SUPPLIER Quality
Management
Cloudtheapp offers a complete, and fully integrated supplier management solution.
SQM MODULES
Supplier Qualification Management
To ensure product highest quality level, organizations should pay close attention to how they select and approve their suppliers. The selection process is complicated and becomes hard to manage without the right system in place.
Qualifying and requalifying suppliers involve many steps like Screening, NDA signing, RFx Input, Assessment, Audit, Evaluation and much more.
Use this module to automate and digitalize the whole process and rest assured that results will be accurate and systematic, leading to better quality and better reputation for your brand.
key features
Supplier Selection Programs:
- Create and launch multiple qualification programs to address the different supply needs for your business.
- As part of every program, you will take several potential suppliers through the selection and qualification journey to arrive at selecting one or more suppliers for that particular need and have them on your approved list.
- Within each program, define the trigger, which is the reason why you need to onboard new suppliers or requalify them whether it is for a new product, part, scale capacity, or for cost reduction.
- Define templates that will be used as part of each supplier qualification process, things like NDA, RFx, Assessments, and more.
- Setup evaluation mechanism. What department and functions will be evaluating each supplier, what weight will be assigned for each function and so on.
Supplier Qualification:
- Create a supplier qualification record for each supplier that you would like to on-board or re-qualify, and link that record to a selection program which will load all the templates you will need as part of the qualification process.
- Optionally on-board suppliers you are evaluating on the platform without extra cost, and exchange qualification records with them to collect information without leaving the system.
- Screening: Start the process with screening, by collecting 360 background information about the supplier, and decide whether you would like to continue the qualification journey or not.
- NDA: Use automatically loaded NDA activity to have the supplier signing it. Signed NDA will be kept automatically in the system.
- RFx: Next, RFx activities (also automatically loaded from program), can now be worked on, and you can assign RFI, RFP or RFQ to the supplier to fill and send back (all within the system).
- Assessment: Have the supplier fill a self- assessment to evaluate their quality system and business processes.
- Audit: Optionally audit the supplier, by launching an Audit record within the Audits module.
- Evaluation: Evaluation records will be automatically loaded based on the setup in the parent program, these records will be assigned automatically to the different functions to evaluate and score. The overall weighted score will be automatically calculated.
- Decision: Making the final decision is now an easy task, and you can make a decision by comparing the evaluation scores of the different suppliers that you are on-boarding as part of the same program.
- 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.
Material Lot Records
Tracking Lot information for materials that you receive from suppliers is a cumbersome task especially if there is no electronic system to handle it.
It is crucial that the supplier shares this information for every material shipment. For example, you might need to verify Certificate of Analysis for every Lot related to a material shipment before you use it as part of your manufacturing process.
This App provides you with ways to allow your supplier to share this information electronically, and then you can reference submitted material lots in other records within the system (example, Material Receiving Records).
key features
- Setup a public URL (or a QR Code), and share with your suppliers so that they use it to submit Material Lot Information before the shipping process starts.
- Supplier can share the following information for each Lot:
– Batch Number.
– Lot Number
– Manufacturing Date
– Expiration Date
– Certificate of Analysis
– Any other relevant certificates or supportive documentation. - After initial submission by the supplier (as a connected team), Material Lot Record gets assigned to your team for review and processing.
- Optionally, you can send the LOT record back to the supplier (if you have feedback on what was submitted)
- Material Lot Record can then be approved, and the information will be available for lookup from other modules within the system (example, Reference Material Lot in the Receiving Record).
- 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.
Receiving
“Materials Receiving” is the process of checking items delivered by suppliers, this includes inspecting the quality, and quantity of any incoming materials, and allocating them to a storage space in the warehouse.
Receiving process also helps in tracking accepted and rejected quantities, this data can be helpful in evaluating suppliers and rating them.
key features
- Track information about every received shipment, like:
– Receive date
– Quantity
-Supplier Information
-Material Information
-Material Lot Information - Lookup Material Lot Information dynamically, based on data submitted electronically by the supplier. Check Lot Certificates (e.g., certificate of analysis) before moving further with the receiving process.
- Launch an Inspection Record based on a template for the material type. Assign to an inspector to go through inspection items one by one to ensure quality and confirm quantity.
- Launch Quality Issues in case of problems and extend them to:
– SCAR (Supplier Corrective Action Request): To eliminate root cause of the issue.
– NC (Non-conforming Material): To dispose problematic material. - Record Accepted and Rejected Quantities and take the record through approval.
- Assign to Warehouse Team to record information about storage location and conditions.
- 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.
Inventory Management
Welcome to the Inventory Management Module, a powerful tool designed to streamline and optimize your inventory tracking and control processes. This module offers a solution for managing your organization’s materials and parts, ensuring efficient inventory management and minimizing stock-related challenges. By utilizing this module, you can enhance productivity, reduce costs, and make informed decisions based on accurate and up-to-date inventory data.
key features
- Record Incoming Quantity of Materials: Easily track and record the quantity of materials or parts received into your inventory. This feature enables you to maintain an accurate count of incoming items, ensuring that your stock levels are always up to date. Integration with the Receiving module automates the process, seamlessly updating the inventory records with each receiving transaction.
- Record Used Quantities of Materials: Keep track of the quantities of materials or parts consumed or used in your production processes. By recording the usage of materials, you gain insight into the depletion rate and can better plan for replenishment. Integration with the Batch Records module allows for automatic recording of used quantities for each batch manufactured, ensuring precise inventory tracking.
- Integration with Receiving Module: The Inventory Management module is seamlessly integrated with the Receiving module, providing a cohesive workflow for managing incoming quantities. This integration triggers the recording of incoming quantities for each receiving record, eliminating the need for manual data entry and reducing the likelihood of errors.
- Integration with Batch Records: Streamline your inventory management by integrating the Inventory Management module with the Batch Records module. This integration automatically records the used quantities for each batch manufactured, eliminating manual tracking and providing real-time visibility into material consumption during the production process.
- Integrated Analytics and Dashboards: Gain valuable insights into your inventory with the power of integrated analytics and intuitive dashboards. The Inventory Management module provides detailed graphs and visualizations, allowing you to compare incoming and used quantities for any material or part. These analytical tools enable you to make data-driven decisions, optimize inventory levels, and order new quantities at the right time, avoiding stockouts or excess inventory.
key Benefits
- Improved Inventory Accuracy: By leveraging the Inventory Management module, you can maintain accurate and reliable inventory records. Real-time tracking of incoming and used quantities ensures that your inventory levels reflect the actual stock available, minimizing discrepancies and avoiding costly errors.
- Enhanced Operational Efficiency: The processes provided by this module eliminate manual data entry and reduce the risk of human error. This efficiency improvement saves time and resources, enabling your staff to focus on value-added tasks rather than tedious inventory management.
- Optimized Inventory Planning: With integrated analytics and dashboards, you gain a comprehensive view of your inventory trends and consumption patterns. This insight empowers you to make proactive decisions regarding stock replenishment, ensuring that you order new quantities at the right time to maintain optimal inventory levels and avoid stockouts or overstock situations.
- Cost Reduction: Efficient inventory management leads to cost savings. By accurately tracking material usage and optimizing inventory levels, you can minimize excess stock, reduce carrying costs, and avoid unnecessary purchases. This module enables you to make informed decisions that optimize your inventory investment and improve your bottom line.
- Enhanced Customer Satisfaction: With precise inventory control, you can fulfill customer orders promptly and accurately. Avoiding stockouts ensures that you can meet demand consistently, enhancing customer satisfaction and loyalty. The Inventory Management module helps you deliver a seamless customer experience by ensuring the availability of materials when needed.
Experience the power of the Inventory Management module and take control of your inventory with confidence. Say goodbye to manual tracking and inefficiencies, and embrace a streamlined approach that optimizes your inventory management processes, improves productivity, and drives business growth.
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.
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.
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.
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.
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.
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.
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