“Limitedβœ—
External Party Connectivity (free)βœ“βœ—βœ—
Unlimited Dev/QA/Prod Environmentsβœ“βœ—N/A
Free Seamless Upgradesβœ“PaidN/A
21 CFR Part 11 Complianceβœ“Partialβœ—
Full Audit Trail on Every Recordβœ“Partialβœ—
Compare All QMS Solutions→

See how Cloudtheapp compares with other QMS solutions in the market.

Customer Stories

What quality leaders say about Cloudtheapp

Get Started

Ready to run quality the way it was always meant to be run?

Book a personalized demo. See the full platform. Deploy your first app the same day. No long contracts. No revalidation projects. Just quality, done right.

πŸ”’ 21 CFR Part 11βœ… ISO 13485🏭 ISO 9001⭐ 4.8/5 Capterra☁️ AWS Hosted