Improve processes in the medical and pharmaceutical sector with SmartProcess!
SmartProcess supports you in the representation of processes, the management of documents and qualifications, and the control of CAPA measures as a workflow.
Modeling and visualizing processes with the BPMN notation
Publish SOPs and documents with an approval workflow
Process and evaluate CAPA actions as a workflow
Identify training needs and plan training
In 21 CFR Part 11, the FDA defines requirements for the use of electronic records. In particular, requirements are also made here for the traceability of changes and for electronic signatures. An audit trail is available for the traceability of changes. And in SmartProcess, it can be set that the password is entered before each electronic signature. We would be happy to send you a white paper on how SmartProcess covers 21 CFR Part 11.
You can display the main processes in the GxP software and easily assign processes. The process maps provide users with a transparent overview of all processes. Via process maps you can optimally recognize interactions between processes. SmartProcess supports you comfortably in the GxP software in the representation of main processes.
With the process management functions you model processes in the GxP software and SOP software. The process descriptions support you, for example, with the GxP requirements and with the coverage of ISO 13485. In SmartProcess, modeling is done according to the BPMN notation, which offers a transparent overview of processes and responsibilities with the swimlane representation. SmartProcess offers you user-friendly and consistent modeling that provides you with many opportunities to improve your processes.
You check and publish the processes via an approval workflow. The processes are versioned throughout. As GxP software, SmartProcess offers numerous functions for process management and quality management.
The documents are released and versioned in SmartProcess in a controlled manner. This allows you to easily create Standard Operating Procedures (SOPs) and publish them with an approval workflow. As GxP software and SOP software, SmartProcess offers you many document management functions. Documents are uniquely assigned an automatically assigned number. The validity is also controlled automatically. You can edit documents directly via Check In / Check Out. Conveniently manage and publish documents audit-proof with SmartProcess.
CAPA actions (Corrective Actions, Preventive Actions) are used to investigate deviations and initiate actions. The goal is to avoid new deviations and improve processes with corrective and preventive actions. Especially in the areas of medical technology and pharmaceuticals, you can use SmartProcess to record and control CAPA actions as a workflow. You can use the workflow designer in the GxP software to flexibly define the input masks and the processing sequence.
With the GxP software and SOP software SmartProcess for medical technology and pharmaceuticals, you can also automate the processing of procedures, forms and approvals. Input masks and processes can be defined flexibly. Open processes and tasks are displayed transparently in a task list. With the workflow functions, you can enter a lot of data electronically and process it as a workflow.
You can easily identify training needs with the GxP software SmartProcess. An employee’s qualifications and credentials are displayed in a qualification profile. The qualification matrix provides a transparent overview of all qualifications. You can plan training and transfer acquired qualifications from the training into the employee’s qualification profile. SmartProcess offers you end-to-end qualification and training management in the medical technology and pharmaceutical industries.
When processes or SOPs (Standard Operating Procedures) are published, they can automatically appear as target qualifications in the employee profile, where they can be confirmed. Furthermore, a training or reading confirmation is automatically requested from the employee when a publication is made. This ensures that employees are briefed and trained for new revisions.
Get to know SmartProcess – without obligation and free of charge
