For seamless risk management

Optimize your risk management processes according to ISO 14971 and ICHQ9, establishing a seamless connection between product development, production, and downstream processes.

As part of post-market surveillance, gather and analyze information to detect current and potential product and quality deviations. An assessment leads to the decision of whether actions are required in case of non-conformity/deviation:

  • Immediate action
  • Correction
  • Corrective action
  • Preventive action

For implementation, leverage the e1ns complaint workflow. This involves utilizing the integrated e1ns.actions action management, as well as forms for incident documentation, incident description, incident analysis, action documentation, and documentation of results/lessons learned in coordination.

To support the root cause analysis for existing or potential non-conformities, the error list of the FMEA can be accessed, and errors can be selected.

An update of the risk analysis and assessment due to a non-conformity/deviation and derived corrective or preventive action can be traced back through the CAPA transaction number and a reference in the CAPA process.

Your benefits

Why e1ns CAPA?

Consistent, up-to-date, and readily available data

  • Through the e1ns portal, all stakeholders can quickly find and access the processes, information, changes, and result documents related to CAPA.
  • Proof documents/outputs are always up-to-date and available at the push of a button.

Consideration of individual requirements

  • e1ns CAPA benefits from the e1ns modular concept.
  • The CAPA workflow is configured in a process-oriented and customized manner for each company.
  • CAPA forms are supplemented with additional columns or data as needed, depending on the internal requirements of a company.

Information transparency and data compatibility

  • With e1ns, quality methods are interconnected. An update to the risk analysis due to non-conformity/deviation and corrective or preventive actions can be traced back through the CAPA process number and a reference to the CAPA transaction.
  • Requirement and specification analyses are also integrated into the data model, supporting the process of product/process improvements.


Discover all e1ns methods

Tailored methods set to your development process with the associated forms - simple, intuitive, in the web browser.

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Creation of FMEAs: Worldwide, easily and in a team.

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Inspection Plan

Quality assurance measurements during production.

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Process Flow

Process flows for identifying the causes of possible malfunctions.

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Change management with DRBFM: Success with methods.

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Functional Safety

Functional safety (ISO 26262) and FMEDA.

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Complaints & 8D

Permanent complaints resolution.

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Special characteristics

Ensure consistency of special characteristics.

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