Digital
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Enterprise
Quality Management System
ISO 9001 | ISO 13485
Our EQMS was built by a team of experts that possess over three decades of industry experience. The main goal was to come up with an Enterprise QMS and Compliance Solutions that remedy all pitfalls of other competing systems. We made collaborating with suppliers, auditors, consumers, or any other external party possible and instant, unlike other systems where you have to have additional disintegrated systems installed or use tedious back and forth emails. Our EQMS builders allow you extend usage of the ready-made applications to build and automate all of your other processes and have them all integrate with each other in hours and without having to write a single line of code.
Whether you are in Life sciences, Biotechnology, Medical Device, Pharma, or Manufacturing and whether you are looking to comply with a standard such as ISO 9001, ISO 13485, ISO 22001 or a regulatory body or government such as the FDA 21CFR part 820 or cGMP, our EQMS is set to allow you to comply and excel. Create three environment stages (Dev. QA. And Prod) or more (as many as your process may require) and then promote configurations across all stages with a click of a button in less than 5 seconds. Cloudtheapp is the only solution on the market that allows configurations to be transferred across environment stages with a click of a button and without any additional infrastructure or cost to you.
EQMS Applications
Advanced Inspections
The Advanced Inspections module is a powerful tool designed to streamline and enhance your organization’s quality control processes. Whether you
Adverse Events
Welcome to Cloudtheapp Adverse Events, where compliance meets efficiency in adverse event management. Our platform is meticulously designed to streamline
Batch Records
Batch production is an approach to manufacturing where the products are made as specified groups or amounts, within a certain
Bill of Materials
Welcome to Bill of Materials module, the ultimate solution for managing and optimizing your Bill of Materials. Our powerful app
Calibration and Maintenance
Calibration and maintenance are essential aspects of any Quality Management System, ensuring the quality and consistency of the products you
Change Management
Addressing Change to the Quality Management System and its processes is a key focus area in all Quality Management Standards
Complaints
Complaint is any report of dissatisfaction (written, oral or electronic) related to the quality, safety, or effectiveness of any manufactured
Compliance Requirements
Compliance means conforming to a rule, such as a specification, policy, standard or law. It is important for organizations to
Corrective and Preventive Actions
Corrective & Preventive actions module is a critical part of your Enterprise Quality Management System. Whether you are dealing with
Customers and Products
Customers are organizations that your entity provide with products and services. It is important to track customers within your implementation
Design Controls
The Design Controls module has been designed to ensure compliance with various regulatory requirements and standards, including ISO 13485, FDA
Deviations
As part of managing quality, there could be differences between observed values and expected values for a process or product
Failure Mode and Effects Analysis
The FMEA module is a powerful tool designed to empower organizations across various industries with a systematic approach to risk
Inspections
Inspection is an essential part of quality control in manufacturing. Characteristics of a product, material, or process are examined, and
Lab Testing
Quality Control Laboratory Testing serves an important function in Pharmaceutical, Biotechnology, Food Production, and many other industries. Whether used to
Management Review
Management review is the process of periodically reviewing the Quality Management System by top management to ensure its suitability, adequacy,
Nonconforming Material
In the complex realm of Quality, Safety and Compliance Management Systems, where precision and compliance are paramount, the management of
Out of Specification
Whether you are testing samples of product-released batches or materials/ingredients, there could be cases where the test result is not
Post Market Surveys
In the dynamic realm of medical device quality assurance, Cloudtheapp Surveys emerges as an indispensable tool, meticulously crafted to meet
Quality Issues
Use this module to track all Quality Issues and Events regardless of their source. Track internal, customer and supplier issues
Risk Assessments
Risk based thinking is crucial for everyday business decisions. It ensures being proactive instead of reactive when decisions are made.
Suppliers and Materials
Suppliers are entities that provide their products or services to your entity. Supplier Quality Management is an essential part of
Recent Posted Blog
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Join Australia’s first Pharmaceutical Development Conference (PDC), hosted by Aphex Pharma Solutions, on October 22nd, 2024 at Macquarie Park, Sydney. This unique event will bring
Empowering Healthcare: Cloudtheapp Adverse Events Redefines Compliance
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Revolutionizing Post-Market Surveillance: Introducing AI-Powered Post Market Surveys Application by Cloudtheapp
In our relentless commitment to revolutionizing quality management and regulatory compliance in the medical device industry, Cloudtheapp Inc. proudly unveils the innovative Post Market Surveys