CAPA management software for secure SQM management

Digital corrective and preventive action with CAPA software

Corrective and Preventive Actions (CAPAs) are an important part of quality management. Often this means: a lot of paper, little overview. CAPA management software can help.

Manage CAPAs digitally

Automated workflows

Reliable processing

Secure documentation

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Successful CAPA management with workflows

CAPA processing builds on events such as deviations and audit results. A lot of information has to be processed, and numerous parties are involved. In addition, the documentation of activities and events must meet high standards. Why? On the one hand, it is important to be able to refer to the past. On the other hand, individual CAPAs must be documented in accordance with the rules. It’s complicated.

Say goodbye to bulging folders and the search for documents. It's easier digitally: with CAPA management software for corrective and preventive actions.

Uncomplicated management of CAPAs with digital workflows, even across modules

Completely digital processing is possible - from capture to completion

Attach information and documents to the respective work step

Information and documents are available to stakeholders, even after CAPA completion

Automatic forwarding of information and activities to the next instance

 

Timeouts are reported by the reminder and escalation management

The solution includes a fully integrated substitute provision

The solution is an optimal addition to the Deviation Control module

The 8 biggest benefits of CAPA management software

CAPA management software

This - and much more - awaits you:

  • Deviations are automatically classified based on stored metadata
  • Master data in your ERP system is referenced
  • Use the option to designate a substitute
  • Initiate individual tasks to continue work on your processes
  • PDF creation and form storage in your eDMS after each step
  • Receive escalation notifications directly in the system or via email

with partnerships

YAVEON relies on the QM solutions of our partner d.velop Life Sciences

Consulting expertise meets proven features: YAVEON and d.velop Life Sciences - the perfect combination. YAVEON has years of experience and expertise in the regulated environment and serves numerous clients in the pharmaceutical and medical technology industries. The d.velop Life Science modules are precisely aligned to the needs of customers from the regulated environment and provide a solid foundation. The combination of professional consulting and smooth-running products is unbeatable. Take a closer look.

Logo d.velop Life Sciences

These regulatory requirements are met with CAPA management software

  • ISO 9001:2015, Chapter 8
  • ISO 13485:2016, Chapter 8
  • EU-GMP Guideline Part 1, Chapter 8
Fulfilled regulations of CAPA management software

Curious to learn more?

YAVEON QM modules - partner solutions of d.velop life sciences

In our YAVEON QM modules factsheet, you will learn

  • how to organize controlled documents,
  • how to respond if something goes wrong,
  • how to plan and record qualifications of your employees
  • how to integrate modules and systems,
  • how to train your employees,
  • how to create a CAPA and access it repeatedly,
  • and much more.
Preview Factsheet Digital Quality Management

Questions are there to be answered.

The most important FAQs around CAPA software

Is it possible to file documents in CAPA?

It is possible to upload and link additional assets in the process steps. The filing takes place in the DMS. In CAPA Management, these can be viewed by all stakeholders.

Can time specifications be assigned for the handling of process steps in CAPA?

Yes, in the CAPA software, time specifications can be defined for each process step.

Are there templates for measures in a CAPA?

If required, you can save a measure entered in the CAPA Management System as a template. 

Can process steps in CAPA be corrected retrospectively?

An electronic signature generally completes the process steps in CAPA. However, it is possible to send the process back one step and thus process the previous step again. Such measures are documented in the audit trail.

Are the contents of my CAPA process steps visible?

If you are in a process step, you can generally edit it. You can see all other steps in CAPA simultaneously at any time.

Can CAPA tasks be delegated?

Yes, you can forward the process steps to a colleague in the CAPA system. The system checks whether the user has the necessary permissions.

Can CAPAs be evaluated?

All essential data is transferred directly to the dataset attributes. This makes it possible to perform a search and create evaluations. These evaluations can then be exported as PDF, Word, or Excel.

Is it possible to change the defined steps in the CAPA module?

The CAPA process flow is unified with the GxP regulations and developed in close cooperation with QM experts - the steps are pre-defined. "Custom Panels", however, allow you to display more info and trigger actions. 

Is it possible to change the designations used in the CAPA module?

Yes. You can configure the designation of the process steps, field designations, and value sets directly in the workflow administration.

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