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?
Process safety
The workflow system ensures that the CAPA is forwarded to the respective subject matter expert after each step. The escalation system takes effect in case of missed deadlines.
Data integrity
Corrective And Preventive Actions (CAPAs) are no longer lost because they are digitally stored from the beginning. You also protect your data from unwanted actions of unauthorized users and from destructive forces.
Constant availability
Access your data at any time. It does not matter where you are.
Reports
Create reports and statistics about your CAPAs.
Traceability
CAPAs can be linked to other modules such as Change Control. This creates a traceable chain of interrelated individual processes. CAPAs can be initiated, for example, from deviation reports or initiate a change process.
Transparency
Every authorized employee sees the current status of all CAPA processes — even if he or she is not involved in the process.
Central information platform
Use the d.3ecm system as your central information platform on which you can retrieve all your data at short notice.
Individual configuration
Let the modules be configured according to your wishes and preferences to flatten the learning curve for your colleagues.
Features of the Corrective and Preventive Action software
- Automatic classification of the deviation based on the metadata entered in the form
- Referencing master data from your ERP system
- Integrated absence management
- Initiation of the individual tasks for the further processing of the workflow
- Attach documents, such as digital photos to your CAPA form
- Initiation of a document change request for a controlled document
- Escalation messages both within the system and by e‑mail
- Automatic PDF creation and storage of the form in the eDMS after each step
Regulatory requirements for the CAPA process
- ISO 9001:2015, Chapter 8
- ISO 13485:2016, Chapter 8
- EU-GMP Guideline Part 1, Chapter 8
Would you like a live webcast of the software?
Get a live insight into the possibilities of the production-related QM processes in just 45 minutes with a sample use case. Learn how you can use the solutions of d.velop Life Sciences to optimize your production-related QM processes such as complaints (Complaints), deviation reports (Deviation Control), Corrective And Preventive Actions (CAPA) or change controls (Change Control) with our digital workflows
33 Good reasons for a cooperation with d.velop LS
You’re not convinced yet? Find out about 33 good reasons speaking for a cooperation with d.velop Life Sciences GmbH. We will show you reasons from the provider’s point of view, from the software point of view and other general reasons that distinguish us.
Frequently asked questions (FAQs) about CAPA
Are there time limits for the processing of the process steps?
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.
Can attachments be stored with a CAPA?
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.
Can a process be cancelled?
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.
Are there templates for measures in a CAPA?
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.
Can process steps be subsequently corrected?
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.
Can tasks be delegated?
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.
Can I analyze the CAPAs?
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.
Can the predefined steps be customized?
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.
Can the predefined designations be changed?
In the workflow administration, you can configure the names of the process steps, field names and datasets.
Are the contents of all process steps visible?
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.
Document Control
Whether work / process instructions (SOPs), process descriptions, test specifications or other types of documents — you can create, revise and sign them all digitally with this module.
Training Management
Extend the “Document Control” module to actively plan and record the qualifications of your employees with our training management.
E‑learning
Use the new module “E‑Learning” to train your employees digitally. Create an e‑learning course according to your wishes using Microsoft PowerPoint or integrate existing presentations.
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