RISK Management

Cloudtheapp offers a complete, and fully integrated QMS risk management solution to help you document, analyze, mitigate, and manage risks related to your business as needed. This will allow easy reference to information as well as launching tasks to act on the analysis. It also simplifies related audits and compliance with risk assessment guidelines and industry standards.

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 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.

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).

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 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.

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.

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.


Cloudtheapp's Enterprise Risk Management Application and how it integrates with other compliance processes for end-to-end handling.
On deploying the risk assessments module, configure probability and severity levels as needed. Then for each risk being assessed the system will automatically calculate the related risk. The user will then be able to perform the impact and risk analysis and attach any related documents or images as evidence.

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