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MPDV Mikrolab Blog

CAPA for regulated manufacturing companies

March 2020
Author: MPDV
Company: MPDV Mikrolab GmbH
CAPA for regulated manufacturing companies

Regulatory requirements dictate that companies working in the Life Science sector identify and solve problems in the manufacturing process and product at an early stage. These requirements are set out in ISO 13485, 21 CFR 820 and ISO 9000.

Both FDA inspectors and ISO auditors have an eye on whether companies are using the so-called CAPA process to identify, analyze, correct and address quality issues. Manufacturing companies can also reduce both rework and scrap.

With CAPA management, MPDV’s industry solution HYDRA for Life Science offers the opportunity to record problems in detail. In-depth analysis can detect key problem areas and take measures. The traceability function supports the user perfectly in their efforts to remove and stop problems. HYDRA for Life Science can inform personnel via workflows about generated measures including deadlines.

▶ Download | Press kit: HYDRA for Life Science CAPA (.zip)

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