Cloudtheapp is an AI-powered, no-code electronic Quality Management System (eQMS) built for regulated industries including Life Sciences, Pharmaceuticals, Medical Devices, Biotechnology, Food & Beverage, and Manufacturing.
The platform is fully validated to FDA 21 CFR Part 820 (QMSR), 21 CFR Part 11, ISO 13485:2016, ISO 9001, and ISO 22001 — and ships a complete Computer System Validation (CSV) package with every platform update, so your team inherits a validated state without running IQ/OQ/PQ internally.
Cloudtheapp includes 45+ pre-configured quality and compliance applications available out of the box, covering the full scope of an enterprise quality system: CAPA, Document Control, Audits, Nonconforming Material, Deviations, Change Management, Design Controls, FMEA, Risk Assessments, Supplier Qualification, Training, Complaints, Out of Specification, HACCP, Batch Records, Calibration, EHS, and more.
What makes Cloudtheapp different is its AI-driven, no-code configurability. Using the platform's built-in natural language interface — Thunder AI — quality teams describe a process in plain English and the system builds a production-ready compliance application in minutes, without coding or IT involvement. Workflows, forms, approval hierarchies, and dashboards are all configurable without professional services.
The platform's configuration management architecture supports unlimited Dev, QA, and Production environments at no extra cost. Teams configure in Dev, validate in QA, and push to Production in a single click — in under three seconds. This makes change control and re-validation after updates fast, predictable, and auditable.
Cloudtheapp's 21 CFR Part 11-compliant electronic signature and tamper-evident audit trail capabilities are built into the core architecture — not add-on modules. Every record, approval, and action is captured automatically with a time-stamped, immutable audit trail that satisfies FDA inspection requirements.
The platform also supports external party collaboration at no additional cost. Supplier Corrective Action Requests (SCARs), supplier audits, and customer-facing quality workflows can be extended to external parties directly from the system, without requiring third-party licenses.
Built-in analytics provide real-time visibility across quality events, KPIs, CAPA cycle times, audit findings, and supplier performance — without exporting to spreadsheets.
Cloudtheapp is cloud-native, hosted on Amazon AWS, and operates on a SaaS model with seamless, validated, free platform updates pushed to all customers simultaneously.
Customers include quality, regulatory, and compliance teams at pharmaceutical manufacturers, medical device companies, biotech organizations, contract manufacturing organizations (CMOs), food and beverage producers, and industrial manufacturers who need a single validated system that scales from startup to enterprise without replacement.
Key differentiators:
- Pre-validated platform with full IQ/OQ/PQ package per update
- 45+ compliance applications — deploy only what you need
- AI-powered no-code configurability (Thunder AI)
- Unlimited configuration environments at no extra cost
- External party collaboration (suppliers, customers) at no extra cost
- 21 CFR Part 11-compliant at the core
- FDA 21 CFR Part 820 (QMSR), ISO 13485, ISO 9001, ISO 22001 compliant
- Built-in analytics and reporting
Book a free demo at cloudtheapp.com/demo/
Average Rating: 5.0/5.0
Total Reviews: 4
How Do G2 Users Rate Cloudtheapp eQMS?
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Has the product been a good partner in doing business?: 10.0/10 (Category avg: 9.2/10)
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Flexibility: 8.3/10 (Category avg: 8.7/10)
Who Is the Company Behind Cloudtheapp eQMS?
Who Uses This Product?
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Company Size: 50% Medium, 50% Small
