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.

Watch a short EQMS Highllights Video

A central application to host all your documents and through their different phases with revision control. Use this application to control all your documents including policies, procedures, work instructions and much more. Seamless revision control and approval system to help you with getting your document approved as well as helping with revising approved documents. With built-in integration with our Learning system, tracking employees learning records is made simple and intuitive.

Here are some of major feature of our complete Document Management System:
- Ability to draft documents using different formats including Microsoft Word
- Predefined and configurable templates for different document types (Policies, Procedures, Work Instructions, etc.)
- Automatic synchronization of document fields (meta data) to the header and body of the document
- Ability to setup self-learning course for documents to distribute learning tasks and monitor progress
- Automatic PDF conversion upon releasing the document
- Ability to revise released documents with traceable version numbers.
- Automatic archiving for older revision upon releasing newer revision of the document
- Fully compliant electronic signatures, that can be automatically synchronized to the body of the attached document.
- Fully compliant audit trail.
- Ability to reference related documents.
- Fully configurable workflows and forms using leading edge No-Code designers.
- Built-in and integrated real time analytics that allows creating visualizations and dashboards
- Cloud based and SaaS (Fully managed and there is no need for IT infrastructure).

Whether you are dealing with adverse events or trying to prevent them, our Corrective & Preventive actions module is a critical part of your Enteprise Quality Management System. Use this app to handle quality issues you encounter. The process is designed to do root cause analysis to identify the exact cause of the issue, you can then document your action plan and execute it, before you end up with the final verification and effectiveness checks. If the issue is caused by an external party (like a Supplier) then you can send the record to the connected external party to provide issue resolution details for your approval and check. The connection with external parties was never an easy task, our CAPA system has made it not only possible but a very simple task.

Auditing may be a complicated task but using an audits module should not be. The most advanced and simplest audits module on the market is offered by Cloudtheapp. In this app, you can plan and execute your audits. If you are about to perform an internal or supplier audits, then this app is a perfect fit for your needs. You can use the app to document results of external party audits when you get audited. Start with defining checklist templates with common questions, then inherit these checklists in the audit record to start the auditing journey. Assign CAPAs and Recommendations and once you are done with the audit, the summary will be shown immediately so that you can communicate it in a seamless manner during the audit closing meeting.

An app that can be used to track all quality issues and events, including Internal, Supplier and Customer issues. In this app, you can document the containment of the issue and then do the proper analysis to decide about whether further actions are needed or not (like creating a Corrective Action or a Nonconforming Material).

Start with recording nonconforming material cases, and then take it through proper analysis to decide what to do with the nonconforming material. Then take that to the next level by creating a linked CAPA to do proper root cause analysis.

Learning is an essential part of any business in today’s world, use this system to load your course templates and delight your employees with the learning they need by loading Instructor Led or Self Learning courses. Track completion of learning tasks for employees in an easy way to ensure learning effectiveness as well as compliance with standards and regulations.

Use this system to document information about your suppliers as well as the materials they supply. The information from your Suppliers system will be available across the other modules where you can look up information in a seamless way in the other compliance modules like Corrective and Preventive Actions.

Use this system to document information about your Customers, as well as your products, and which products are sold to which customer. Additionally you can track customer contacts within each company. Looking up this information in other apps is very simple and intuitive. This also allows you to easily reference and link the customers in things like Audits or CAPAs.

Document your main production processes in this system. Track each process from design, to approval, and up to implementation. Easily link related products from the (Customers & Products) module as well as related documents from (Document Control). You can then reference them in the other compliance modules we offer.

A centralized application for all compliance tasks. Whether it is a task initiated from a Corrective Action Process or from a Nonconforming application process, this is the go-to app to find all of the tasks that were ever sent or assigned to you.

An application that can be used to implement change using a risk based approach. Different types of change records can be recorded including Process Change, Supplier Change, Product Change, and more.

An application that can be used to record and approve deviations from the standard process and/or procedure. Changes may be created directly or launched from a related Quality Issue. In case a deviation is permanent, a change record may be initiated. 

An application that can be used to identify, analyze, and calculate Risk based on Priority and Severity. It can also be used to document impact. A risk assessment record can be created directly or from a quality issue, where a related CAPA and/or Change Control record may be launched to mitigate identified issues.

An application that can be used to register risks within an organization:
- Identify risks and categorize them.
- Assess risks based on priority and severity and document impact and risk analysis.
- Create a response plan with an action to mitigate, transfer, avoid, remove, accept, or retain risks.
- Reassess risks after executing a response plan - Monitor risks closely.

An application that can be used to record and track equipment information. The application is integrated with the Calibration and Maintenance Module allowing the creation of Calibration and Maintenance records for each equipment based on a specified frequency.

An application that can be used to track equipment calibration and maintenance. The application is integrated with Equipment application to allow creating calibration or maintenance records using equipment profile. Calibration measurements or maintenance instructions and results can be populated from profiles and then filled by the person performing the procedure. Final calibration results can be tracked (As Found and As Left), and the same for maintenance end result. Records of the following types can be tracked: - Measurements Template - Instructions Template - Calibration - Maintenance

This Application can be used to reference and document all Requirements that an organization need to comply with.

These requirements could be coming from:
1. Standards: An example of that is the different clauses within the ISO 9001:2015 standard for Quality Management.
2. Regulations: An example of that is the relevant titles of the HIPAA Regulation.
3. Guidelines: An example of that are items within one of the guideline documents that the FDA issue to help industries.

“Compliance Reference” records can be created within the Application to reference standards, regulations, and guidelines; then within that record Requirement Records can be created as child records. The Application allows full revision control functionality to allow editing active requirements.

Compliance requirements can be referenced in other Modules, for example you can reference a specific requirement like an ISO Standard Clause in a Quality Issue or in an Audit Checklist.

An App that can be used for the various types of inspections. It can be used to inspect Materials, Products, Processes and much more.

You can initiate and approve different inspection templates, and then use them to launch inspections, which will inherit all inspection items along with the relevant photos for an easy inspection process.

The inspector can go through the different items marking them as Pass, Fail or N/A and document failure description for each item.

A Final result (Pass/Fail) for the whole inspection will be calculated automatically for you.

Batch Records is an App that can be used to track and manage product batches, including tracing all information about these batches like Lot Numbers, Quantities, Manufacturing and Expiration Dates and other information. The App can be referenced in other deployed applications to reference specific affected Batch/Lot numbers.

Use this App to record and investigate customer complaints. Start with recording information about the complaint and complainant, reference related product, then it should be possible to:
- Assess the risk and impact of the complaint (risk based approach).
- Decide about whether a Regulatory Reporting is required (eMDR, FAR, etc..).
- Carry out the investigation and record results.
- Define the action plan and corrective actions and take it through approval.
- Address the complaint by implementing action plan and defined CAPAs.
- Notify complainant before taking the complaint through closure.

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