Solutions Β· EQMS

Quality management that runs asone connected system.

Cloudtheapp EQMS brings CAPA, document control, audits, training, complaints, and change into a single pre-validated operating model, so quality teams stop stitching evidence together at audit time.

ISO 9001
ISO 13485
21 CFR Part 11
FDA QMSR / Part 820
Quality director reviewing a Cloudtheapp quality dashboard covering document status, CAPA effectiveness and compliance, above a strip of regulated-industry production scenes
1 platform

Quality events, documents, training, audits, and management review tied together.

0 recoding

Configurable workflows without waiting on developers or consulting-heavy rewrites.

Real-time

Dashboards surface overdue actions, repeat causes, and rising risk signals early.

60+
Applications, one validated platform
100% Configurable
Tailored to your business processes
21 CFR
Part 11 e-records and e-signatures
1
Connected, audit-ready system of record
Pressure points

What EQMS leaders are usually trying to fix

The operational pressures are specific, and so are the responses Cloudtheapp is built to give.

The pressure

Fragmented quality processes

CAPA, audit, and complaint processes live in separate tools, creating duplicate data and weak root-cause visibility.

Documents cut off from training

Document control sits apart from training, change control, and effectiveness verification, so a revision never reaches the people who need it.

Manual audit preparation

Audit prep still relies on spreadsheets, email searches, and heroic last-minute compilation the week before the auditor arrives.

Our response

One governance model

Unify quality issues, CAPA, deviations, documents, audits, training, and management review under a single operating model.

Risk-based approvals

Route approvals with e-signatures, due dates, escalation, and a complete audit history on every record.

Automatic downstream actions

Launch retraining and linked actions the moment a document changes, a finding is raised, or a complaint crosses threshold.

What buyers should feel quickly

Structured control, less manual stitching, and clearer operating visibility.

Multi-site audit readinessComplaint-to-CAPA traceabilityControlled SOP changes with auto-retrainingBoard-level quality KPI reviews
Core capabilities

What the solution is designed to do

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One governance model

Unify quality issues, CAPA, deviations, documents, audits, training, and management review under one operating model.
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Controlled approvals

Route risk-based approvals with e-signatures, due dates, escalation, and a complete audit history.
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Event-driven automation

Launch downstream actions automatically when a document changes, an audit finding is raised, or a complaint crosses threshold.
πŸ“Š

Live leadership view

Give leadership a live view of performance, backlog, repeat findings, and closure effectiveness.
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Advanced Analytics

Transform operational and quality data into meaningful insights with configurable dashboards, trend analysis, KPI tracking, and interactive reports that help teams identify risks, monitor performance, and support informed decision-making.
Workflow map

A practical Cloudtheapp EQMS control loop

From signal to documented outcome, without losing traceability.

Detect issue
Investigate root cause
Launch CAPA
Update documents & training
Verify effectiveness

Each stage can trigger approvals, linked actions, document updates, retraining, and management visibility inside one operating model, so every signal ends in a documented, traceable outcome.

Applications map

Relevant Cloudtheapp applications for EQMS

Each application ships with quality-aligned workflows, records, and approvals, so your team starts with a controlled foundation, not a blank page.

Unified Event Management

Quality Issues

Learn More

One intake for internal, customer, supplier, and operational quality signals, with triage, ownership, and links out to CAPA, audits, and change.

Capabilities
  • Structured intake with risk-based triage
  • Single event record across sources
  • Approvals with a full electronic audit trail
  • Automatic links to CAPA, complaints, and change
Compliance Coverage
ISO 9001ISO 1348521 CFR Part 11
Why it matters

The core system record every quality signal starts from.

Explore all Applications

Explore the complete Applications Hub to discover 60+ prebuilt applications for Quality, Safety, Compliance, Manufacturing, Clinical, Laboratory, and Business Operations.

Standards and regulations

Built for the obligations that define this buying decision

Mapped into workflows, approvals, and day-to-day evidence, not static policy text.

ISO 9001

Quality management system requirements mapped into controlled workflows and evidence.

ISO 13485

Medical-device QMS expectations across documents, CAPA, and design-adjacent controls.

21 CFR Part 11

Electronic records and signatures with audit trail and controlled access.

FDA QMSR / Part 820

Quality System Regulation obligations expressed as day-to-day workflows.

ISO 19011

Auditing guidance built into the audit program and findings model.

GxP-ready workflows

Controlled, validation-minded operations suitable for regulated environments.

How we compare

Why this lands harder than a generic regulated-software page

Feature✦ CloudtheappTypical alternative
Quality events, CAPA, documents, audits, and training connectedβœ“βœ—
Risk-based approvals with e-signatures and audit trailβœ“βœ—
21 CFR Part 11 records and signatures built inβœ“βœ—
Change auto-triggers document updates and retrainingβœ“βœ—
Configurable without custom developmentβœ“βœ—
Audit evidence generated by daily workβœ“βœ—
One platform across quality, lab, and supplierβœ“βœ—
Customer stories

Trusted by quality teams that needed speed without losing control.

Fast-Track Implementation

Your solution. Configured and live in as little as 30 days.

Start with the applications your team needs most, configured for your processes and ready for production in a few weeks.

  • Start with a clear scope

    Select the initial applications, workflows, and priorities your team needs first.

  • Configured for your processes

    We configure the selected applications around the way your organization works.

  • Guided through go-live

    Clear milestones, team reviews, training, and a structured path to production.

Frequently asked questions

Questions buyers are likely to ask

Yes. Teams can deploy a focused stack such as Documents plus CAPA first, then add audits, complaints, training, and management review as maturity increases.

Yes. The same platform supports ISO 13485, FDA QMSR, food safety, supplier quality, and other highly controlled environments.

Evidence is generated by day-to-day execution: approvals, timestamps, linked records, findings, actions, and dashboards are already in the system.

A focused first release can start with the highest-priority workflows, then expand into adjacent applications without rebuilding the operating model.

Ownership usually spans quality plus the teams closest to the work, with shared visibility across operations, regulatory, and leadership.

Yes. Routing, fields, approvals, and dashboards are configurable, so the system evolves without starting over.

Book a demo

Turn EQMS interest into a real buying conversation.

Book a walkthrough, explore the application set, or keep scanning adjacent solution pages in the same family.

πŸ”’ 21 CFR Part 11βœ… ISO 13485🏭 ISO 9001☁️ AWS Hosted