Carl Zeiss Industrial Quality So
ZEISS Industrial Quality Solutions has established guidelines and validation methods from extensive research to comply with FDA standards, including 21 CFR Part 11 and 21 CFR 820.
ZEISS has revealed that it's coordinate measuring machines (CMMs) will now offer 'validation solutions.' The multidimensional metrology solution provider’s latest offering will include a variety of solutions to aid manufacturers in meeting FDA standards.
Key information:
- ZEISS will now offer validation solutions for its ZEISS Coordinate Measuring Machines (CMMs).
- This new offering will help the CMMs achieve FDA compliance, with regulated quality assurance.
- The multidimensional metrology solutions provider will offer free eLearning courses and comprehensive, scalable solutions to help manufacturers validate their CMM systems.
Recognised validation of quality assurance systems, like CMMs, is an essential requirement within regulated industries. However, manufacturers often find it difficult to validate their software and systems, especially when they are new to the industry. It is common practice for businesses to ask CMM suppliers to provide FDA solutions and validation guidance.
After conducting its own research, as well as gathering customer feedback, ZEISS has unveiled its own validation solutions offering which complies with FDA standards.
"For many years the medical industry has debated and struggled with clear direction on how to validate CMMs, the metrology software, the part programs and the entire inspection process. Through our research and with customer feedback, we've defined clear solutions that are aligned with the FDA regulations," said Scott Lowen, Medical Industry Solutions Leader, and Software Product Manager for ZEISS Industrial Quality Solutions in the U.S.
ZEISS Industrial Quality Solutions will now offer a variety of validation services including free eLearning courses as well as comprehensive, scalable solutions for FDA-regulated manufacturers. The latter will validate CMM systems and inspection processes, while also providing instructions and support for validation, which is in accordance with FDA regulatory requirements from 21 CFR parts 11 and 820. As a result, CMM users will be able to speed up the integration time of their new quality assurance system.