Everything you need to know before you decide.

Cloudtheapp is built for regulated industries: Life Sciences (pharma, biotech, medical devices, clinical research), Food & Beverage (FSMA, HACCP), Manufacturing, Aviation, and Environmental Health & Safety. The platform ships with pre-configured quality systems for each vertical, so a medical device company gets a system configured to 21 CFR Part 820 and ISO 13485 out of the box, while a food manufacturer gets one configured to FSMA 21 CFR Part 117 and HACCP.

The platform includes 60+ modules covering every major quality and compliance workflow, CAPA, Document Control, Audit Management, Change Management, Risk Assessment, Deviation Management, Complaint Handling, Supplier Qualification, Training, and more. You activate only the modules your team needs. There is no requirement to use the full catalog. Most customers start with 5 to 10 core modules and expand over time through the Cloudtheapp Store without any additional implementation work.

The confirmed AI capability in Cloudtheapp today is the application builder. You describe a workflow in plain English, including the form fields, approval chain, notification rules, and record logic your process requires, and the AI translates that description into a fully configured, deployable application. No coding, no developer, no configuration consultant required.

In practice, this means a quality manager can build and deploy a new application in minutes rather than weeks. A CAPA workflow that previously required a vendor ticket and a change order can be reconfigured by your own team the same day you identify the need.

The application builder is part of the platform's broader no-code design system, which includes a drag-and-drop form designer, a visual workflow builder, and a configuration management environment that lets you build in a development environment, validate in QA, and push to production in a single click.

Additional AI capabilities are in active development. They will be announced when they are available and fully validated.

Cloudtheapp is built on a no-code configuration model. Your quality team can modify forms, workflows, approval chains, notification rules, and reporting dashboards using a drag-and-drop designer, without writing a line of code and without involving IT. Changes made in the development environment can be cloned to production in a single click in under 3 seconds. This is a material difference from legacy QMS platforms where every configuration change requires a vendor ticket, a change order, and a revalidation cycle.

The three most significant differences in practice:

• Implementation time: Cloudtheapp customers go live in 6 weeks. Legacy platforms average 9 to 18 months.
• Total cost: Cloudtheapp is priced at less than one-third the total cost of ownership of a comparable legacy deployment when you include implementation, validation, licensing, and annual maintenance fees.
• Configuration speed: A Cloudtheapp quality team can reconfigure a workflow in minutes without IT involvement. A comparable change in a legacy system typically takes weeks and requires a vendor services engagement.

We have full side-by-side comparisons on the Comparisons pages.

Cloudtheapp is cloud-native, built from the ground up as a SaaS platform on Amazon Web Services (AWS). It is not a legacy on-premise system that was moved to a hosted environment. This distinction matters because cloud-native architecture means all customers receive the same validated update simultaneously, with no upgrade projects, no revalidation burden on your team, and no divergent versions across sites.

Yes. Cloudtheapp is validated to FDA Computer System Validation (CSV) guidelines. For every platform update, Cloudtheapp provides a complete validation package, including IQ/OQ/PQ protocols, test scripts, and all required documentation artifacts. Your team does not need to author or execute a full revalidation for every release. You review the provided package, execute the user acceptance testing (UAT) specific to your configuration, and sign off. This reduces your validation burden from months to days per release cycle.

Yes. The Cloudtheapp platform was updated and revalidated ahead of the QMSR effective date of February 2, 2026. All workflows, records, and audit trails are structured to meet the QMSR's requirements, including the updated design control, risk management, CAPA, and supplier control provisions. Customers who transitioned to Cloudtheapp before February 2026 were QMSR-compliant on day one of enforcement. If you are still on a QSR-era system, our resources library covers the gap assessment process.

Yes. Cloudtheapp is fully compliant with 21 CFR Part 11. This includes:

• Controlled access with role-based permissions
• Audit trails that are computer-generated, time-stamped, and operator-identified
• Electronic signatures with meaning statements (approved, reviewed, authored)
• Record retention and archiving controls
• System access controls and authority checks

All 21 CFR Part 11 controls are built into the platform at the infrastructure level, not bolted on as an add-on module.

The Cloudtheapp platform ships with a pre-configured ISO 13485:2016 quality system. Every module, Design Controls, CAPA, Audit Management, Supplier Qualification, Document Control, Risk Assessment, is structured to the specific clause requirements of ISO 13485. Customers pursuing initial certification or preparing for surveillance audits can use the platform's pre-built workflows as the foundation of their QMS, reducing setup time significantly. We also publish ISO 13485 readiness resources in our white papers.

The platform supports EU MDR compliance through two specific module sets. The Regulatory Dossiers & Submissions module manages technical documentation packages, Clinical Evaluation Reports, Performance Evaluation Reports, and the technical file structure required by Annex II and III. The Post Market Surveys and Complaint Handling modules cover the MDR's post-market surveillance requirements. All records maintain the audit trail and electronic signature controls required under EU MDR Article 10 and Annex IX.

Every Cloudtheapp platform release includes a complete validation package containing:

• Software Requirements Specification (SRS)
• Validation Plan and Validation Summary Report
• Installation Qualification (IQ) protocol and executed results
• Operational Qualification (OQ) protocol and executed results
• Performance Qualification (PQ) test scripts
• Traceability Matrix linking requirements to test cases
• Risk Assessment for the software system

Your team's responsibility is to execute the PQ testing for your specific configuration and complete the UAT sign-off. The IQ and OQ are pre-executed by Cloudtheapp.

The average Cloudtheapp implementation takes 6 weeks from contract signing to production go-live. The four phases are:

• Week 1-2: Configuration, Cloudtheapp implementation engineers configure your modules, workflows, and approval chains to your documented process requirements.
• Week 3-4: Validation, IQ/OQ execution (pre-performed by Cloudtheapp), customer PQ execution, and UAT sign-off by your quality team.
• Week 5: Training, role-based training for all user groups. Your quality team, approvers, and end users receive dedicated training sessions.
• Week 6: Go-live, production launch with go-live support. Your Cloudtheapp customer success engineer is available during the first two weeks in production.

This 6-week timeline compares to 9 to 18 months for a typical legacy QMS implementation.

The primary input your team needs to provide is your documented process requirements, how you want each workflow to work, who the approvers are, and what your specific SOPs require. Cloudtheapp's implementation team handles all technical configuration. The typical time commitment for your quality team is 8 to 12 hours per week during the 6-week period, mostly in review sessions, UAT execution, and training attendance. You do not need IT resources, developers, or a dedicated project manager on your side.

Yes. Cloudtheapp supports multi-site deployments with site-level configuration, different workflows, approval chains, and record templates per site, while maintaining a unified quality system and consolidated reporting across all sites. Multi-site customers also benefit from the platform's supplier portal, which allows external parties to access and submit records directly into your QMS without requiring a full user license.

Every Cloudtheapp customer has a named Customer Success Engineer assigned for the life of the relationship, not just during implementation. Your CSE handles configuration changes, module activations, revalidation support for new releases, and quarterly business reviews. New modules you activate after go-live are typically configured and validated within 1 to 2 weeks. There is no separate professional services engagement required for module expansions.

Cloudtheapp has a structured migration program for customers transitioning from legacy QMS platforms, paper systems, or spreadsheets. The process has three components:

• Data extraction: We provide migration templates to structure your existing records, documents, CAPA records, audit findings, supplier lists, for import into Cloudtheapp.
• Record import: Cloudtheapp's implementation team handles the bulk import and validation of migrated records.
• Parallel run period: Before decommissioning your old system, Cloudtheapp runs in parallel for a defined period so your team can verify record completeness without any quality system gap.

The migration is designed to complete within the 6-week implementation window. Our resources library covers migration readiness before you start.

Zero-downtime migration means your quality operations continue uninterrupted throughout the transition. New CAPAs, documents, and audit records are processed in Cloudtheapp from day one of go-live. Historical records from your legacy system are migrated in the background and made available in Cloudtheapp without interrupting active work. There is no freeze period, no processing backlog, and no gap in your audit trail. FDA investigators looking at records that span the transition date will see a continuous, unbroken record history.

Cloudtheapp supports migration of:

• Controlled documents (SOPs, work instructions, forms, policies)
• CAPA records and associated investigation documentation
• Supplier qualification records and approved supplier lists
• Audit records and finding logs
• Training records and competency matrices
• Calibration and maintenance records
• Deviation and nonconforming material records
• Risk assessment and FMEA documentation

The scope of migration is defined during the pre-implementation discovery session. Records that cannot be imported in structured format are archived as PDF attachments linked to the relevant Cloudtheapp record.

Yes. Cloudtheapp includes a built-in integration engine that supports bidirectional data exchange with ERP systems including SAP, Oracle, and Microsoft Dynamics. Common integration use cases include:

• Supplier master data sync from ERP to Cloudtheapp Supplier Qualification
• Material lot and batch record data exchange with ERP production modules
• Nonconformance records triggering holds in ERP inventory management
• Change management records linked to ERP engineering change orders

Integrations are configured using Cloudtheapp's no-code integration builder. API documentation is available upon request.

Yes. Cloudtheapp integrates with LIMS platforms for lab testing result exchange (OOS records, lab test results into CAPA) and with MES platforms for batch record data, equipment calibration status, and production deviation triggers. The integration approach uses REST APIs or file-based exchange depending on the capabilities of your LIMS/MES. Your implementation engineer will confirm the specific integration design during discovery.

Yes. Cloudtheapp includes a supplier portal at no additional cost. Suppliers can receive records, submit SCAR responses, upload qualification documentation, and complete supplier surveys through the portal without requiring a Cloudtheapp user license. All supplier portal submissions are logged in your audit trail with timestamps and electronic acknowledgment. This eliminates the email-chain supplier management that most quality teams currently rely on.

Cloudtheapp runs on Amazon Web Services (AWS). AWS manages all infrastructure, physical security, network security, and hardware maintenance. Cloudtheapp manages application security, data encryption, access controls, and platform updates. The platform uses AES-256 encryption at rest and TLS 1.2 or higher for all data in transit. Data is replicated across multiple AWS availability zones for redundancy.

Cloudtheapp uses a fully configurable role-based access control (RBAC) model. Permissions are defined at three levels: module-level (who can access which application), record-level (who can view, edit, approve, or archive a record), and field-level (which fields within a record are visible or editable per role). Access control configurations are themselves tracked in the audit trail, every permission change is recorded with the user who made it, the timestamp, and the previous state. This meets the FDA 21 CFR Part 11 authority check requirements.

Cloudtheapp provides a 99.5% uptime SLA for all production environments. Platform updates are deployed during scheduled maintenance windows communicated in advance. Because Cloudtheapp is cloud-native, updates are pushed to all customers simultaneously without requiring each customer to initiate or manage an upgrade. Maintenance windows are typically under 2 hours and scheduled during off-peak hours by region.

Yes. Cloudtheapp supports SAML 2.0-based Single Sign-On and integrates with enterprise identity providers including Okta, Microsoft Azure Active Directory, and Google Workspace. SSO allows your users to access Cloudtheapp using their existing corporate credentials, and it enables your IT team to manage user provisioning and deprovisioning through your existing identity management system.

Cloudtheapp is priced on an annual subscription basis. The subscription includes platform access, all modules your team activates, all platform updates and revalidation packages, the supplier portal, standard integrations, and customer success support. There are no per-module licensing fees, no per-update charges, and no separate validation consulting fees for standard releases. Pricing is based on the number of users and the scope of modules deployed. See our pricing page or contact us for a specific quote based on your organization size and requirements.

When you account for all cost components, licensing, implementation professional services, validation services, annual maintenance, upgrade projects, and IT support, Cloudtheapp's 3-year total cost of ownership is typically less than one-third of a comparable legacy deployment. The largest savings come from three sources:

• Implementation: 6 weeks vs. 9-18 months eliminates months of internal team time and vendor professional services fees.
• Upgrades: Legacy platforms charge significant professional services fees for each major version upgrade. Cloudtheapp updates are included in the subscription at no additional cost.
• Configuration changes: No-code configuration eliminates the vendor services engagement required for every workflow change in a legacy system.

Our resources library includes a detailed business case with cost comparison data.

Yes. Cloudtheapp offers a 30-day free trial with access to the full platform, not a limited demo environment. Your team can configure workflows, load test data, and evaluate the modules relevant to your quality system. Trials are provisioned with a dedicated development environment so you can test without affecting any production data. Start your trial or book a guided demo here.

All platform updates are included in the subscription at no additional cost. This includes both feature updates and the full validation package that accompanies each release. Cloudtheapp pushes updates to all customers simultaneously. There is no opt-in process, no upgrade project, and no divergent version risk. Your Customer Success Engineer will notify you ahead of any release and walk your team through new features relevant to your configuration.

Every Cloudtheapp subscription includes:

• Named Customer Success Engineer, a dedicated technical contact for configuration questions, module expansions, and revalidation support
• Technical support, ticket-based support for platform issues with SLA-defined response times
• Release support, advance notification and documentation for every platform release
• Training library, on-demand video training for all user roles
• Quarterly business reviews, structured review of your quality system performance and expansion opportunities

Enterprise customers have access to elevated support tiers with faster response SLAs and dedicated technical account management.

Training is delivered in three formats:

• Implementation training: Role-based live training during weeks 4-5 of implementation. Separate sessions for quality team admins, approvers, and end users.
• On-demand library: Video walkthroughs for every module, available in the platform for self-service training of new hires.
• Admin training: Dedicated training for your system administrators covering configuration, user management, and validation documentation.

Training materials are updated with each platform release. New hires can be trained to full operational proficiency in under 2 hours for their role-specific modules.

Cloudtheapp customers have access to inspection readiness support from their Customer Success Engineer. Before an announced inspection, your CSE can:

• Run a pre-inspection audit trail review across your key modules
• Confirm all electronic signature and 21 CFR Part 11 controls are current
• Generate the audit summary reports FDA investigators typically request
• Review CAPA effectiveness documentation for all closed CAPAs within the inspection scope

The platform generates all standard FDA documentation on demand, CAPA logs, change control logs, complaint summaries, audit histories, and training records, in FDA-standard formats.

Two paths:

• Book a demo: A 45-minute guided session with a Cloudtheapp quality engineer who will walk you through the modules relevant to your quality system. Book here.
• Start a free trial: Access the full platform for 30 days with a dedicated development environment. Same link.

If you want to build your business case before engaging sales, the Resources page has toolkits, regulatory guides, and evaluation checklists, all free, no sales call required.

When you create a new team on Cloudtheapp, you will be asked to select the subscription plan (Standard or Advanced) , and the number of users. On that date, your 30 day free trial for the platform begins. No credit card is needed to create the trial. 30 days later if you did not enter a credit card, the system will automatically cancel your subscription. However if you decide to proceed, you should adjust the number of users on the subscription plan and enter a credit card before the 30 days have elapsed. This can be done directly from the system, by clicking the (Subscriptions and Payments) link within your team.

Likewise a 30 day free trial is started for each paid app from the first time you download the app. At the end of the 30 days the first subscription payment will be charged to your card on record, unless you cancel the app subscription before the free trial ends. This is also managed from the subscriptions and payments screen of your team (App Subscriptions) tab.

All billing, financial transactions, credit card details etc… are handled through our billing processor: Stripe

Stripe is a worldwide leader in payments processing, and operates in over 45 countries, 135 currencies, and processes over $600B+ in payments per year.

We accept Visa, Mastercard, American Express, and Discover.

We also support manual invoices & Bank Transfers.

For more details on the cards and regions, please see: Stripe (Payments Processor) Supported Cards

All Cloudtheapp pricing, invoicing, and billing is in US Dollars. Cloudtheapp Pricing

Cloudtheapp uses Stripe platform for subscription and billing management. Stripe is trusted by millions of companies around the world, and provides PCI compliant services. As part of any checkout process, Cloudtheapp does not store credit card information on file, and credit card number get only stored in stripe in an encrypted manner.

Please refer to our subscription agreement. It is linked below, as well as at the footer of every page of our website as well as the Cloudtheapp platform new user signup page, and new team creation page. Cloudtheapp reserves the full right to make changes to its Subscription Agreement at any time.

Subscription Agreement

Cloudtheapp is a Configurable Cloud Platform built for the compliance world. Our vision is to provide you with the most configurable easy to use Quality Management and Regulatory Compliance SaaS software on the market.

Read more

Software licensed as a subscription paid for periodically (often monthly or yearly).

Typical features include:

• Central management
• Simplified and more frequent and reliable upgrades
• Reduced IT management costs and no need to invest in hardware
• Hosted on the cloud so accessible everywhere
• Instantly on (self service signup and subscription management)

Cloudtheapp is a US based company, started in the North East (NY), then expanded to Texas, and now operates out of Houston.

As a US company Cloudtheapp complies with all US laws, export restrictions and sanctions. US Department of Treasury Active Sanctions Programs

Additionally as all financial transactions (as well as financial data retention) are conducted through our billing processor Stripe, we follow their list of prohibited businesses: Prohibited and Restricted Businesses

New customers, can use our contact form, demo request form or email us: info (at) cloudtheappinc.com

For existing customers, all paid plans come with Cloudtheapp support including in-platform online help, and direct email contact for designated named callers (1 contact for Basic plan, and 3 for advanced). They can also email our general support email: support (at) cloudtheappinc.com

• Infrastructure Security: Cloudtheapp runs on top of many Amazon AWS managed services, and these services implement a very high standard when it comes to security. Just an example on that is that we deploy our front-end logic through Cloudfront, which provides Network and Application Layer protection against attacks.
• Application Security: We have thorough Application Security requirements documented as part of our Business Requirements Specification, and we have Automated Tests that cover these requirements in details. Security tests are documented as part of Validation Documentation for every platform update.

Our policy is linked below and also at the footer of every page of our website, as well as the signup form for new Cloudtheapp platform users. Cloudtheapp may change its Privacy Policy from time to time, and encourages visitors to frequently check this page for any changes.

Privacy Policy