Quality Management System for Medical Devices Manufacturers

The Documents entity was rethought, becoming more flexible. Now, Document Types and access permissions settings cover the management of Suppliers, Purchase Orders, Equipment, Actions, Validation Process, and other artifacts. The number of Types is not limited. The Filter allows users to select documents quickly.

RBAC permissions give users the ability to view or edit Documents according to their permissions. This approach enhances the Security Controls, ensures data confidentiality, and allows managing actions with data/documents and their revisions transparently. RBAC permissions are granted by an Admin via User Group settings.

The Revision field allows the user to classify the revision number keeping the correct versioning. The combination of Type, Name, and Revision of any Document is unique within the Organization. Users can create, edit, delete Revisions, set specific Revisions as Final, depending on access level.

Actions allow the Organization to track tasks. Besides the tasks management with tracking assignees, assigners, and tasks’ statuses, the system logic will enable users to automatically create tasks of certain kinds that facilitate the general quality management processes within Organizations.

Actions are automatically created when Document Revision requiring Training is approved, User is added as a Document Reviewer/Approver, selected as the Document Responsible, or assigned a Training. Actions can also be created manually on the “Actions” screen via the “Add New” button (depending on the access permissions).

An Action Status for automatically created Actions changes from “To Do” to “Complete” when the user completes the required task. Actions can be linked to any artifact: document revision, training, or HR record.

Training Records allow the Organization to track training records for Users. The Training Assignee (required field) can be any Admin, User, or an entire User Group. When a User passes the training, the Completion Progress training section reflects it. Users who have not completed the training are listed under “Pending.”

The Dashboard provides users with easy access to assigned artifacts, counters, and quick-actions buttons. It helps speed up navigation and document flow and improve user experience regardless of a role.

HR Records allow an Organization to store human resources data. They can be viewed and edited only by Admin. HR Records automatically appear when a new Admin or User is added to Organization. Admins can add Tags and attach files to the record. Users can find reference links to HR records that are available to them.

Tags with Global Search compose a user-friendly solution for tying up various artifacts within an Organization. Tags serve to label items and link similar artifacts, can be added to any artifact, and managed on the Organization Settings level by Admins and Users with permission. The Global Search helps identify artifacts with a particular Tag.

The Logs record all changes with data in the QSuite. In case of any inconvenience, the Super Admin can export the logs in CSV for all or selected Organizations. This approach creates additional value by increasing the reporting transparency and avoiding risks of contention.

The flexible logic of Logs Export allows users not only to export data for all/selected Organizations but also set the data parameters with advanced filters. Thanks to it, each Organization can receive data on specific requests.

Export of all the artifacts is also allowed in the system. This feature is flexible and sensitive to the current filters & search applied on the screen. Lists of artifacts export is carried out through CSV files. In addition, both list and detailed individual information for 1 item can be obtained via PDF format.