QMS (QMStorm)
QUALITY MANAGEMENT SYSTEM
The application allows effective documentation management in a way that supports the processes of quality management system. Documents such as: Quality Manual, General Procedures, Standard Operating Procedures, Manuals alongside with attached documentation are stored and processed in the system. The processes of creating, reviewing and approving changes in the quality system are supported in the application, thus eliminating the need for paper documents storing entirely. As part of the support of quality management system it is also possible to document corrective and preventive actions, potential for improvement, risk management as well as planning and conducting audits. The application enables integration with external systems such as laboratory management systems or production systems. As a result, we are able to supervise the functioning of all aspects of the quality management system in our organization in a clear and transparent way.
Reliability
Constant access to up-to-date documentation ensures the work is uninterrupted and enables the provision of services at the highest
level. The implementation of Document Management Application allows the storage of all documents as well as quick access for authorized users from any workstation.
The system allows to search or filter through gathered documents by content, title or using key words.
Tagging documents and grouping tags into categories makes it easier to explore and work with documents, which is especially important in organizations with an extensive structure.
Safety
The application allows granting permissions related to access and processing the documentation to both individual users as well as groups. Depending on users’ rights, documents may be read-only or editable. Auto saving of backup copies guarantees that the original data can be restored if it is damaged or lost due to hardware failure. Data integrity is ensured as part of the backup mechanism.
Configurability
The structure and types of documents in the system are created by the user who can also modify them, which allows to reflect any changes taking place in the organization and the processes. The workflows for adding or editing documents used in the system are adapted to the procedures followed in the organization. The modern and ergonomic user interface allows modifications
without the assistance of a programmer. Workflows allow the distribution of documents as well as assigning tasks to both individual users and groups.
The use of an electronic signature allows complete digitization of processes and elimination of paper documents.
Tasks and notificationse
Depending on the type of document, selected workflow and permissions granted in the system, users receive notifications about the tasks they need to performed, such as reviewing the document, approving it, creating a training plan or a document effective date plan. These notifications are visible in the system and can also be sent as email messages based on templates adapted to the organization.
Document history
Keeping a register of changes in documentation is necessary in organizations with an implemented quality management system. The Document Management Application allows the user to monitor changes introduced in documents alongside with their justification. All new versions of documents are saved in the application and uniquely identified.
The document history together with its archived versions are available for system reviews and audits. It is possible to create reports for user-selected date ranges.
Links and relations
Creating links between documents makes it easier to work and maintain control over documents in the management system. Documents related to each other are updated faster and more effectively, which minimizes the risk of omissions and mistakes.
Trainings
Application users receive notifications about new documents they need to familiarize themselves with as well as their due date. Depending on the type of document and its purpose, it is possible to assign training courses to both individual users and groups. Training materials are available in various forms: PDF document, video and audio podcast, etc.
Technology
The use of the latest technological solutions guarantees flexibility, configurability and scalability, enabling efficient and effective adaptation of the solution to the way of operation and the specificity of the user’s key processes, with the degree of their complexity depending on individual needs. The software can be delivered in the cloud or installed on the customer’s infrastructure, guaranteeing scalability, allowing the users to decide on resource consumption, depending on their needs. The use of the most cutting-edge solutions based on web technologies makes it possible to operate the system from many device such as PC, Tablet using any operating system (Windows, MacOS, Linux).
Quality
Application supports the standards and requirements of ISO 9001, ISO 17025, ISO 15189, ISO 13485, GLP and GMP.
Modules
QMStorm has dedicated modules that allow you to manage specific areas in Quality Management System. Each of the modules can function independently, they can also be selected in accordance with the needs of the organization and combined into a coherently operating structure.
Documents
The Documents module allows you to create, edit, manage and store and archive documentation necessary to support the QMS. Documents are stored securely, and the system gives you the ability to assign access to documents only to authorized users or groups. The documentation is stored and processed in a systematic and controlled manner, subjected to procedures, and each change in the document is reported. This makes it clear who has read the document and who has made changes to it. This module allows you to define your own documentational processes based on predefined steps in the system, without the involvement of programmers.
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Documents entered into the system can be marked with keywords as well as linked to other documents or assigned to users or groups. Advanced document search allows you to find a document by tag, category, title, content as well assigned user or date range.
Module functionality
- Storage of documentation in electronic form – in any format (jpg, pdf, doc, xsl)
- Configurable processes for adding and editing documents
- User-defined document structure
- Management of user permissions
- Personal task list
- Notifications and reminders – e.g. about the new version of the document, pending tasks (in the system and by e-mail)
- Audit of document version history (possibility to generate a report)
- The ability to add tags to documents
- Advanced search options (by name, number, content, tags and others document attributes). Ability to export search results
- Creating links and relationships between documents
- Reports
- Archiving outdated documents
- Automatic backup procedure
- Electronic signature
- Document security
Audits
The Audits module gives you the ability to quickly and efficiently create and plan audits. Thanks to the calendar function you can schedule audits and the system will automatically send proper reminders. The module allows you to manage auditor competences, create checklists, plan and schedule audits, create final report and plan corrective actions. Audits module can be integrated with CAPA module, which significantly increases its functionality.
Module functionality
- Planning and scheduling (creating annual and long-term plans)
- Managing the process from start to finish of the audit
- Preparing and initiating an audit (audit program, creating checklists)
- Creating checklist libraries
- Assigning a risk level
- CAPA integration
- Notifications and reminders
- Managing user permissions
- Audit report
- Electronic signature
- Data security
Processes
The module enables process management in accordance with the ISO 9001 standard. It consists of on systematized view of process cards with which you can associate procedures, roles, permissions and responsibilities. Indicators and measures can be assigned to each process card. Clear layout allows you to intuitively manage, monitor and analyze processes related non-compliances. The module can be linked to the Risk Management, Audits or Documents module.
Module functionality
- The ability to enter a process card
- Assigning a set of documents and procedures to a given process
- Periodic process reviews
- Introducing and evaluating indicators and metrics
- Notifications (e.g. about changes in the process, updates of documents assigned to the process)
Training
The module enables quick and effective creation of training for employees, both online and on-site. As part of the module, the user can send training materials in the form of text, audio, video or image files. The training can be assigned to a given one user or group of users, with a set start and end date.
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The module allows you to check the skills of training participants through tests, surveys, etc., as well as to track the training history and results of a given employee. Integration of Training module with other system, e.g. LIMS, production or HR systems provides a full picture of employee competences. As a result, it optimizes the process of assigning certain tasks to employees.
This way, the module can be used to determine whether an employee has permissions and skill, e.g. to work with a given device or to carry out tests based on a specific procedure.
Module functionality
- Training assignment
- Assignment of retraining – e.g. after CAPAModule functionalityssing, editing and viewing training)
- Assign training to any person or group of people
- Full history of changes (access to the full history of changes made by a given user in system, access to the full history of changes for the selected training)
- Reports
- Notifications and reminders (e.g. about new training, about the due date of the training)
- Reminders from the system administrator to users, e.g. about waiting training
- Electronic signature
CAPA
The CAPA module allows for transparent and effective management of corrective and preventive actions. Non-compliances can be reported directly by the system users (e.g. employees of the production hall), they can also be related to audits or introduced documentation (e.g. customer complaint). The module allows you to collect all data related to non-compliances in one place, which greatly facilitates their monitoring and analysis, as well as tracking what corrective and preventive actions have been applied, whether they have had any effect and what are the quality trends in the company, e.g. if the problem reoccurs.
Module functionality
- Managing user permissions (related to processing, editing and viewing of corrective and preventive actions)
- Assign non-compliance to any person or group
- Constant supervision over the CAPA processes
- Classification of nonconformities
- Process audit (possibility to generate reports)
- Advanced Search
- Reports
- Notifications and reminders
- Archiving outdated documents
- Automatic backup procedure
- Electronic signature
- Data security
Complaints
The Complaints module includes an external portal available on the website for receiving complaints from customers and an internal system for processing such notifications. It allows for a complete handling of complaints, from its registration through consideration, to taking final action. The module can be integrated with the CAPA Module, which enables an appropriate analysis of the causes of the problem, implementation of preventive actions, and as a result leads to the reduction of complaints of a similar nature in the future.
Module functionality
- Filing a complaint by any person (unlogged user)
- Reporting a complaint/order for research by a business client (logged in user)
- Access to the history of requests (logged in user)
- Processing requests in accordance with the established process
- Integration with CAPA
- Generating reports
- Access to historical reports/analyses
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