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Company description

Cloudtheapp is an AI-powered, cloud-native Quality Management and Compliance platform built on a validated infrastructure that adheres to FDA regulations and Computer System Validation Guidelines. Designed for life-changing industries including pharmaceuticals, medical devices, biotech, food and beverage, healthcare, and manufacturing, Cloudtheapp delivers configurable, no-code solutions that enable organizations to streamline compliance processes, optimize workflows, and accelerate digital transformation initiatives.

Built by industry veterans with over three decades of experience, Cloudtheapp operates as a fully SaaS-based platform hosted on Amazon AWS. It supports compliance with FDA 21 CFR Part 820 (QMSR), 21 CFR Part 11, Life Sciences cGMP, ISO 13485, ISO 9001, and ISO 22001 standards. The platform provides a comprehensive validation package with every update, including all necessary documentation and artifacts to support Good Documentation Practices (GDP) and regulatory compliance.

Core Platform Capabilities

• AI-Powered Configurability: Cloudtheapp's advanced AI technology, including the Cloudtheapp Thunder feature and a drag-and-drop designer, allows users to build and customize sophisticated applications in minutes using natural language input — eliminating the need for coding.
• Isolated Cloud Architecture: Built cloud-native from inception on Amazon AWS, the platform delivers unlimited scalability, dependability, and optimum performance.
• Life Sciences-Specific Features: The platform includes field history (audit trail), transaction history tracking, electronic signatures (e-sig), forced authentication on record routing or saving, and other features required by life sciences organizations.
• PaaS / SaaS Model: Cloudtheapp is 100% SaaS with multitenant architecture. Systems are live seconds after signup, require only a browser and internet access, and include frequent updates at no additional cost. Subscription-based pricing with credit card payment simplifies procurement.
• Application Store: An integrated Application Store offers a wide range of free and paid applications — including a full EQMS suite — deployable with a single click. Applications can be used as-is, fully customized, or uploaded back to the store for other organizations to use.
• Stages: Users can create unlimited isolated environments (e.g., dev, QA, prod) within seconds, enabling safe design, testing, and production workflows. Transferring applications between stages takes approximately five seconds.

Solution Suite

• Enterprise Quality Management System (EQMS): Compliant with ISO 9001 and ISO 13485, the EQMS enables collaboration with suppliers, auditors, consumers, and other external parties directly within the platform — without requiring separate systems or email-based communication.
• Food Safety Management System (FSMS): Tailored compliance and quality management for food and beverage organizations.
• Supplier Quality Management (SQM): Facilitates seamless supplier collaboration and quality oversight.
• Environmental Health and Safety (EHS): Manages safety and environmental compliance processes.
• Regulatory Information Management (RIM): Supports regulatory submission and information tracking workflows.
• Enterprise Risk Management (ERM): Provides tools for identifying, assessing, and mitigating organizational risk.
• Laboratory Management System (LMS): Manages laboratory operations and data.
• Manufacturing Execution System (MES): Supports manufacturing process management and execution.
• Product Lifecycle Management (PLM): Oversees product development and lifecycle processes.
• Clinical Trials Management Solution: An advanced, AI-driven platform engineered to transform how life sciences organizations manage clinical trials.
• Operational Checklists Application: A dedicated application supporting operational excellence and compliance checklists.
• Data Analytics: Integrated analytics capabilities to support data-driven decision-making across quality and compliance functions.

Deployment, Compliance, and Integration

• Validated according to FDA Computer System Validation Guidelines and Good Documentation Practices (GDP), with a full validation package provided for every platform update.
• Compliant with FDA 21 CFR Part 820 (QMSR), 21 CFR Part 11, ISO 13485, ISO 9001, ISO 22001, and Life Sciences cGMP standards.
• Hosted on Amazon AWS with isolated cloud architecture ensuring security, scalability, and reliability.
• Multitenant SaaS architecture simplifies collaboration with external parties such as suppliers and auditors without exposing internal network infrastructure.
• No-code drag-and-drop designer tools allow organizations to build and integrate applications across all business processes without writing a single line of code.
• Supports internal and external collaboration, improving communication, feedback loops, and integrated quality and compliance management.
• Serves industries including pharmaceuticals, medical devices, biotech, food and beverage, healthcare, and general manufacturing.

Cloudtheapp empowers organizations to confidently navigate complex regulatory environments while driving efficiency, agility, and growth. With a 30-day trial and demo options available, companies can quickly experience how the platform transforms quality and compliance operations.

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Software attributed to Cloudtheapp

• EQMSView
• CTMSView
• LIMSView
• EHSView
• RIMView
• ERMView
• MESView
• Swift ValidationView
• Logistics and Customer Services SolutionView

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