Regulatory
Management System
Welcome to Cloudtheapp’s innovative Regulatory Management System (RMS) Solution, where we transform the way organizations navigate the intricate world of regulatory compliance. At Cloudtheapp, we recognize the paramount importance of effective regulatory management in today’s ever-evolving business landscape.
Our RMS Solution is all about adaptability and real-time insights. We provide unmatched flexibility, allowing you to customize our solution to precisely align with your organization’s unique regulatory needs. Simultaneously, our real-time analytics empower you to make informed, data-driven decisions, enhancing regulatory compliance, risk management, and operational efficiency.
Explore our comprehensive Regulatory Management System, featuring a suite of specialized modules tailored for regulatory professionals. Take the first step towards revolutionizing your approach to regulatory compliance. Join us on a journey to master the challenges of regulatory management in today’s rapidly changing business environment.
Comply with Regulations and Standards
Request your demo today
RMS Modules
Regulatory Dossiers and Submissions
Regulatory Dossiers and Submissions Module is designed to revolutionize the way businesses manage their regulatory compliance processes. This cutting-edge module allows organizations in industries such as pharmaceuticals and medical devices to seamlessly digitize their regulatory documentation, ensuring compliance with regulations and simplifying the submission process to regulatory agencies worldwide. With Cloudtheapp’s powerful platform and integrated solutions, businesses can effortlessly create and track regulatory dossiers, leveraging real-time analytics to gain valuable insights and optimize their regulatory strategies. Experience the power of streamlined regulatory processes and enhanced compliance with Cloudtheapp’s Regulatory Dossiers and Submissions Module.
key features
- Digitalization of Regulatory Processes: The module enables businesses to digitalize their regulatory processes by creating dossiers of documents to comply with regulations and tracking submissions to regulatory agencies.
- Seamless Integration: The module seamlessly blends with other modules in the Regulatory Information Management (RIM) and Quality Management System (QMS) solutions provided by Cloudtheapp.
- Industry Applications: The module is beneficial for organizations in industries such as pharmaceuticals, medical devices, and others that require regulatory compliance. It supports the creation of dossiers for various purposes, including Common Technical Documents (eCTD) for New Drug Applications (NDA) and 510(k) Premarket Notifications for medical devices.
- Streamlined Process: The module streamlines the regulatory dossier creation process, making it easier to handle and track initial submissions and amendments to regulatory agencies like FDA, EDQM, and MHLW across different countries.
- Simplified, Systematized, and Digitalized Processes: Cloudtheapp aims to simplify, systematize, and digitalize the processes involved in introducing new drugs and medical devices to the market using their renovated module.
- Template-Based Approach: The module allows users to define templates for regulatory dossiers, specifying modules and sections as instructed by regulatory bodies. These templates can then be used to create live dossiers that link to relevant documents.
- Real-time Analytics: The module generates valuable data throughout the regulatory dossier and submission activities. Cloudtheapp offers integrated real-time analytics, enabling organizations to visually analyze the data, identify trends and patterns, and draw important conclusions to enhance their regulatory processes.
- Configurable: With the power of the Cloudtheapp Platform, businesses can tailor the design of the module and other integrated solutions to fit their specific needs without requiring coding or dealing with unfamiliar technologies.
key Benefits
- Enhanced Efficiency: The module streamlines the regulatory process, enabling businesses to create and manage regulatory dossiers more efficiently. It automates document creation, linking, and tracking, reducing manual effort and minimizing errors. This efficiency translates into time and cost savings for organizations.
- Improved Compliance: By digitizing regulatory processes, the module ensures better compliance with regulations and guidelines. It helps organizations stay up to date with regulatory requirements, track submission deadlines, and manage amendments effectively. This proactive approach to compliance reduces the risk of penalties, non-compliance issues, and delays in getting products to market.
- Streamlined Collaboration: The module facilitates collaboration among different stakeholders involved in regulatory activities. It provides a centralized platform for teams to work together, share documents, and maintain version control. This collaborative approach promotes cross-functional communication, leading to better coordination and faster decision-making.
- Real-time Analytics and Insights: Cloudtheapp’s integrated real-time analytics feature allows businesses to gain valuable insights from their regulatory data. By visualizing trends, patterns, and performance metrics, organizations can identify areas for improvement, make data-driven decisions, and enhance their regulatory strategies. These insights also contribute to continuous process improvement and better decision-making at all levels.
- Tailored Configurability: Cloudtheapp’s platform offers businesses the flexibility to tailor the module and other integrated solutions to their specific needs without the need for coding or complex customization. This configurability empowers organizations to adapt the software to their unique regulatory requirements, ensuring a seamless fit within their existing processes.
Overall, the Regulatory Dossiers and Submissions Module provides businesses with increased efficiency, improved compliance, streamlined collaboration, valuable analytics, and configurability. These benefits enable organizations to navigate the complex regulatory landscape with ease, maintain compliance, and optimize their regulatory strategies for successful product approvals and market access.
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.
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.
Enterprise Risk Management
Roll out a business strategy that aims to identify, assess, and prepare for any dangers, hazards, and other potentials for disasters that may impact your organization’s operations and goals.
Similarly, identify opportunities and assess them, and maximize benefits by putting plans to address positive risks.
Introduce plans of actions, and make them accessible to all stakeholders. Ensure all risks and opportunities are under control while running the business successfully exceeding customers and stakeholders’ expectations.
key features
- Define strategic objectives and business plans.
- Identify various risks and opportunities, and map them to objectives.
- Classify risks and opportunities for better management:
o Operational
o Financial
o Strategic
o Compliance
o Hazard - Perform risk assessment using quantitative and qualitative approaches.
- Assess probability, severity and impact. Automatically calculate risk level using risk assessment two dimensional matrix or three dimensional cube.
- Setup and define risk responses of different types:
o Mitigate
o Avoid
o Accept
o Enhance
o Remove - Define plan of actions for each risk response, defining what needs to be done immediately, and what needs to be done based on a risk trigger. Have the different actions assigned to the team to ensure parallel processing with full collaboration.
- Setup controls with drills and tests to ensure your risks and opportunities are controlled by a solid process in place.
- Reassess your risks to ensure they are mitigated to acceptable levels.
- Ensure all risks are in a controlled state and run. Iteratively identify new risks based on changing business climate and address them.
- Fully compliant electronic signatures to capture approvals.
- Compliant audit trail to track changes up to the field level, with traceability on files.
- Configurable workflows and forms using leading edge No-Code designers.
- Built-in and integrated real time analytics solution that allows creating visualizations and dashboards.
- Cloud based and SaaS (Fully managed), which eliminates the need to deploy internal IT infrastructure, reduces your cost, and saves your time and effort.
- Implementation and data migration services to transfer your data from paper-based or other electronic systems.
Risk Assessments
Risk based thinking is crucial for everyday business decisions. It ensures being proactive instead of reactive when decisions are made.
Risk based approach must be followed in managing quality to ensure effectiveness of your Quality Management System. It ensures negative risks as well as positive opportunities are addressed.
Use this module to launch risk assessment from any process, and rely on the system to calculate the risk level for you based on predefined configurable matrices.
key features
- Launch risk assessment records from other processes like Quality Issues, CAPAs, Nonconforming Materials, Change Management and others.
- Calculate risk in a quantitative way and based on a predefined and configurable risk matrix.
- Fill risk dimensions like Probability (likelihood) and Severity, and let the system calculate risk level for you.
- Document qualitative information about the risk like risk assessment and impact assessment description.
- Attach files and photos to clarify risk and impact.
- Design and configure 2-dimensional risk templates (e.g., based on Probability and Severity).
- Design and configure 3-dimensional risk templates (e.g., based on Probability, Severity and Consequence)
- Make the right decision by following risk-based approach in Quality Processes. Your risk assessment is fully integrated in processes with full visibility on calculated risk level.
- Fully compliant electronic signatures to capture approvals.
- Compliant audit trail to track changes up to the field level, with traceability on files.
- Configurable workflows and forms using leading edge No-Code designers.
- Built-in and integrated real time analytics solution that allows creating visualizations and dashboards.
- Cloud based and SaaS (Fully managed), which eliminates the need to deploy internal IT infrastructure, reduces your cost, and saves your time and effort.
- Implementation and data migration services to transfer your data from paper-based or other electronic systems.
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.
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.
recent posted blog
Hazard Horizons: Introducing Cloudtheapp’s Hazard Analysis Module
The Hazard Analysis Module is designed to empower organizations by providing a systematic and efficient approach to identifying, assessing, and mitigating hazards across various aspects of their operations. Whether it’s analyzing hazards related to specific job functions, processes, chemical handling, or storage, this module offers a comprehensive solution.
Empowering Environmental Health and Safety: Cloudtheapp’s Chemical Management Module Unveiled
Our Chemical Management Module offers a robust platform for comprehensive chemical information management. Access detailed chemical profiles, including properties, hazards, handling procedures, and storage requirements. Empower your team with the knowledge required to ensure safe and responsible chemical usage.
Transforming Quality Control: Introducing the Advanced Inspections Module
Cloudtheapp Inc. proudly introduces the groundbreaking Advanced Inspections Module. This latest addition to our suite of tools revolutionizes quality control, empowering organizations to streamline inspections, make informed decisions, and ensure product excellence.
