Control your production-related QM processes such as Corrective And Preventive Actions (CAPA) with our digital workflows. Our integrated solutions manage your previously paper-bound process from capture to completion completely digitally. The workflow system automatically forwards the digital form to the next instance; if deadlines are exceeded, the reminder and escalation management takes effect. Of course, an absence management is also included for the task routing.
How can you benefit from the CAPA software?
Features of the Corrective and Preventive Action software
Regulatory requirements for the CAPA process
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Frequently asked questions (FAQs) about CAPA
In the administration, time specifications can be entered for each process step. Reminder messages are sent before the process steps are due. The reminder message is sent to the processor of the task, the coordinator and the configured group that is to be informed about the reminder (for example, QA). A reminder is sent with the configured subject.
If additional files are required for a process, attachments can be uploaded in all process steps and linked to the current process. The attachments are stored under a corresponding document type in the DMS and can be viewed in CAPA under ‘Attachments’ by all process participants. You can configure which file types can be saved as attachments and how large the files can be.
It can be configured so that the process can be cancelled at any process step. For the cancellation, it is required to indicate a reason in a mandatory field. Cancelling is only allowd for the coordinator of the process.
Having entered a measure, you can save it as a template in the measure table. The templates are available to be added to a CAPA. The due date for the measure is calculated based on the duration entered in the template.
In principle, a process step is completed with an electronic signature and can no longer be corrected. With the function ‘Step back’ the process can be returned to a previous process step. The user who has completed this step receives it again for editing and the process continues from this step. Any return to a previous step is recorded in the audit trail.
In all process steps that follow the initiation, you can forward the process step to another person. The authorization of the recipient is checked during selection.
The essential data of a CAPA is transferred to the attributes of the data record. You can use this to search and create an analysis of the CAPAs created. The analyses can be exported as PDF, EXCEL or WORD documents.
The process flow of the CAPA is structured according to the specifications of the GxP regulations and was created in coordination with QM experts. With referehnce to the validation documentation, the process steps are therefore mandatory. However, each process step contains a ‘Custom Panel’, which can be used to display further information or initiate actions.
In the workflow administration, you can configure the names of the process steps, field names and datasets.
When editing a process step, only this step can be edited, but the other process steps are visible.
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The CAPA solution is a component of the d.velop life sciences solution suite. Each product is powerful on its own, but when used together they are even better.
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