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.
FMEA
The FMEA module is a powerful tool designed to empower organizations across various industries with a systematic approach to risk assessment. Particularly relevant for the electronics manufacturing industry, this module enables businesses to proactively identify potential failure modes, their causes, and their effects on systems, processes, or products. By leveraging integrated analytics, organizations can gain valuable insights, prioritize corrective actions, and drive continuous improvement. The FMEA module aligns with quality standards like ISO 9001, providing a robust framework for achieving operational excellence.
key features
- Comprehensive Risk Assessment: The FMEA module allows users to conduct a comprehensive risk assessment by categorizing functions and identifying potential failure modes. This level of granularity provides a deeper understanding of risks, enabling organizations to focus on critical areas for improvement.
- Efficient Data Capture: Users can easily record essential information about potential failure modes, including their descriptions, causes, and effects. This data capture ensures that critical risk-related information is systematically documented for analysis and decision-making.
- Risk Priority Number (RPN) Calculation: The FMEA module calculates the Risk Priority Number (RPN) for each identified failure mode. By prioritizing potential failures based on RPN, organizations can allocate resources effectively and address high-risk areas promptly.
- Integrated Analytics: Integrated analytics tools empower organizations to derive actionable insights from FMEA data. Customizable reports and visualizations help decision-makers identify patterns, trends, and critical areas for improvement.
- Versatility Across Industries: While initially tailored for electronics manufacturing, the FMEA module’s versatility extends to various other sectors. Any organization prioritizing risk assessment and continuous improvement can leverage this powerful tool.
- Seamless Integration with Cloudtheapp Platform: The FMEA module seamlessly integrates with the Cloudtheapp platform, facilitating data exchange across modules. This integration creates a cohesive ecosystem for risk-driven quality management and compliance.
- Collaborative Risk Assessment: The FMEA module facilitates collaborative risk assessment by enabling multiple stakeholders to participate in the analysis process. Cross-functional teams can collaborate in real-time, sharing insights and expertise to identify and address potential failure modes comprehensively.
- Customizable Risk Scoring Criteria: Organizations can tailor risk scoring criteria to match their specific needs and industry standards. By customizing risk scoring, businesses can align FMEA outcomes with their risk management strategies and objectives.
key Benefits
- Proactive Risk Mitigation: With the FMEA module, organizations can proactively identify and address potential failure modes before they impact product quality or process efficiency. This proactive approach minimizes risks and enhances overall operational reliability.
- Data-Driven Decision-Making: Integrated analytics provide organizations with data-driven insights to prioritize resources and implement impactful changes. This fosters a culture of continuous improvement and ensures resources are allocated where they are most needed.
- Enhanced Product Safety: The FMEA module plays a critical role in enhancing product safety. By identifying and mitigating potential failure modes early in the design and production stages, organizations can reduce the risk of safety-related incidents and recalls, instilling trust among customers and regulatory bodies.
- Improved Product Quality and Customer Satisfaction: By identifying and addressing potential failure modes, organizations can improve product quality and reliability. Enhanced product quality leads to increased customer satisfaction, fostering brand loyalty and repeat business.
learning
Learning is an essential part of any business in today’s world, use this module 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.
Effective employees training is important to comply with many standards and regulations, including standards for Quality Management. Setting up training requirements and objectives to ensure employees can perform their job and ensuring that training is delivered to employees in timely manner is crucial for any Quality Management System.
With powerful integration features between Documents and Learning modules, tracking training for your SOPs has never been easier.
key features
- Start with creating plans to define learning objectives and requirements that should be met based on Location, Department, and Job Position of employees.
- Regardless of whether you want to perform Instructor Led or Self Learning courses, setup Course Templates embedding information about the course, like Material, Potential Trainers, Agenda, and much more.
- Create and schedule Instructor Led Courses, based on templates catalog, let the system discover invitees based on applicability by Location, Department, or Job Position.
- Load learning records for Instructor led course attendees and mark them as Pass/Fail upon course completion.
- Create and schedule Self Learning Courses, based on templates catalog, let the system discover invitees based on applicability by Location, Department, or Job Position. Embed self learning material which could be a document, microlearning video, or any other material type.
- Distribute self learning tasks and allow employees to complete their learning and fill an acknowledgement that they completed their learning for a particular course.
- Enabling automatic integration between documents and learning to ensure your employees are fully aware and trained on all Policies, Procedures, Work Instructions, and other documents before you make them effective. This will ensure highest Quality output.
- Create custom quizzes for document-based self-learning courses.
- Set the number of allowed retakes in case of unsuccessful attempts.
- Integrate quiz completion as a requirement for successful self-learning completion.
- Provide employees with a personalized self-paced learning experience through quizzes.
- Track employee progress and quiz results for assessment and evaluation purposes.
- Enhance the overall efficiency and effectiveness of self-directed learning.
- In audits, showing auditors an evidence that employees completed their training in timely manner has never been easier.
- Navigate to employee profiles to find a list of all pending learning tasks and completed ones. Follow up with employees or have them automatically be notified to ensure learning completion according to due date.
- Lists of all pending and completed learning tasks by employees can be shown in the module views, you can filter them in different ways for better insight on learning progress of your team.
- Built-in and integrated real time analytics solution that allows creating visualizations and dashboards to show learning data in different ways, this will give users graphical information about their learning progress, and it allows you to figure out learning issues and to correct them.
- 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 transfer your data from paper-based or other electronic systems.
Processes
Organizations usually have a set of processes that define how they achieve end results and goals.
Use this module to list and capture information about the main processes within your organization and link these process records to related documentation in the Documents modules (SOPs, Work Instructions, etc.).
The main advantage is that you will be able to reference related processes in other modules in the system. For example, when you could reference the manufacturing process as part of creating a Nonconforming Material record.
key features
- Initiate a process record and capture all information that is related to the process like related products, or related facility.
- Take the process record through the design step, in which you could draft and link all related documentation like SOP.
- In the implementation step of the workflow, execute on all action items needed to roll out the process. For example, purchasing and deploying related equipment that are needed to perform process steps.
- Once the tour process is deployed and approved, it should be possible to reference the process in other module records.
- 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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