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CAPA Software

Initiate CAPA processes, identify root causes, and seamlessly verify effectiveness.
Software CAQ.Net
Analyze root causes systematically
with 5 Whys & Ishikawa
Transparency & traceability
through action management
Avoid redundancy
with integrated data

CAPA-Software
CAPA-Assistant in the CAQ.Net Software

Structured CAPA Management Instead of Confusing Spreadsheets

The CAPA concept (Corrective and Preventive Actions) required by GMP, ISO, and FDA regulations such as ISO 13485 and FDA 21 CFR 820 is a central element of quality management in medical technology. When documenting incoming goods, quality inspections, or complaints manually or in separate spreadsheets, essential requirements such as information transparency, data compatibility, and consistent traceability are not fulfilled. Without structured root cause analysis, clear responsibilities, and automated action tracking, no effective CAPA and PDCA process can be established.

This is exactly where CAQ.Net comes in: As integrated CAPA Software, it links all quality-related data, supports methodologies such as 5-Why or Ishikawa, and ensures audit and compliance conformity – for efficient, sustainable, and fully documented error management.

Optimized CAPA Processes Thanks to Software

CAQ.Net bundles all quality-related data in a single system, enabling consistent, well-founded root cause analysis across the entire product lifecycle. Whether its incoming materials, production, or employee training, the actual root cause can be identified centrally and transparently. Since the reason for triggering a CAPA can arise in many areas, the CAPA process in CAQ.Net is not implemented as a single module, but is integrated as an assistant-supported, cross-module function. This allows you to start a CAPA directly where it arises and carry it out efficiently in just a few steps – for example, in calibration management, employee training management, audit management, or complaint processing.

With a cross-departmental software solution such as CAQ.Net, you can not only execute CAPAs effectively, but also have a globally applicable tool with which you can monitor, control, and document your entire quality management system.

Avoiding CAPAs through continuous improvement

CAQ.Net is a globally applicable tool that allows you to monitor, control, and document your entire quality management system. This enables you to eliminate the reasons for a possible CAPA as far as possible before the product development process begins. After all, the CAPA process as defined by the FDA is the last resort in quality management and should not be initiated excessively.

CAPA Software FAQ

Which key functions does CAPA software such as CAQ.Net offer?

CAPA Software such as CAQ.Net enables the centralized recording and analysis of deviations, supports structured root cause analysis, controls actions and effectiveness checks, integrates all quality-related data, and fulfills audit and compliance requirements, GMP, ISO, and FDA requirements – such as from ISO 13485 or FDA 21 CFR 820 – and ensures a consistent, efficient PDCA process through transparent evaluations.

Can I initiate CAPAs directly from complaints or deviations?

Yes, in CAQ.Net you can initiate CAPAs directly from complaints or deviations. If an internal deviation process requires a system CAPA, you can create the CAPA process directly from it. All relevant information, such as order data and complaint text, is automatically transferred to the CAPA tab, allowing you to continue the process without having to enter the data twice.

How does the software ensure that actions are implemented on time?

CAQ.Net ensures that actions are implemented on schedule through automated task & escalation management. Responsible parties receive the relevant actions with fixed deadlines, and the system automatically reminds them of upcoming or overdue tasks and actions. This ensures that every action remains transparent, traceable, and can be controlled on schedule.

How does the software support the effectiveness monitoring of CAPA actions?

CAQ.Net supports the effectiveness monitoring of corrective and preventive actions by offering the option to check the effectiveness of actions after they have been implemented, mark them as “effective” using a corresponding indicator, and – depending on the system settings – automatically lock them or release them for further processing, thereby ensuring a traceable and documented evaluation of the effectiveness of the actions.

How does CAQ.Net help prevent recurring errors in the long term?

CAQ.Net helps prevent recurring errors in the long term by systematically analyzing the causes of errors, recording appropriate CAPA actions, and specifically monitoring their implementation and effectiveness.

Why CAQ AG?

Service Commitment and Product Philosophy

Our understanding of service is based on supporting our customers in each and every aspect relating to our software solutions. With our maintenance contract, we offer a complete package that includes everything you need to ensure continuous support for your CAQ.Net software solution before, during, and after implementation.
  • Included
    Updates, Upgrades & Release Changes
  • Included
    Support from QM & IT Professionals
  • Included
    User Workshops
  • Included
    Screencasts
  • Included
    Conformity to Standards
  • Included
    Information Security
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Fully Configurable
Packaged Software