CAPA Management

Product defects are not just annoying. In the medical technology industry, even the smallest faults can lead to devastating consequences. Here, health and life ultimately depend on flawless devices and instruments. As a result, ISO 13485, among other standards, as well as the law require continuous detection and elimination of all deviations and faults.

Successfully Improve Products and Processes

CAPA Management: Processing and documenting a CAPA process in the QM software BabtecQ
Processing and documenting a CAPA process in the QM software BabtecQ

CAPA (Corrective Actions, Preventive Actions) is a proven method used to systematically investigate these deviations. The goal is to avoid a recurrence by using corrective and preventive actions. Especially in the field of medical technology, CAPA Management has established itself as an effective and strategically useful instrument for improving quality.

Comply with Standards – Support Processes

The QM software BabtecQ offers you process-oriented support in realizing and mapping your CAPA process. As a result, the standards-compliant implementation of regulatory guidelines and directives, such as the already mentioned DIN EN ISO 13485 or FDA 21 CFR 820.100, is ensured.

The entire CAPA process is mapped out transparently and in a standardized way. In SOPs (Standard Operation Procedures), you determine which rules, events or key figures trigger a CAPA process. Are there already complaints about a product or have deviations been determined during an audit? Then use the advantages of an integrated software solution and link your CAPA project directly to the relevant cases in the other modules.

Identify and Correct Failure Causes

An essential prerequisite for the success of a CAPA project is a comprehensive analysis of the causes. Only when these causes are identified can the risks be assessed and effective corrective actions as well as lasting preventive actions be initiated. Thus similar deviations are quickly detected and faults avoided in the future. In BabtecQ, you can centrally keep track of all the actions that are to be implemented.

Keep your CAPA process under control and document it in an all-inclusive way. Flexible access authorizations allow you to map out responsibilities within the software and thus ensure data security. Important decisions are logged using electronic signatures. You can use the CAPA history to seamlessly retrieve these signatures at any time.

Complaints Management Complaints Management Reduce complaints - for satisfied customers and optimized processes. Task Management Action Management Task and Action Management Document tasks and measures directly in the relevant processes. Maintenance Preventive Maintenance Monitor machine performance and reduce disruptions.
Download
Contact Person
Simone Wagemeier
Simone Wagemeier
Sales
Phone: +49 202 4960-259
info@babtec.de
Cookie settings

Choose your preferred cookie settings

Details about cookies

Necessary Cookies
Some cookies are necessary for a website to function properly. We use them to:

  • Enable the safe operation of the site.
  • Provide authentication that allows you to log in to your account.
  • Remember your previous actions so that we can provide our services to you more quickly on your next visit.

Cookies for Statistics
Cookies for statistics can be used to collect information anonymously. They help us:

  • Find out which contents of our website are interesting for the visitor.
  • Analyze the behavior of our visitors within the individual pages.
  • Adapt our website to the needs of our visitors and constantly improve the contents.

Cookies for Marketing Purposes
Marketing cookies can be used to identify and track visitors of websites. We use them to:

  • Display more relevant advertising and content on websites.
  • Create digital marketing content to reach the right people with relevant information.
  • Prevent the same ads or content from being displayed repeatedly to the same people.

Cookie history