CAPA process for continuous improvement

CAPA Management – Everything Under Control

Combine actions, risk analyses, and quality processes into a comprehensive system. With PeakAvenue's CAPA system, you can analyze quality information, solve problems, and manage actions effectively, purposefully, and on time - for stable processes and consistently high quality.

Challenge

No CAPA means missing out on the opportunity for optimization

Without a professional CAPA system, optimization potential remains untapped. Only consistent CAPA application meets the requirements of various guidelines (ISO 13485, ISO 14971, ISO 9001, ICH Q10, GMP, etc.) and enables you to optimize your product and process quality.

Lack of control loop logic: Corrective and preventive measures are not consistently linked to product and process changes and deviation analyses.
Non-transparent processes: Those involved find it difficult to locate information – processes remain opaque and prone to errors.
Missed updates: Documents, procedures, and process descriptions are not consistently improved.
High documentation effort: Forms, lists of measures, and lessons learned must be maintained, tracked, and filed manually.
No individual customization: Predefined workflows often do not fit internal processes and must be laboriously adapted.
Lack of data integration: Methods such as FMEA, specification or requirements analyses often run in isolation – valuable synergies remain untapped.

Without an intelligent CAPA management tool, you risk inconsistent processes, compliance violations, and rising quality costs.

Solution

The right CAPA system consistently supports your improvement process

Our CAPA Management Tool brings structure, transparency, and traceability to your corrective and preventive actions - fully integrated into your procedures and processes. Companies in all industries benefit from a consistent CAPA process.

End-to-end control loop: Seamlessly link product and process changes and deviation analyses through CAPA actions – including monitoring and traceability.
Flexible input masks: Define different CAPA methods and required information for the context of CAPA actions.
Integrated quality methods: Use a detailed root cause analysis with Ishikawa and 5Why to define CAPA actions.
Comprehensive documentation: Progress, results, and proof of effectiveness are always available and up to date.
Central transparency: All participants have access to CAPA-relevant information – up to date, traceable, and version-secure.
Customizable workflows: Tailor the CAPA process to your company structure and requirements.

With the right solution, you can design your CAPA management to be process-oriented, audit-proof, and compliant with EU MDR/IVDR, FDA 21 CFR, ISO 13485, ISO 14971, ISO 9001, EU GMP, and ICH Q10.

A woman working on an 8D on the computer

Benefits

Key features at a glance

Integrated CAPA workflow

The process-oriented workflow connects all phases - from immediate action to prevention - with responsible parties, deadlines, and documentation.

Customized entry forms

Create company-specific CAPA method forms with individually configurable fields, mandatory fields, and workflows.

Direct traceability

You can track all changes, actions, and results seamlessly using the CAPA transaction number and integrated references.

Actions within the scope 

Use the link to FMEA, problem-solving, audit, and change processes to implement targeted improvements.

Central data access

Relevant information, tasks with processing status, timelines, and documents are available to all parties involved centrally and in real time.

Customized output reports

Create reports from the CAPA system, based on templates or as customized reports.

Our Brands

Quality at the highest level

The PeakAvenue platform combines the strengths of leading expert systems from APIS IT, PLATO, iqs Software, Isograph, and OSSENO Software into an integrated solution for end-to-end engineering and quality management.

Our current software solutions will remain available and will be supported in the long term, while future innovations will be incorporated into the PeakAvenue platform—ensuring a secure, step-by-step transition to a modern, networked software world.

PeakAvenue Plattform

Expert solutions united in one eQMS

The central basis for the quality and development of your products: Seamlessly connect tools, data, and processes for maximum transparency and efficiency throughout the entire product lifecycle.

Quality Center

End-to-end QMS software for long-term quality excellence

Achieve measurable, transparent quality improvements: iqs QC covers the complete quality control cycle - from planning and shop-floor inspection to in-depth analysis.

e1ns Engineering

Optimize product development and quality

Secure product quality from the very beginning: With PLATO e1ns, you manage your development process efficiently and reduce risks—web-based, structured, and fully integrated.

IQ Software

Your benchmark for FMEA and Risk Analysis

Achieve top-tier FMEA and risk analysis: APIS IQ-Software enhances your process efficiency and ensures lasting functional safety and quality.

Isograph RAMS

Expert software for RAMS and Fault Tree Analysis

Master complexity in reliability, safety, and availability: Isograph’s advanced tools empower companies to accurately evaluate and optimize complex systems.

reqSuite® rm

Efficient, intelligent requirements management

Streamline your requirements management - simpler, more structured, and more efficient: reqSuite^®rm from OSSENO Software delivers a top-tier solution that is intuitive, powerful, and enhanced with smart assistance.

Automate CAPA. Ensure compliance.

Choose CAPA software that creates transparency, makes risks manageable, and fully complies with the highest regulatory and normative requirements, including EU MDR/IVDR, FDA 21 CFR, ISO 13485, ISO 14971, ISO 9001, EU GMP, and ICH Q10.

CAPA Management – Everything Under Control

No CAPA means missing out on the opportunity for optimization

The right CAPA system consistently supports your improvement process

Key features at a glance

Integrated CAPA workflow

Customized entry forms

Direct traceability

Actions within the scope

Central data access

Customized output reports

Quality at the highest level

PeakAvenue Plattform

Quality Center

e1ns Engineering

IQ Software

Isograph RAMS

reqSuite® rm

Automate CAPA. Ensure compliance.

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Actions within the scope 