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.

More about HYDRA for Life Science at

MPDV, headquartered in Mosbach/Germany, is the market leader for IT solutions in the manufacturing sector. With more than 40 years of project experience in the manufacturing environment, MPDV has extensive expertise and supports companies of all sizes on their way to the Smart Factory. Products such as MPDV–s Manufacturing Execution System (MES) HYDRA or the Manufacturing Integration Platform (MIP) enable manufacturing companies to streamline their production processes and stay one step ahead of the competition. The systems can be used to collect and evaluate production-related data along the entire value chain in real time. If the production process is delayed, employees detect it immediately and can initiate targeted measures. More than 900,000 people in over 1,400 manufacturing companies worldwide use MPDV–s innovative software solutions every day. This includes well-known companies from all sectors. The MPDV group employs around 500 people at 13 locations in China, Germany, Luxembourg, Malaysia, Singapore, Switzerland and the USA. Further information:

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