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In September 2022, the (FDA) released draft computer systems assurance (CSA) guidance clarifying software validation requirements for medical device manufacturers. The guidance significantly [...]

In FDA and ISO environments, quality audits are a process of examination and substantiation that procedures, records, and activities are effectively aligned with desired objectives. The FDA and [...]

Market changes and disruptions such as the global pandemic are driving companies to adopt Industry 4.0 in their manufacturing operations. Many companies are investing in smart manufacturing by [...]