Laboratory
Management System
Welcome to Cloudtheapp’s Laboratory Management System (LMS) Solution, where we transform laboratory operations for the modern business landscape. At Cloudtheapp, we understand the pivotal role of effective laboratory management.
Our LMS Solution is characterized by its adaptability and real-time insights. We provide the flexibility necessary to tailor our solution precisely to your laboratory’s unique needs, ensuring seamless integration and optimization.
Explore our comprehensive Laboratory Management System, featuring a suite of specialized applications designed to streamline laboratory operations. Join us in enhancing precision, compliance, and efficiency, empowering your laboratory to excel in today’s dynamic business environment.
Empowering Labs, Elevating Excellence
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LMS Modules
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.
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.
Chemical Management Module
Welcome to Cloudtheapp’s Chemical Management Module, a cornerstone of our comprehensive EHS (Environmental Health & Safety) solution. In this page, we will explore the core features of our Chemical Management Module, shedding light on how it transforms the way businesses handle chemicals, ensuring safety, compliance, and efficiency at every step.
Effective chemical management is pivotal for the safety of your workforce, compliance with regulations, and the well-being of the environment. Cloudtheapp’s Chemical Management Module is your trusted partner in achieving these crucial goals.
key features
- Holistic Chemical Information Management: Our Chemical Management Module provides a robust platform for holistic chemical information management. Access detailed chemical profiles, including properties, hazards, handling procedures, and storage requirements. Equip your team with the knowledge required to ensure safe chemical usage.
- Chemical Life Cycle Management: Effortlessly manage the entire chemical life cycle, from acquisition to storage, usage, and final disposition. Our streamlined workflow ensures that essential actions, such as moving chemicals to storage, usage, or disposal, require the necessary approvals, ensuring safety and compliance at every stage.
- Material Quantity Tracking: The module offers advanced chemical inventory functionality for precise tracking of material quantities. Keep a meticulous record of chemicals received, utilized, remaining, and disposed of. Minimize waste, optimize resource allocation, and stay in control of your chemical inventory.
- Enhanced Safety Measures: Going beyond standard compliance, our module enforces extreme safety measures. It provides visual aids such as GHS Pictograms and Safety Data Sheets (SDS) documentation. Ensure that your team adheres to safe storage practices, proper handling protocols, and emergency response procedures, enhancing safety and compliance.
- Compliance Documentation: Say goodbye to tedious paperwork. Cloudtheapp’s Chemical Management Module automates compliance documentation. Easily generate reports, audit trails, and compliance records, keeping your organization audit-ready and in compliance with regulations.
- QR Codes: Generate unique QR Codes for each chemical inventory record, which can be affixed to the stored material for easy retrieval of the electronic inventory record related to it. Streamline material tracking and retrieval, enhancing efficiency and accuracy in chemical management.
- Integrated Data Analytics: Leverage the power of integrated data analytics within the module. Extract valuable insights from your chemical management data. Visualize trends, identify areas for improvement, and make informed decisions that enhance safety, compliance, and operational efficiency.
- Extreme Configurability: We understand that each organization is unique. Our module offers extreme configurability, allowing you to customize workflows, forms, and reporting to align perfectly with your organization’s specific needs. Whether you’re a small business or a large enterprise, our module adapts seamlessly to your requirements.
Business and Compliance Benefits
- Regulatory Compliance: Cloudtheapp’s Chemical Management Module seamlessly aligns with relevant industry standards and country-specific regulations, especially in the United States. Ensure full compliance and safeguard your organization from potential legal issues and fines.
- Heightened Workplace Safety: Enhanced safety measures, visual safety guidance, and comprehensive chemical profiles contribute to a safer working environment. Promote a culture of safety, reduce accidents, and protect the well-being of your employees.
- Efficiency and Cost Savings: Streamlined workflows and precise inventory management lead to increased operational efficiency. Minimize waste, optimize resource allocation, and reduce costs, contributing to significant savings.
- Environmental Responsibility: Responsible chemical usage and disposal are crucial for environmental sustainability. Our module empowers your organization to minimize its environmental footprint, promoting responsible environmental stewardship.
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.
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.
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.
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.
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.
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.
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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