CAPA software
»CAPA Management — Corrective And Preventive Actions«
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
After each step, the workflow system ensures that the CAPA is forwarded to the person in charge. The escalation system takes effect in case of missed deadlines.
Data integrity
Corrective and preventive actions (CAPAs) are no longer lost because they are stored digitally from the beginning. You also protect your data from unwanted interference 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. Thus a traceable chain of interrelated individual processes is created. CAPAs can be initiated, for example, from deviation reports or can 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 on short notice.
Individual configuration
Let the modules be configured according to your wishes and preferences to facilitate the onboarding training of your colleagues.
Features of the Corrective And Preventive Actions 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
- Adding 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 in the CAPA process
- ISO 9001:2015, Chapter 8
- ISO 13485:2016, Chapter 8
- EU GMP Guide Part 1, Chapter 8
Get a first overview
The digital forms are also converted to a PDF/A in parallel. This way, employees who are not involved in the process can also gain insight into the workflow and the document can be shared with external parties if required.
What is a CAPA process?
The CAPA process (Corrective and Preventive Action) allows drug safety errors/deviations to be systematically recorded and processed in conformity with regulatory and internal specifications. In the process, CAPA management focuses on the elimination of nonconformities (corrective action) and the avoidance of potential nonconformities (preventive action). Nonconformities follow, for example, from a process deviation that results in certain corrective actions that can eliminate the existing problem. For example, a preventive measure could result from an OOT analysis. No actual nonconformity has occurred here yet, but a degradation of the validated process has been noted. The CAPA process can thus ensure continuous product quality.
Every action in the process is automatically documented by the system accordingly. Integrated audit trail functions ensure high traceability.
The digital form is filled out step by step and provided with the relevant entries and data. Fields with a blue background are mandatory. Predefined value sets and drop-down functions make it easy for users to fill out the form.
After processing the individual steps (1. Initiation, 2. Recording of measures and risks, 3. Expert committee, etc.), the workflow system automatically sends tasks and messages to the responsible agents or workflow participants. Once all steps have been processed, the workflow is considered complete.
1st Step: Initiation
The initiation of the CAPA is done by the process responsible of the concerned department. He or she records the relevant data for CAPA. The process is then forwarded to the appointed CAPA responsible.
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 (Complaint), 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 are 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 as well as other general reasons that distinguish us.
Frequently asked questions (FAQs) about CAPA
Are there time limits for the execution of the process steps?
Can attachments be stored with a CAPA?
Can a process be cancelled?
Are there templates for measures in a CAPA?
Can process steps be subsequently corrected?
Can tasks be delegated?
Can I analyze the CAPAs?
Can the predefined steps be customized?
Can the predefined designations be changed?
Are the contents of all process steps visible?
Customer review on the CAPA Management
“With the project staff of d.velop Life Sciences a rapid implementation of the new DMS was possible in only three months. The modular structure of the system additionally allows a coordinated step-by-step range extension. The software was quickly accepted by all employees due to its clear design, which not only simplified the processes and release cycles in a very short time, but also improved their quality.”
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The CAPA 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.
Quick contact
Our sales team will help you promptly and gladly.