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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.
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.
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.
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.