Digital
Transformation made fast
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
EQMS MODULES
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.
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.
quality issues
Use this module to track all Quality Issues and Events regardless of their source. Track internal, customer and supplier issues in a centralized place, contain them, and follow a risk based approach to decide about the need for further actions.
Start with capturing all issues encountered in one place, makes it easier to decide on how to move forward. You can use a systematic decision tree to decide on the types of records that need to be created within your Quality Management System (CAPA, Nonconforming Material, Deviation or others).
key features
- Capture all Quality Issues and Events in a centralized place regardless of their type (Internal, Supplier or Customer)
- Attach images and files to capture information about the issue, and use tablet devices to capture pictures using your device camera.
- Document initial investigation results.
- Draft containment plan and assign tasks to team members to work on containment activities in parallel.
- Assess the risk of the Quality Issue, based on Probability and Severity, and document impact.
- Follow risk based approach to decide about Quality Issues that require further actions after containment.
- Low risk issues can be closed after containment and approval, and let your team focus more on issues that are really important.
- Use a visual decision tree to decide about what needs to be done of the issue is critical, by creating a CAPA, Deviation, or Nonconforming Material.
- Configurable risk assessment matrix and visual decision trees.
- 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.
Corrective And Preventive Actions (CAPA)
Corrective & Preventive actions module is a critical part of your Enterprise Quality Management System. Whether you are dealing with adverse events or trying to prevent them use Cloudtheapp CAPA module to contain issues, assess their risk, drill down on root causes, and monitor effectiveness after implementing your corrective and preventive plans.
key features
- Record all Quality Issues your business encounters and immediately contain them.
- Follow risk based approach to decide about the Quality Issues that require root cause elimination. This will ensure agility and effectiveness of your CAPA implementation.
- Run a streamlined workflow to drill down on root causes and identify them, define your implementation plan, and finally work with the team on root cause elemination to prevent reoccurance and monitor effectiveness.
- Connect with your Suppliers on the same platform without any additional cost and send them Supplier Corrective Action requests without leaving the system, approve communicated root causes and solution plans, and get notified about any lateness in the implementation.
- Our CAPA module is fully integrated with all other modules in your QMS; Auditors can launch CAPAs for Major Findings with a click of a button right after the audit summary meeting; allowing for full traceability and visibility on resolutions.
- Use our real-time fully integrated analytics solution to have better insight on CAPA trends. Analyze them and make decisions that will continually improve the quality of your products and services.
- 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.
Nonconforming Materials
Nonconforming Material is a crucial process in any Quality Management System, regardless of whether you receive the material from a supplier or manufacture it internally, it is so important to decide about what to do with problematic materials that have Nonconformities.
Fixing issues related to materials before they find their way to your final product is important. Not having a solid process for Non conforming Materials could cause serious brand and reputation issues as well as product recalls that could be very costly.
key features
- Starting with a Quality Issue, Inspection, Audit or Any other relevant process within your Quality Management System, trigger the creation of a Nonconforming Material.
- Reference all relevant information like Supplier, Material, PO Details, Problematic Quantity, and much more.
- Carry out an investigation comparing with the agreed on specifications, and decide on recommended actions to be taken regarding the nonconforming Material.
- Have the recommended action reviewed and approved by the relevant departments including Quality.
- In implementation, execute the approved action. You could return the nonconforming material to the supplier, scrap it, rework it, or use it without any changes.
- Verify and ensure effectiveness before you close the Nonconforming Material Record
- Connect with your Suppliers globally on the same platform and send them the Nonconforming Material record for input when needed, with monitored due dates and without leaving the system.
- Our Nonconforming Material module is fully integrated with all other QMS modules.
- Use our real-time fully integrated analytics solution to have better insight of CAPA trends and analyze them. Make decisions that will continually improve the quality of your products and services.
- 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.
- Compliant audit trails.
- 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, reducing your costs, and saving you time and effort.
- Implementation and data migration services to automatically transfer your data from paper-based or other electronic systems.
deviations
As part of managing quality, there could be differences between observed values and expected values for a process or product condition. In other cases, you might face situations in which you have to deviate from a documented standard operating procedure.
Cloudtheapp Deviations Module provides you with means to record and capture these deviations, analyze them, and decide further on how they can be corrected.
Deviations could be triggered by many other processes. Quality Issues reported internally could lead to deviations. In some other cases deviations are triggered based on customer complaints when they inspect products and materials provided by your organization that do not match agreed on specification or communicated certificates.
key features
- Extend Quality Issues by creating Deviation Records.
- Add references to other records in the system that triggered the creation of the deviation record (Quality Issues, Complaints, Inspections, etc.)
- Perform Risk Assessment.
- Classify your deviations:
– Temporary (One Time).
– Temporary (Limited Duration).
– Permanent.
- Take the Deviation through a streamlined workflow to ensure doing proper reviews, approvals, and actions to address the deviation.
- Extend permanent deviations by launching a Change Management record, as the process needs to be changed to reflect what you currently permanently do.
- Our Deviation module is fully integrated with all other modules in your QMS.
- Use our real-time fully integrated analytics solution to have better insight on Deviation trends. Analyze them and make decisions that will continually improve the quality of your products and services.
- 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.
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.
Complaints
Complaint is any report of dissatisfaction (written, oral or electronic) related to the quality, safety, or effectiveness of any manufactured product.
All complaints must be classified, studied, investigated, and responded to according to a well-defined process to ensure quality.
In addition to the different Quality standards, many authorities and regulatory bodies in several countries mandate having a well-defined process to investigate complaints, and according to how the complaint is classified it could be required by regulations and laws to have complaints reported and communicated to regulatory bodies and authorities.
Cloudtheapp Complaints modules can be used to deploy a solid process for handling complaints.
key features
- Provide your end product or service consumer with ways to feed your complaints process.
- Generate a QR code and print it on the product or in service locations, allowing consumers to scan it using any mobile device camera to fill and submit complaint information and photos. Integrating with public consumers have never been easier.
- Complaints can also be created directly in the system, if the complaint was communicated by the customer using a different mean (Phone call, email, social media, etc.).
- Reference problematic product, batches and lots using a direct lookup function.
- Follow risk-based approach in deciding about how to handle the complaint. Launch a risk assessment record, fill probability and severity, and use predefined and configurable risk assessment matrix or cube to have the risk level calculated automatically for you.
- Decide about whether a Regulatory Reporting is required (eMDR, FAR, etc..), and document information about initial and follow up submissions.
- Carry out a systematic investigation and record results along with all traceable information, photos and attachments.
- Define the action plan and corrective actions and take it through approval.
- Address the complaint by implementing an action plan and defined CAPAs. Assign tasks in an organized way with due dates to have the team working address the complaint quickly and thoroughly.
- Notify complainant before taking the complaint through closure.
- 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.
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.
Inspections
Inspection is an essential part of quality control in manufacturing.
Characteristics of a product, material, or process are examined, and compared with specified requirements to ensure compliance.
Use Inspections module to design templates for repetitive inspection types, and then have all inspection records created digitally using predefined templates.
key features
- Create Inspection Templates for the different inspection types. Within each inspection template.
- In each Inspection template, define the different items that need to be inspected, and attach files and photos, to guide the inspector visually when they perform the inspection.
- Link your inspection templates to related work instructions and compliance requirements.
- Review and Approve Inspection Templates to end up with a library of templates that inspectors can use for everyday inspections they perform.
- Inspectors can use tablet devices to perform inspections, and they can access a QR Code for a quick launch of inspection record.
- Inspectors can select a template from a library, which would load all inspection items with guidance pictures attached for each item to be inspected.
- Inspectors would record results (Pass, Fail, NA) for each item, and document objective evidence or findings.
- The final result of the inspection is automatically calculated, and the inspection record can be then optionally assigned to a supervisor to review results.
- Additional quality records can be launched to take additional actions (CAPA, Nonconforming Material, etc.).
- Inspection records can also be linked to Material Receiving records for full trackability.
- 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.
Equipment
When it comes to Quality Management, ensuring that you have the right set of quality control practices around equipment used to manufacture your products is so important.
In many industries, equipment plays a key role in the final product quality. In the age of Industry 4.0 equipment, robots and machines handle the manufacturing process from A-Z. So, ensuring implementing the right Quality practices around equipment is critically important to end up with the desired product quality.
You can use Cloudtheapp Equipment module to track equipment and devices, ensure they were installed correctly, and track their maintenance and calibration to obtain maximum desired performance and quality output.
key features
- Create equipment profiles to track all equipment and devices in your manufacturing facility.
- Track device information like (Serial number, Model, Manufacturer, Cost, etc.).
- Track standards that are used to calibrate other devices.
- Attach important files and pictures related to the equipment, like Manual, Installation Qualification, Work Instructions.
- Generate a QR code, and place it on the device. Use your tablet or mobile device camera to scan it and quickly access Equipment Profile in the system.
- Define equipment calibration settings, including:
o Calibration Instructions
o Calibration Template
o Reference Materials
o Calibration Frequency - Define equipment maintenance settings, including:
o Maintenance Instructions
o Maintenance Template
o Reference Materials
o Maintenance Frequency - Launch Calibration Records, and have them referenced in the Equipment Profile. Set next calibration date based on Frequency, and let the system remind you when a new calibration is due.
- Launch Maintenance Records, and have them referenced in the Equipment Profile. Set the next maintenance date based on Frequency, and let the system remind you when a new maintenance is due.
- 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.
Calibration and Maintenance
Calibration is the comparison of measurement values delivered by a device under test with those of a calibration standard of known accuracy. Calibration is a key process in any Quality Management System to ensure quality and consistency of delivered products.
Maintenance is also an important quality process. Equipment used in product manufacturing must be maintained based on predefined frequency.
Use Cloudtheapp Calibration and Maintenance module to manage these processes. With seamless integration with Equipment module and other modules in QMS, obtain highest levels of Quality related to your products and services.
key features
- Create measurement templates, that contain sheet templates for recording measurements related to nominal points as part of carrying out the calibration procedure. Include:
o Nominal Points
o Unit
o Tolerances (min, max)
o Lower and Upper Limits. - Launch Calibration Records directly from the Equipment Profile. This will load calibration measurements sheet based on a predefined template, and it will load all needed information like work instructions, standard equipment references, and much more.
- Assign a calibration record to the team (internal or external) that is responsible for carrying out the calibration procedure.
- Calibrate the device and fill “As Found” and “As Left” measurements for each nominal point.
- Take the record through final review and approval before you return the device back to use.
- Create maintenance instruction templates for the different device types you have within the manufacturing facility.
- Launch Maintenance Records directly from the Equipment Profile. This will load maintenance instructions automatically within the record.
- Assign maintenance records to the team (internal or external) that is responsible for carrying out the maintenance procedure.
- Maintain the device based on listed instructions, and record the final status (Pass/Fail).
- Take the record through final review and approval before you return the device back to use.
- 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.
Suppliers And Materials
Suppliers are entities that provide their products or services to your entity. Supplier Quality Management is an essential part of the overall quality management as the materials they provide could impact the quality of your entity’s products and services.
It is important to establish and furnish processes that ensure selecting the right suppliers who are able to deliver goods and services that will satisfy your customers’ needs, and then manage their quality across the supply chain.
This centralized module wraps workflows to get suppliers and materials to your approved lists.
The app is tightly integrated with other modules for better management of suppliers. For example, in a Supplier Corrective Action Request (SCAR), you can select the related Supplier from your approved suppliers listed in this module.
On-board your approved suppliers on Cloudtheapp Platform without any extra cost to send your suppliers records to process as part of a streamlined workflow and without leaving the system.
key features
- Launch Supplier records and take them through a streamlined workflow to have them on your Approved Suppliers List.
- Capture supplier information in a centralized profile for each supplier (Addresses, Phone Numbers, NDAs, Certificates, etc.).
- Integrate with Supplier Qualification Management module, to launch qualification records for the supplier. Use this well-organized selection, evaluation and approval process to Qualify your supplier.
- Without any additional cost to license their users, invite your approved suppliers to create their own teams on Cloudtheapp platform, and establish a B2B connection with them, to send Quality and Compliance records to them to process without leaving the system.
- Launch Material records and take them through a streamlined workflow to have them on your Approved Materials List.
- Capture material information (Classification, Specification, Attachments and Photos, etc.).
- Reference all suppliers that supply a specific material.
- Integrate other Quality processes with Suppliers & Materials module to easily lookup approved suppliers and materials, and then use our Embedded Analytics solution to measure the performance of your suppliers.
- 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.
Customers and Products
Customers are organizations that your entity provide with products and services. It is important to track customers within your implementation so that you can reference them in other records within the system, for example, when a Complaint record is created, the related customer might need to be referenced.
Tracking products is as important as tracking customers, workflows can be created to capture information related to product release steps. Products can also be referenced in other records within the system (e.g. product could be referenced in a Corrective Action).
key features
- Launch Customer records and take them through a streamlined workflow to have them on your Approved customers List.
- Capture customer information in a centralized profile for each customer (Addresses, Phone Numbers, Agreements, etc.).
- Reference contacts for each customer.
- List products that are related to the customer.
- Allow customers to feed your process with information using QR Codes that can be printed on the product. For example, a customer can scan QR Code on the product using mobile camera to submit a complaint.
- Create Customer records and take them through a streamlined workflow containing all steps in your product release cycle.
- Capture product related information like (Category, Brand, SKU, Dimensions, etc.).
- Integrate other Quality processes with Customers and Products module to easily lookup approved customers and products, and then use our Embedded Analytics for trending analysis.
- 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.
Laboratory Testing
Quality Control Laboratory Testing serves an important function in Pharmaceutical, Biotechnology, Food Production, and many other industries.
Whether used to test Chemicals and Materials to confirm compliance with specifications, or to test finished product samples; a Lab Test module can be used to do thorough testing that complies with standards and regulations.
With Cloudtheapp’s Laboratory Testing module, automating QC processes within labs has never been easier.
key features
- Setup Lab Submission Templates for each type or Material or Product.
- Setup Test Templates for each Submission Type and take them through approval cycle before you use them in actual tests.
- In each Test Template, specify the Test Items, and acceptance criteria, upon doing the actual test.
- Acceptance criteria could be a simple Pass/Fail or a numeric condition (e.g. <10000 cell/mg)
- With our thorough revision control system, revise templates to comply with latest modified product, material spec, and standards.
- Laboratory QC groups can load tests from predefined templates each time a sample is submitted to the lab.
- After doing proper testing for each item, actual values can be recorded, and get automatically compared with the expected result to pass/fail each item within the test.
- QC and Lab Professionals can use tablets to record the test results, while taking photos using the device camera to record objective evidence.
- Once all tests get executed, results are rolled up to a Lab Sample Submission report, showing detailed results for each item, as well as the overall result.
- Automatically generate a full PDF report for all tests done along with results for each item within the tests.
- Launch Quality Issues directly from the Lab Testing App, and extend them to CAPAs or Nonconforming material if needed with full traceability for the different records created.
- 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 costs, and saves your time and effort.
- Implementation and data migration services to transfer your data from paper-based or other electronic systems.
Batch Records
Batch production is an approach to manufacturing where the products are made as specified groups or amounts, within a certain time frame.
Batch production is used in many types of manufacturing that may need smaller amounts of production at a time to ensure specific quality standards.
Batches are assigned specific and unique batch numbers, and a batch can optionally be divided into multiple lots that are traceable by number as well.
When quality issues related to specific items are reported, it will be possible to trace the issue back to a specific product batch, which could be particularly useful in scenarios like product recalls where traceability is key.
Use the Batch Records module to manage the process of tracking and releasing batches and lots.
key features
- Create Batch records and link them to products.
- Track information about batches, like (Batch Number, Country of Origin, Plant, Issue Date, Expiration Date, Manufactured Quantity, and much more).
- Setup an automated workflow to govern the release process of batches.
- Create Lot records related to the batch and assign each Lot additional information such as Number and Produced Quantity.
- Lookup and reference Batches and Lots in other deployed apps within the system. For example, when a Complaint is created, you can reference affected Batches and Lots, which will be very helpful in investigation.
- 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.
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.
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.
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.
Management Review
Management review is the process of periodically reviewing the Quality Management System by top management to ensure its suitability, adequacy, and effectiveness. Management Review is a requirement in several quality standards and regulations such as ISO-9001 and ISO 13485.
Cloudtheapp Management Review App allows organizations to run management review meetings in an organized and effective way.
The Management Review App is integrated with our analytics solution that enables management to view the organization’s performance for the different functions in an organized and real-time way.
key features
- Launch a digital record for the Management Review meeting.
- Capture key information related to your Management Review, such as Chair, Participants, Start and End Dates, Location, etc.
- Setup the meeting agenda by including agenda items containing the information that is required to kick off the discussion for each topic. Include things like:
o Key discussion points.
o Objectives and Metrics to be met.
o Graphs and visualizations.
o Access to real-time built-in graphs and QMS data.
- The management team can easily conduct meeting sessions to go through the agenda items one by one in an organized way.
- Without having to navigate to different places, you can find all information about each agenda item in one place (Attachments, Slides, Visualizations, Metrics, etc.).
- Managers can navigate to dashboards powered by Cloudtheapp Analytics, to review data related to key processes, drill down to get insights, and make decisions driven by real-time data.
- Document minutes for each agenda item in an organized way highlighting action items.
- Document the summary of your Management Review.
- Based on meeting minutes, launch action items, and corrective actions with clear ownership and timeline for resolution.
- Use a streamlined workflow and assign the record to the management team to sign off digitally.
- Now it is time to close the record. Action Items and CAPAs will be kept open to be worked on and reviewed in the following meeting.
OOS (Out of Spec)
Whether you are testing samples of product-released batches or materials/ingredients, there could be cases where the test result is not in-line with the expected result. These cases require performing an investigation to drill down on the root cause(s) and decide about the disposition of the problematic batch or ingredient, before additional damage happens.
Investigating OOS cases is essential to quality, and the practice is expected in GMP environments, and required by several regulations and standards.
Out of Specification (OOS) can be used to digitally record and investigate OOS cases, using a streamlined, digitalized, and intuitive workflow.
key features
- Launch Out of Specification (OOS) records and record information about the issue including Subject, Description, Attachments, and Photos.
- The OOS module is tightly integrated with the Lab Testing module and other deployed modules, and the record of the OOS can be launched directly from the lab test record with dual linking between the two.
- For Product-related OSS, reference related Product, Batch, and Lot by doing a lookup on related deployed modules that contain this data.
- For Material-related OOS, reference the Supplier, Material, and Material Lot Number by doing a lookup on related deployed modules that contain this data.
- Record additional details of the OOS like Process Step, Temperature Condition, Sample Number, Sample Receiving Date, Parameter, Specification, OOS Result, and much more.
- Reference related Test Method documents from Document Control and launch a Risk Assessment record to follow a risk-based approach in doing the investigation.
- Move the record to the investigation step within a streamlined workflow after an approval sign-off by the lab management.
- Perform a deep investigation of the OOS case and record investigation results in related sections attaching any files or objective evidence photos.
- Provide the recommendation on how to proceed with disposing of the batch or the ingredient and move it forward to management to approve before actually performing it.
- Link the OOS record to related or resulting Deviations, CAPAs, and other records within the deployed EQMS.
- 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 costs, and saves your time and effort.
- Implementation and data migration services to transfer your data from paper-based or other electronic systems.
Design Controls
The Design Controls module has been designed to ensure compliance with various regulatory requirements and standards, including ISO 13485, FDA 21 CFR Part 820, and EU MDR.
The module helps organizations to effectively manage the design and development process of medical devices by providing a systematic approach to design controls. It enables organizations to document and track the design inputs, design outputs, and design changes in a centralized location, while also facilitating the design review and verification processes.
Overall, the Design Controls module helps organizations achieve and maintain compliance with relevant standards and regulations, while also ensuring that their medical devices are safe, effective, and of high quality.
key features
- The module Enables medical device manufacturers to create, manage, and track all aspects of the design control process.
- Begin by tracking and documenting the user needs for your medical device or product.
- Ensure that design inputs are mapped to user needs and that these requirements are clearly identified and tracked throughout the design process.
- Document design outputs and map them back to their corresponding design inputs, including device specifications, drawings, schematics, bills of materials, manufacturing instructions, assembly instructions, packaging, labeling, and risk mitigation strategies.
- Conduct design reviews, documenting the design elements covered, and capturing meeting minutes, action items, and changes resulting from the review.
- Manage design changes holistically, obtaining approval and executing changes for design inputs and outputs as needed.
- Perform design verification to ensure that design inputs are met.
- Conduct design validation to ensure that all user needs are satisfied.
- Establish a design risk register, assess each risk, and implement necessary design changes to mitigate risks to an acceptable level.
- Traceability Matrix Auto Generation feature, which automatically generates a traceability matrix that links user needs, design inputs, design outputs, and verification and validation activities.
- Automatic Generation of Design History File feature, which generates a comprehensive and up-to-date Design History File (DHF) for each medical device.
- Powered by real-time analytics and dashboards, which provide users with the ability to visualize data and gain insights.
- Fully integrated with other aspects of the Quality Management system, such as Document Control, Change Control, and CAPA Management.
- Highly configurable, allowing each customer to tailor the module to their specific needs and processes, ensuring compliance with regulatory requirements in a way that works best for them.
Bill of Materials
Welcome to Bill of Materials module, the ultimate solution for managing and optimizing your Bill of Materials. Our powerful app is designed to streamline your BOM processes, saving you time and effort while improving efficiency and accuracy. Whether you’re a small business or a large manufacturing enterprise, our app is tailored to meet your BOM management needs.
key features
- Centralized BOM Repository: Easily create, store, and manage all your BOM data in a single, organized repository. Say goodbye to scattered spreadsheets and disconnected documents.
- Version Control: Maintain complete control over your BOM revisions. Track changes, and ensure you’re always working with the most up-to-date information. Avoid costly mistakes and production delays caused by outdated or conflicting BOMs.
- Collaboration and Workflow: Foster seamless collaboration across teams and departments. Assign roles, set permissions, and enable real-time collaboration on BOMs. Keep everyone in sync and eliminate communication gaps.
- Component Management: Effortlessly manage your items and materials. Easily add new items in the right location within the BOM structure.
- File and Document Management: Simplify BOM management by attaching and linking relevant files and documents directly to your BOM records. With this feature, you can easily associate CAD files, technical specifications, datasheets, and other supporting documentation with the corresponding components or assemblies in your BOM.
key Benefits
- Increased Efficiency: Our app eliminates manual processes, reduces errors, and saves valuable time. Automating BOM management tasks allows your team to focus on more strategic and value-added activities.
- Improved Accuracy: With centralized data and version control, you can ensure accuracy and consistency throughout your BOMs. Minimize errors, rework, and production delays, ultimately improving the quality of your products.
- Enhanced Collaboration: Enable cross-functional collaboration and improve communication between teams involved in the BOM process. Everyone stays on the same page, resulting in smoother operations and faster time-to-market.
- Optimized Cost Management: Accurate cost estimation and component tracking help you make informed decisions and optimize your procurement and production processes. Identify cost-saving opportunities, reduce waste, and maximize profitability.
- Scalability and Growth: Our app scales with your business needs. Whether you’re a startup or a large enterprise, you can easily handle increased BOM complexity, manage multiple product lines, and adapt to changing market demands.
By leveraging the power of our Bill of Materials app, you can revolutionize the way you manage, collaborate, and optimize your BOM processes. Experience the benefits of increased efficiency, improved accuracy, and streamlined operations.
Defects
The Defects module is a powerful tool designed to assist organizations, particularly in the electronics manufacturing industry, in efficiently recording and tracking defective items. Whether triggered by inspections, finished product testing, or other sources, this module empowers businesses to gain valuable insights into their processes, improve product quality, and drive continuous improvement. By leveraging integrated analytics, organizations can identify trends, prioritize corrective actions, and work towards a 0 defect initiative, aligning with quality standards like ISO 9001.
key features
- Record Defects: The Defects module allows users to easily record crucial information about defective items. This includes details like Serial Number, Work Order (WO), and links to specific products such as Assemblies, Parts, or Printed Circuit Board Assemblies (PCBAs). Capturing this data provides a comprehensive overview of the defects and their association with specific products or production batches.
- Defect Types and Locations: Users can specify various Defect Types and Defect Locations for each recorded issue. This level of granularity enables organizations to pinpoint recurring problems and identify areas within the product where most defects occur. Such insights are invaluable in developing targeted quality improvement strategies.
- Integrated Analytics: The Defects module integrates powerful analytics tools that transform data into actionable insights. With customizable reports and visualizations, users can easily access information like Top Defect Types, Top problematic products, and the most common Defect Locations. These analytics empower decision-makers to prioritize resources effectively and implement impactful changes.
- Versatility Across Industries: While initially tailored for the electronics manufacturing industry, the Defects module’s versatility extends to various other sectors. Organizations with quality management needs, regardless of their industry, can leverage this module to bolster their efforts in identifying and rectifying defects.
- Seamless Integration with Cloudtheapp Platform: The Defects module seamlessly integrates with the Cloudtheapp platform, enhancing its capabilities through cross-module data exchange. Users can easily combine data from the Defects module with information from other relevant modules, such as Product, Batch Records, and Shipments. This holistic approach streamlines processes and fosters a cohesive ecosystem for efficient quality management.
- Take Control of Quality with the Defects Module: Embrace the power of data-driven quality management and continuous improvement with the Defects module. By implementing this feature-rich tool, organizations can elevate their product quality, optimize processes, and enhance customer satisfaction. The Defects module, together with the comprehensive Cloudtheapp platform, propels businesses towards success in quality-driven markets.
key Benefits
- Improved Quality Management: By efficiently tracking and analyzing defects, organizations can take proactive measures to improve product quality. The data obtained from the Defects module feeds into the Quality Management System (QMS) and supports the organization’s pursuit of a 0 defect initiative, fostering a culture of continuous improvement. Targeted Corrective Actions: Identifying Top Defect Types and problematic products enables organizations to prioritize corrective actions. By focusing resources on the most critical issues, the module aids in maximizing the impact of improvement efforts.
- Enhanced Compliance: The Defects module aligns with ISO 9001 and other quality standards and regulations. By maintaining accurate defect records and implementing effective corrective actions, organizations can achieve and maintain compliance while adhering to industry best practices.
- Optimized Resource Allocation: Through integrated analytics, businesses gain a clear understanding of their defect trends. This knowledge allows for optimized resource allocation, reduced waste, and increased overall operational efficiency.
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.
Advanced Inspections
The Advanced Inspections module is a powerful tool designed to streamline and enhance your organization’s quality control processes. Whether you need to adhere to industry standards like ANSI/ASQ Z1.4 or require flexible inspection templates, this module empowers you to efficiently manage inspections, make data-driven decisions, and integrate seamlessly with your Quality Management System (QMS).
key features
Sampling Plan
- Plan your inspection samples according to ANSI/ASQ Z1.4 standards.
- Link Inspection Sample records to product or material Batch#, and define batch size and AQL (Acceptable Quality Limit).
- Utilize ANSI/ASQ Z1.4 tables to determine Sample Size, Acceptance Number (Ac), and Rejection Number (Re).
- Empower inspectors to link Templated Inspection Records to the Sample and automatically evaluate inspection results (Accept Batch, Reject Batch, or Request a New Sample).
- Effortlessly manage multi-sampling plans by creating a chain of linked Sample Records based on ANSI/ASQ Z1.4 standards.
Inspection Templates
- Create Inspection Templates for various types of inspections, including Receiving, In-process, First Article, and Final Inspections.
- Develop Multi-Checklist Inspection Templates for different products and templates.
- Define inspection parameters for each checklist and attach visual aid images to guide inspectors.
- Set expected values for each Inspection Parameter, whether Pass/Fail or numerical ranges for measured values.
- Streamline your workflow by reviewing and approving Inspection Templates, building a library for everyday inspections.
Inspections
- Inspectors can perform inspections using tablet devices, with easy access to QR Codes for quick launch of inspection records.
- Record results for each Inspection Parameter, including Pass/Fail criteria or numerical measured values.
- Capture comments and images to provide detailed context for inspection results.
- Lookup and reference the Sample within the Inspection Record, automating decision-making regarding batch acceptance, rejection, or re-inspection.
- Seamlessly integrate with other EQMS modules, such as Receiving, Non-Conformance Reports (NCR), Corrective and Preventive Actions (CAPA), and more.
- Enjoy an extremely configurable workflow and form design using state-of-the-art No-Code designers.
- Capture compliant electronic signatures to streamline approval processes.
- Maintain a compliant audit trail, tracking changes down to the field level, with full traceability on files.
- Access a built-in and integrated real-time analytics solution for creating visualizations and dashboards.
- Benefit from a cloud-based and Software as a Service (SaaS) solution, eliminating the need for internal IT infrastructure, reducing costs, and saving time and effort.
key Benefits
- Improved Quality Management: Efficiently track and analyze defects to take proactive measures for improving product quality. Data obtained from the Advanced Inspections module feeds into your Quality Management System (QMS), supporting your organization’s pursuit of a “0 defect” initiative. This fosters a culture of continuous improvement.
- Targeted Corrective Actions: Identify Top Defect Types and problematic products, enabling your organization to prioritize corrective actions effectively. By focusing resources on the most critical issues, the module aids in maximizing the impact of improvement efforts.
- Enhanced Compliance: The Advanced Inspections module aligns with ISO 9001 and other quality standards and regulations. By maintaining accurate defect records and implementing effective corrective actions, your organization can achieve and maintain compliance while adhering to industry best practices.
- Optimized Resource Allocation: Through integrated analytics, businesses gain a clear understanding of their defect trends. This knowledge allows for optimized resource allocation, reduced waste, and increased overall operational efficiency.
- Seamless Integration: The Advanced Inspections module seamlessly integrates with all other EQMS (Enterprise Quality Management System) modules, such as Receiving, Non-Conformance Reports (NCR), Corrective and Preventive Actions (CAPA), and more. This integration creates a cohesive ecosystem for efficient quality management, ensuring that data flows seamlessly across your quality control processes.
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