Enterprise
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.
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ERM MODULES
Enterprise Risk Management
Roll out a business strategy that aims to identify, assess, and prepare for any dangers, hazards, and other potentials for disasters that may impact your organization’s operations and goals.
Similarly, identify opportunities and assess them, and maximize benefits by putting plans to address positive risks.
Introduce plans of actions, and make them accessible to all stakeholders. Ensure all risks and opportunities are under control while running the business successfully exceeding customers and stakeholders’ expectations.
key features
- Define strategic objectives and business plans.
- Identify various risks and opportunities, and map them to objectives.
- Classify risks and opportunities for better management:
  o Operational
  o Financial
  o Strategic
  o Compliance
  o Hazard - Perform risk assessment using quantitative and qualitative approaches.
- Assess probability, severity and impact. Automatically calculate risk level using risk assessment two dimensional matrix or three dimensional cube.
- Setup and define risk responses of different types:
  o Mitigate
  o Avoid
  o Accept
  o Enhance
  o Remove - Define plan of actions for each risk response, defining what needs to be done immediately, and what needs to be done based on a risk trigger. Have the different actions assigned to the team to ensure parallel processing with full collaboration.
- Setup controls with drills and tests to ensure your risks and opportunities are controlled by a solid process in place.
- Reassess your risks to ensure they are mitigated to acceptable levels.
- Ensure all risks are in a controlled state and run. Iteratively identify new risks based on changing business climate and address them.
- Fully compliant electronic signatures to capture approvals.
- Compliant audit trail to track changes up to the field level, with traceability on files.
- Configurable workflows and forms using leading edge No-Code designers.
- Built-in and integrated real time analytics solution that allows creating visualizations and dashboards.
- Cloud based and SaaS (Fully managed), which eliminates the need to deploy internal IT infrastructure, reduces your cost, and saves your time and effort.
- Implementation and data migration services to transfer your data from paper-based or other electronic systems.
Risk Assessments
Risk based thinking is crucial for everyday business decisions. It ensures being proactive instead of reactive when decisions are made.
Risk based approach must be followed in managing quality to ensure effectiveness of your Quality Management System. It ensures negative risks as well as positive opportunities are addressed.
Use this module to launch risk assessment from any process, and rely on the system to calculate the risk level for you based on predefined configurable matrices.
key features
- Launch risk assessment records from other processes like Quality Issues, CAPAs, Nonconforming Materials, Change Management and others.
- Calculate risk in a quantitative way and based on a predefined and configurable risk matrix.
- Fill risk dimensions like Probability (likelihood) and Severity, and let the system calculate risk level for you.
- Document qualitative information about the risk like risk assessment and impact assessment description.
- Attach files and photos to clarify risk and impact.
- Design and configure 2-dimensional risk templates (e.g., based on Probability and Severity).
- Design and configure 3-dimensional risk templates (e.g., based on Probability, Severity and Consequence)
- Make the right decision by following risk-based approach in Quality Processes. Your risk assessment is fully integrated in processes with full visibility on calculated risk level.
- Fully compliant electronic signatures to capture approvals.
- Compliant audit trail to track changes up to the field level, with traceability on files.
- Configurable workflows and forms using leading edge No-Code designers.
- Built-in and integrated real time analytics solution that allows creating visualizations and dashboards.
- Cloud based and SaaS (Fully managed), which eliminates the need to deploy internal IT infrastructure, reduces your cost, and saves your time and effort.
- Implementation and data migration services to transfer your data from paper-based or other electronic systems.
documents
A centralized module to host all your documents and through their different phases with revision control. Use this module to control different types of documents including policies, procedures, work instructions and much more.
Seamless revision control and approval systems to help you with releasing your documents. Tracking employees learning records is made simple and intuitive with learning system integration.
key features
- Ability to draft documents using different formats including Microsoft Office.
- 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 courses for documents to distribute learning tasks and monitor progress.
- Automatic PDF conversion upon releasing documents.
- Ability to revise released documents with traceable version numbers.
- Automatic archiving for older revisions upon releasing a newer revision of the document.
- Ability to reference related documents.
- Fully configurable Numbering system.
- Fully compliant electronic signatures, that can be automatically synchronized to the body of the attached document.
- Fully compliant audit trail.
- Fully configurable workflows and forms using leading edge No-Code designers.
- Built-in and integrated real time analytics solution that allows creating visualizations and dashboards.
- Cloud based and SaaS (Fully managed), which eliminates the need to deploy internal IT infrastructure, reduces your cost, and saves your time and effort.
- Implementation and data migration services to transfer your data from paper-based or other electronic systems.
audits
Auditing is a key process in all quality standards, internal audits would continuously improve your quality management system, supplier audits are crucial to ensure quality across supply chain.
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.
key features
- Plan and execute audits of multiple types (internal, supplier, external, registrar, and others).
- Create Checklist Templates library so that you reuse them upon executing audits.
- Link your checklists to SOPs and Compliance Requirements like standards and regulations, to ensure full coverage from a compliance perspective, and to give the auditing team quick access to related verbiage during the audit.
- Load checklists in Audits from templates, and assign them to different auditors to accelerate the execution of your audit.
- Your Audit is accessible using any device including tabs and mobiles, to ensure easy access on-site.
- Tracking of all findings with proper classification (Major Findings, Minor Findings, and Opportunities for Improvement).
- Automatic generation of audit summary upon the completion of checklists execution, making it easy for the lead auditor to communicate results in closing meetings.
- Launch CAPAs and Recommendations directly from the audit and assign them internally or externally (e.g., to suppliers) without leaving the system. Assign due dates to ensure timely resolutions and tracking.
- Automatic generation of PDF reports upon closing the audit, allowing you to share results with internal and external parties in an automated fashion.
- Fully compliant electronic signatures.
- Fully compliant audit trail.
- Fully configurable workflows and forms using leading edge No-Code designers.
- Built-in and integrated real time analytics solution that allows creating visualizations and dashboards.
- Cloud based and SaaS (Fully managed), which eliminates the need to deploy internal IT infrastructure, reduces your cost, and saves your time and effort.
- Implementation and data migration services to transfer your data from paper-based or other electronic systems.
change management
Addressing Change to the Quality Management System and its processes is a key focus area in all Quality Management Standards and regulations.
Quality Management System and internal processes should be continuously improved according to the feedback you receive and according to business context adjustments.
Change Management module will help you manage the whole cycle of any change, including identification, assessment, prioritization, planning, execution, training, and much more. Use this module to manage all kinds of changes regardless of their type (Process, Product, Documentation, Supplier, Material, and others).
key features
- Start with initiating the change, linking it back to its original source which could be a CAPA, Deviation, Audit, Customer Complaint, or any other Quality/Compliance process.
- Include information about what needs to be changed by adding any supportive documentation or media files.
- Ensure the requested change is reviewed and approved before you take further steps using a streamlined workflow.
- Follow risk-based approach to prioritize your changes for planning and implementation and focus on implementing changes that will eliminate or mitigate high risks, or those that will introduce best business opportunities.
- Use a fully configurable risk matrix to automatically calculate risk levels based on priority and severity, and document Risk Assessment and Impact Assessment.
- Put together a complete plan to perform the change, and outline tasks that need to be assigned to the team upon performing the change.
- Include references to Documents that need to be revised in your plan, and consider all action items to change impacted processes, equipment, suppliers, and materials. Link to learning courses that need to be performed as part of doing the change.
- After getting the needed approvals, assign planned tasks to the team so that they work on executing all action items in parallel or according to a specified sequence, track due dates, and have visibility on what is completed and what is pending for every Change in your system.
- Finally, verify the change and monitor its effectiveness before you close it, and load additional action items when identified as part of the final check.
- Use our fully integrated analytics solution to have better insight on Changes being performed. Analyze them and make decisions based on real time data coming directly from the system.
- Generate PDF reports and export your data to excel.
- Fully compliant electronic signatures, that can be automatically synchronized to the body of the attached document.
- Fully compliant audit trail.
- Fully configurable workflows and forms using leading edge No-Code designers.
- Cloud based and SaaS (Fully managed), which eliminates the need to deploy internal IT infrastructure, reduces your cost, and saves your time and effort.
- Implementation and data migration services to automatically transfer your data from paper-based or other electronic systems.
Compliance Requirements
Compliance means conforming to a rule, such as a specification, policy, standard or law.
It is important for organizations to keep track of all requirements that they should comply with, that way they can ensure 360 coverage in deployed policies and procedures.
Use this module to reference and document all Requirements that your organization need to comply with regardless of their type:
- Standards: Like the different clauses within the ISO 13485 or ISO 9001 standards for Quality Management.
- Regulations: Like relevant titles of the HIPAA Regulation.
- Internal Policies: Established by an organization to define internal system.
- Guidelines: Like the items within one of the guideline documents that the FDA issues to help related industries.
key features
- Start with creating Compliance Reference records for each high-level requirement that you need to comply with (Example ISO 13485 Standard Reference)
- Within the compliance reference, create related records for each requirement (for example add all clauses within ISO 13485 Standard). For each requirement you can include:
  o Key
  o Title
  o Description - Trace each compliance requirement back to Policies, Procedures, and Work Instructions that ensure coverage of the related compliance requirement. That traceability ensures that you have a solid process in place.
- Review, Approve, and Activate all Compliance References and Related Compliance Requirements.
- Start to use this module as a lookup for Compliance Requirements in other modules and processes. Examples:
  o Reference ISO 13485 impacted standard in a Quality Issue.
  o Reference a specific HIPPA Regulation in an Audit Checklist Template.
  o Reference 21 CFR regulation in a procedure document.
- Fully compliant electronic signatures to capture approvals.
- Compliant audit trail to track changes up to the field level, with traceability on files.
- Configurable workflows and forms using leading edge No-Code designers.
- Built-in and integrated real time analytics solution that allows creating visualizations and dashboards.
- Cloud based and SaaS (Fully managed), which eliminates the need to deploy internal IT infrastructure, reduces your cost, and saves your time and effort.
- Implementation and data migration services to transfer your data from paper-based or other electronic systems.
Tasks
Tasks is a centralized module that can be integrated automatically with any other module in the system to allow launching tasks and assign different individuals to process them in parallel.
For example, in the Change Management module, you could define an action plan by creating tasks of type action items, and then these tasks can be assigned to team members as part of the Change implementation.
key features
- Create tasks from any module within the system, and document what needs to be done.
- Tasks can have different types (Action Items, Recommendations, etc.).
- Take the task through a workflow to ensure effective implementation (Initiation, Implementation, Verification, Effective Check, Closed).
- Tasks can optionally be assigned to external team members like suppliers.
- Automated reminders for tasks based on due dates.
- Fully compliant electronic signatures to capture approvals.
- Compliant audit trail to track changes up to the field level, with traceability on files.
- Configurable workflows and forms using leading edge No-Code designers.
- Built-in and integrated real time analytics solution that allows creating visualizations and dashboards.
- Cloud based and SaaS (Fully managed), which eliminates the need to deploy internal IT infrastructure, reduces your cost, and saves your time and effort.
- Implementation and data migration services to transfer your data from paper-based or other electronic systems.
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