Single Use & Newly Manufactured Device Cleaning Validations

January 15, 2018

Performing a cleaning validation during the initial phase of a device’s lifecycle aids manufacturers in complying with current good manufacturing practices (CGMP) and quality system (QS) regulation as set forth by FDA for medical device manufacturers. The data gathered during cleaning validations help manufacturers have confidence in the quality of their finished medical devices during on-site audits performed by both customers and regulators.

Spotlight

Biesse Group

Biesse Group is a multinational leader in the technology for processing wood, glass, stone, plastic and metal. It designs, manufactures and distributes machines, integrated systems and software for the producers of furniture, door/window frames, components for the construction, ship-building and aerospace industries.Invests on average 14 million Euros per year in R&D, boasting over 200 registered patents. Works via 9 industrial sites, 37 branches, 300 agents and selected resellers, exporting 85% of its production. Its customers include some of the most prestigious names of Italian and international design.

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whitePaper | February 21, 2022

Industry 4.0 presents a once in a lifetime opportunity to modernise and digitise the industrial arena, and that alone should be reason enough to delve further into its possibilities.

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whitePaper | June 3, 2022

Digital operations are key to maintaining a competitive edge, but most organizations today operate with a mix of different levels of automation, from completely automated to fully manual processes. This variation across the value chain impacts efficiency and customer satisfaction, since an end-to-end process may move through several disjointed manual and semi-automated tasks to reach completion. Moving to a fully digital operation with end-to-end intelligent automation can significantly improve existing business operations, while enabling true transformation: the creation of completely new business models that allow an organization to outperform the competition and expand into new markets.

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Spotlight

Biesse Group

Biesse Group is a multinational leader in the technology for processing wood, glass, stone, plastic and metal. It designs, manufactures and distributes machines, integrated systems and software for the producers of furniture, door/window frames, components for the construction, ship-building and aerospace industries.Invests on average 14 million Euros per year in R&D, boasting over 200 registered patents. Works via 9 industrial sites, 37 branches, 300 agents and selected resellers, exporting 85% of its production. Its customers include some of the most prestigious names of Italian and international design.

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